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At least 19 recordsLinked to original sources
PubMed2003

A randomized comparison of an emollient containing skin-related lipids with a petrolatum-based emollient as adjunct in the treatment of chronic hand dermatitis.

Hand dermatitis is a multifactorial skin disorder in which skin barrier impairment is involved in the pathogenesis. The development of topical agents that improve skin barrier function is therefore a promising approach for the management of hand dermatitis. Topically applied lipids may interfere with skin barrier function, and emollients containing skin-related lipids have been suggested to facilitate repair of the skin barrier. However, evidence for the superiority of emollients containing skin-related lipids over the more traditional emollients is still lacking. The aim of this study was to compare an emollient containing skin-related lipids (Locobase Repair) with a traditional petrolatum-based emollient for the management of hand dermatitis. Adult males and females (n = 30) with mild to moderate chronic hand dermatitis were treated twice daily for 2 months either with an emollient containing skin-related lipids or with a pet.-based emollient. In the case of exacerbation, the patients of both treatment groups were allowed to use a mild corticosteroid according to instructions. Both treatment regimes significantly improved clinical signs of hand dermatitis as assessed by the investigator global assessment, hand eczema area and severity score. We did not observe significant differences in the improvement of clinical signs, itching, patients' assessment of efficacy, cosmetic acceptability or usage of topical corticosteroids between both treatment groups. In conclusion, this study confirms that the frequent use of emollients may be useful in the therapy of hand dermatitis. However, we could not demonstrate the superiority of this particular emollient containing skin-related lipids in patients with chronic hand dermatitis.

Administration, Topical↗
PubMed2006

Modulation of ultraviolet (UV) transmission by emollients: relevance to narrowband UVB phototherapy and psoralen plus UVA photochemotherapy.

BACKGROUND: Patients with psoriasis undergoing or about to undergo ultraviolet (UV) phototherapy and photochemotherapy often have thick scale on their plaques which can prevent the penetration of UV radiation. Emollients are used to moisturize the skin and to prevent or reduce some of the milder side-effects ('dryness', itching) sometimes experienced during UV therapy. However, emollients can alter the UV transmission of skin and thus may alter the clinical effects of phototherapy and photochemotherapy. OBJECTIVES: We tested 30 of the topical emollients in the British National Formulary (BNF) using a standard in vitro technique used to test sunscreens. We also surveyed U.K. phototherapy units to establish routine practice for emollient use in phototherapy and photochemotherapy. METHODS: We used a standard in vitro technique to measure the monochromatic protection factors (MPFs) of 30 non-bath emollients from the BNF. An application rate of 2 mg cm-2 was used. For the assessment of effects during narrowband UVB (TL-01) phototherapy, the mean of the protection factors at 310 and 315 nm was calculated; for psoralen plus UVA photochemotherapy the mean UVA protection factor was used. A questionnaire survey was used to assess routine practice concerning emollient use prior to phototherapies in phototherapy units throughout the U.K. RESULTS: In the UVA range, 17 of the 30 emollients gave protection factors of 1.2 or above. In the UVB range, 23 of 30 had an MPF of 1.2 or above. Yellow soft paraffin had the highest protection factor in the UVB range. Of 78 centres surveyed, 57 returned completed questionnaires (73%). Seventeen of 57 (30%) centres routinely used emollients immediately prior to administering phototherapy treatments. The remaining 40 of 57 (70%) did not. Forty-five (79%) responding centres recommended the use of emollients after phototherapy. CONCLUSIONS: This study has revealed considerable variability in the practice of emollient use before phototherapy treatments. Although the majority of centres included in this study did not routinely use emollients, almost one third did. Our in vitro measurement of 30 emollients revealed marked variation in UV transmission, with many emollients blocking sufficient UV to affect the response to therapy.

Drug Utilization↗
PubMed1992

Tretinoin emollient cream: a new therapy for photodamaged skin.

BACKGROUND: Tretinoin administered topically in 0.1% concentration has been shown to improve the wrinkling and irregular pigmentation of photoaged skin. OBJECTIVE: The purpose of this study was to assess the safety and efficacy of various concentrations of tretinoin in a new emollient cream base in the treatment of photoaged skin. METHODS: Three concentrations of tretinoin (0.05%, 0.01%, and 0.001%) in a new emollient cream formulation were compared with vehicle in a 24-week, double-blind, randomized, multicenter study of 296 subjects with photodamaged facial skin. RESULTS: Tretinoin emollient cream 0.05% gave a significantly better global response to therapy than vehicle (p less than 0.001), with 68% of subjects exhibiting improvement at the end of therapy, compared with 43% of subjects in the vehicle group. An excellent or good response was found in 26% of subjects treated with tretinoin emollient cream 0.05% versus 11% of vehicle-treated subjects. Fine wrinkling, mottled hyperpigmentation, and roughness were more improved in subjects who received tretinoin emollient cream 0.05% than in vehicle-treated subjects (p less than 0.05). No significant difference was found between vehicle and tretinoin emollient cream 0.01% or 0.001%. Histologic examination showed increases in epidermal and granular layer thickness, decreased melanin content and compaction of the stratum corneum after therapy with tretinoin emollient cream 0.05% or 0.01%. Mild to moderate skin reactions, such as erythema, peeling, and burning, were the most common side effects and, although most prevalent in the group using the 0.05% concentration, generally did not limit tretinoin use. CONCLUSION: Tretinoin emollient cream 0.05% appears to be safe and effective in the treatment of photodamaged skin.

Administration, Topical↗
PubMed2003

Twice weekly fluticasone propionate added to emollient maintenance treatment to reduce risk of relapse in atopic dermatitis: randomised, double blind, parallel group study.

OBJECTIVE: To explore the efficacy and safety of fluticasone propionate, cream and ointment, applied twice weekly in addition to maintenance treatment with emollients, in reducing the risk of relapse of chronic recurrent atopic dermatitis. DESIGN: Randomised, double blind, parallel group study of 20 weeks' duration. SETTING: Dermatology outpatient clinics (6 countries, 39 centres). PARTICIPANTS: Adult (aged 12-65) patients with moderate to severe atopic dermatitis who were experiencing a flare. METHODS: Participants applied fluticasone propionate (0.05% cream or 0.005% ointment; once or twice daily) regularly for four weeks to stabilise their condition. The patients whose disease was brought under control then continued into a 16 week maintenance phase, applying emollient on a daily basis with a bath oil as needed and either the same formulation of fluticasone propionate or its placebo base (emollient alone) twice weekly to the areas that were usually affected. MAIN OUTCOME MEASURE: Time to relapse of atopic dermatitis during maintenance phase. RESULTS: 376 patients entered the stabilisation phase, and 295 continued into the maintenance phase. After 16 weeks in the maintenance phase, the disease remained under control in 133 patients (87 using fluticasone propionate twice weekly, 46 using emollient alone), 135 (40 fluticasone propionate, 95 emollient) had experienced a relapse, and 27 had discontinued. Median time to relapse was six weeks for emollient alone compared with more than 16 weeks for additional fluticasone propionate. Patients who applied fluticasone propionate cream twice weekly were 5.8 times less likely (95% confidence interval 3.1 to 10.8, P < 0.001) and patients using fluticasone propionate ointment 1.9 times less likely (1.2 to 3.2, P=0.010) to have a relapse than patients applying emollient alone. The groups showed no differences in adverse events. CONCLUSION: After atopic dermatitis had been stabilised the addition of fluticasone propionate twice weekly to maintenance treatment with emollients significantly reduced the risk of relapse.

Adolescent↗
PubMed2003

The use of emollients as sophisticated therapy in dermatology.

Emollients are agents designed to make the stratum corneum softer and more plant by increasing its hydration. A large number of preparations are available today, many of which are marketed as cosmetic and therapeutic moisturizers. They are the most prescribed products in dermatology. Their structure and function are surprisingly complex and sophisticated, and many are equidistant between cosmetics and drugs. The use of the emollients corrects the problems in scaling disorders. It is well known that the electrical properties of the stratum corneum change after application of an emollient. It is also possible that they have suppressive effects on epidermal thickening. Emollients have an anti-inflammatory activity and also give some transient relief from irritation. In clinical use emollients are employed as treatments for ichthyoses, xeroderma and disorders of keratinization, atopic dermatitis, psoriasis, and photodamaged skin. Emollients of the new millennium include agents that mimic natural ingredients and function as botanicals, including vitamins, hydroxy acids, and retinoids. Emollients can cause a few side effects, such as irritant dermatitis, allergic contact dermatitis, fragrance allergy or allergy to other constituents (preservatives or additives), stinging, cosmetic acne, and pigmentary disorders. We can conclude that emollients, continuously evolving to ever more sophisticated products, are very important in the treatment of different dermatoses.

Dermatitis, Allergic Contact↗
PubMed1991

Skin replica analysis of photodamaged skin after therapy with tretinoin emollient cream.

Computerized image analysis of silicone replicas, a reproducible, objective technique for measuring skin topography, was used in addition to clinical measures in two multicenter, double-blind, randomized, controlled studies of tretinoin emollient cream, a new formulation for treating photodamaged skin. Previously, the skin replica technique had been successfully used in a pilot study of tretinoin 0.05% cream by one investigator. In the present studies, subjects treated for 24 weeks with tretinoin emollient 0.05% cream consistently showed more improvement in skin topography than did vehicle-treated patients. A 0.01% concentration of tretinoin emollient cream also improved skin topography to a greater extent than the vehicle, while the lowest concentration tested (0.001%) showed little difference from vehicle. These results, reflecting a smoothening of the skin surface in tretinoin emollient cream-treated subjects, were consistent with clinical data showing greater improvement in fine wrinkling and roughness after tretinoin emollient cream therapy than after vehicle therapy. Findings from these multicenter studies confirm the value of the skin replica technique and help establish the efficacy of tretinoin emollient 0.05% cream for photodamaged skin.

Adult↗
PubMed2002

Effect of a lipid-rich emollient containing ceramide 3 in experimentally induced skin barrier dysfunction.

In the present study we compared the effect of a ceramide 3-containing emollient (Locobase(R) Repair) with a control emollient (vaselinum album/cremor lanette ana) and untreated damaged skin using clinical, bioengineering and immunohistochemical methods in two different models of experimentally induced skin barrier dysfunction. In model A (n = 13) skin barrier dysfunction was inflicted at three investigation sites by tape stripping. In model B (n = 13) the volunteers were patch tested at three investigation sites with sodium dodecyl sulphate (0.2%) for 4 h a day for 4 consecutive days. The investigation sites were treated once a day with the above-mentioned agents. Irritant reaction was assessed daily by erythema scoring and measurements of transepidermal water loss (TEWL). After 5D, punch biopsies were taken from all sites. Immunohistochemical assessment was carried out with respect to epidermal proliferation, epidermal differentiation and Langerhans cells. Tape stripping resulted in an erythematous reaction and an increase of TEWL associated with up-regulation of cycling cells, involucrin and expression of cytokeratin 16. At day 4, ceramide 3-containing emollient significantly decreased (p < 0.03) the erythema score, TEWL and cycling cells in comparison with the untreated site. Repetitive exposure to SDS induced a variable degree of erythema, gradual increase of TEWL, an increase of cycling cells, and up-regulation of involucrin, E-FABP and SKALP. The treatment with the control emollient significantly prevented erythema, increase of TEWL and cycling cells at day 4 compared to the untreated site. In summary, the present study demonstrated that both tested emollients improve skin barrier in different conditions compared to the untreated skin. There is some indication that formulations containing skin-related lipids might be of benefit in barrier disruption following tape stripping. Different models and clinical trials are needed to establish the usefulness in specific conditions of emollients containing skin-related lipids.

Administration, Cutaneous↗
PubMed2000

Interaction of commonly used emollients with photochemotherapy.

BACKGROUND/AIM: Even though emollients are commonly used in combination with photochemotherapy, we still lack guidance for the selection of the appropriate emollient to be used in combination with photochemotherapy. The purpose of our study was to determine the interaction of commonly used emollients with photochemotherapy. METHODS: The study was carried on 75 healthy volunteers. In order to assess the effects of five different emollients--white petrolatum, 3% salicylic acid in white petrolatum, Balmandol, Decubal and Urederm hydro--the subjects were divided into five groups. Minimal phototoxic dose (MPD) was determined by irradiating two rows of six circular test fields on the back of the subjects with increasing doses of UVA. One of the emollients listed above was applied to the skin under the upper rows alternatively, whereas the lower rows served as control. RESULTS: Application of Urederm hydro and Decubal before exposure to UVA resulted in a statistically significant decrease in the MPD in all subjects. Even though application of white petrolatum and white petrolatum containing 3% salicylic acid decreased the MPD in most of the subjects and Balmandol application slightly increased the MPD, the results did not reach statistical significance. CONCLUSIONS: According to our findings, it is probable that the total dose of UVA needed to cause clearing of psoriasis would be decreased by application of Urederm hydro and Decubal prior to photochemotherapy. We noted a slight photoprotective effect of Balmandol in the UVA range, but this finding has to be further studied. Clinical studies are needed to clarify the effects of these emollients on the course and outcome of photochemotherapy.

Analysis of Variance↗
PubMed2002

Advised best practice for the use of emollients in eczema and other dry skin conditions.

The recent Dermatological Care Working Group report highlighted important deficiencies in the dermatology service in the UK and recommended that care should move closer to the patient. The report stated that 'expert patients' could become 'sharers in their care' and are best placed to improve their own self management. One area that could benefit greatly from increased patient education and participation is the use of emollients. Emollients are frequently prescribed for patients with eczema and other dry skin conditions. Although the benefits of emollient therapy are widely accepted, prescribing practices vary considerably, often according to physicians' individual preferences. Patients can receive confusing or conflicting treatment advice, leading to frustration, non-compliance, and difficulty in following an effective regimen. To promote the effective use of emollients it is important for patients and health professionals to understand the functions of the skin and the principles of emollient use and application. We propose a set of simple guidelines for emollient therapy in eczema care to improve day-to-day management by health professionals in the community and to promote consistent practices by patients. These guidelines form the ABC dry skin and eczema management programme supported by the National Eczema Society and accredited by the British Skin Foundation.

Eczema↗
PubMed2004

Effect of skin care with an emollient containing a high water content on mild uremic pruritus.

Skin care is very important for preventing uremic pruritus. However, mild uremic pruritus has usually been treated with antihistamine and urea-containing ointments. We therefore examined the effects of an aqueous gel with higher water content. Twenty hemodialysis patients with mild pruritus who were not being treated with any emollient were divided into two groups of 10 each. Patients in one group were treated with an aqueous gel containing 80% water. This emollient was applied twice daily for 2 weeks. No emollient was applied for the next 2 weeks. The other group of patients were not treated with any emollient for the 4 weeks. Visual analog scale scores for itching in the experimental group at week 2 were significantly decreased compared with that at week 0 (3.5 +/- 0.3 vs 0.6 +/- 0.2, P < 0.01). Skin dryness in the experimental group was significantly improved at week 2 compared with that at week 0. The visual analog scale score for itching increased to 1.2 +/- 0.5 and skin dryness reappeared in 40% of patients by week 4, i.e. after the emollient was stopped. There were no significant changes in the control group during the study. It is concluded that the aqueous gel with high water content reduced itching and improved xerosis in patients with mild uremic pruritus. It is reasonable that skin care with an emollient containing a high water content is first started for hemodialysis patients with xerosis, even if they do not feel itching.

Aged↗
PubMed1998

Can glutathione-containing emollients inactivate methylchloroisothiazolinone/methylisothiazolinone?

Many persons are exposed to preservatives/biocides based on methylchloroisothiazolinone/methylisothiazolinone (MCI/MI), since toiletries and cosmetics, as well as products/water-based systems used occupationally, may all contain MCI/MI. In toiletries and cosmetics, the MCI/MI concentration is often below 15 ppm (0.0015%). In some industries, workers handle high concentrations of MCI/MI, which can cause chemical burns and induce sensitization if skin is exposed. Contact allergy to MCI/MI is common and reports on chemical burns have been published. Thus, there is a need for prevention of skin diseases caused by MCI/MI. The inactivation of MCI/MI by glutathione (GSH) in emollients, containing different amounts of lipids, was studied by HPLC. Various amounts of GSH were added to Fenuril, Essex, and Locobase, giving 3 preparations of each emollient containing 0.10%, 0.50% and 2.0% GSH, respectively. The inactivation of 15 ppm MCI/MI and the total inactivating capacity of GSH in these preparations, kept at room temperature and refrigerated, was studied over a period of 6 months. The inactivating capacity of GSH in the emollients was almost equivalent, regardless of the lipid contents of the emollients, type of storage and age. On the other hand, the GSH concentration in the emollients had a crucial importance on the inactivation of MCI/MI. Emollients containing 2% GSH were capable of inactivating up to 2400 ppm MCI/MI.

Dermatitis, Allergic Contact↗
PubMedDate not supplied

A guide to emollient therapy.

Although the benefits of emollient therapy have been widely acknowledged in dermatology treatments (Cork 1997), emollients have tended to be undervalued and under-used in general care and wound management. Healthy skin is an essential part of patient wellbeing, and emollient therapy is integral to the management of skin problems. The integration of tissue viability and dermatology services in the Plymouth Hospitals NHS Trust provided an opportunity to evaluate how and why emollient therapy is implemented. In practice, the authors have identified that healthcare practitioners need guidance and advice on emollient therapy to improve their care delivery. This article is based on the emollient therapy currently used in the authors' trust.

Algorithms↗
PubMed1997

Clobetasol propionate emollient 0.05 percent: hypothalamic-pituitary-adrenal-axis safety and four-week clinical efficacy results in plaque-type psoriasis.

Two clinical trials were conducted to evaluate the safety and antipsoriatic efficacy of a new 0.05 percent emollient formulation of clobetasol propionate (CP). In a crossover study of hypothalamic-pituitary-adrenal (HPA)-axis effects in 12 patients with psoriasis or eczema, 1.5 gm of CP emollient, applied to lesions twice daily for seven consecutive days, resulted in fewer patients with serum cortisol concentrations < 10 micrograms/100 mL than CP cream 0.05 percent (1vs 4); such concentrations were seen in two other patients during both treatment phases. A double-blind, randomized, parallel-group clinical trial in patients with moderate to severe plaque-type psoriasis showed that four weeks' treatment with CP emollient 0.43 to 0.5 gm twice daily (n = 35) was significantly more effective than emollient vehicle (n = 39) in reducing total signs/symptoms and scaling by Day 4, erythema and skin thickening by Day 8, and pruritus by Day 15. CP emollient was rated superior to vehicle by Day 4 in physician's gross assessment ratings and by Day 15 in patient's self-assessment ratings. In all assessments, CP emollient continued to be superior to vehicle during the remainder of the treatment period and two-week posttreatment period. No significant differences were observed in tolerability or serum cortisol effects during the course of the study.

Adult↗
PubMed2001

Eumovate (clobetasone butyrate) 0.05% cream with its moisturizing emollient base has better healing properties than hydrocortisone 1% cream: a study in nickel-induced contact dermatitis.

BACKGROUND: The emollient base of a topical corticosteroid, through its moisturizing properties, can be a useful treatment adjunct. OBJECTIVE: To compare the healing properties of Eumovate trade mark (clobetasone butyrate) 0.05% cream with its emollient base, hydrocortisone 1% cream and with no treatment. METHODS: A single-centre, double-blind, intra-individual, comparative study that involved 18 volunteers with nickel-induced contact dermatitis. Following a positive patch test to nickel, sub-therapeutic amounts (10 micro l = 3 mg cm(-2)) of each of the treatments were applied twice daily for seven days to each of the four test sites. RESULTS: In terms of the primary endpoint, a physician's global assessment after 7 days of treatment, clobetasone butyrate (CB) 0.05% cream showed a significantly better response than hydrocortisone (HC) 1% cream (78% vs 39%, difference -0.4, 95% CI -0.7 to -0.1; p = 0.046) or no treatment (78% vs 28%, difference -0.5, 95% CI -0.9 to -0.1; p = 0.016). CB 0.05% cream also showed a better response than its emollient base (78% vs 56%), though statistical significance was not achieved. In terms of moisturizing effects, there was no difference in transepidermal water loss (TEWL) between CB 0.05% cream and its emollient base. CB 0.05% cream treated sites did, however, have significantly lower values (i.e. were more moisturized) than untreated sites (difference -8.5, 95% CI -12.0 to -4.86; p < 0.001) or HC 1% treated sites (difference -7.1, 95% CI -11.0 to -3.4; p < 0.001). In terms of skin blanching activity, as expected the steroid-based creams achieved lower colorimetric values than the emollient base cream. CONCLUSIONS: These results from experimentally induced skin inflammation indicate that CB 0.05% (as Eumovate 0.05% cream) has both more effective anti-inflammatory activity and better moisturizing properties than hydrocortisone 1% cream and that these effects are in part due to its efficient emollient base.

Administration, Cutaneous↗
PubMed2000

Emollient ointment for preventing infection in preterm infants.

BACKGROUND: This section is under preparation and will be included in the next issue. OBJECTIVES: To assess the effect of prophylactic application of emollient ointment in preterm infants. SEARCH STRATEGY: Searches were made of the Oxford Database of Perinatal Trials, Medline (MeSH terms: ointment; limits: age groups, newborn infant; publication types, clinical trial), previous reviews including cross references, abstracts, conference and symposia proceedings, expert informants, and journal handsearching in the English language. SELECTION CRITERIA: Randomized controlled trials which compared the effect of prophylactic application of emollient ointment to routine care or as needed topical therapy in preterm infants are included in this review. DATA COLLECTION AND ANALYSIS: Data regarding clinical outcomes including transepidermal water loss, skin condition, fluid intake, suspect infection and proven nosocomial infection were excerpted from the reports of the clinical trials by the reviewers. Data analysis was done in accordance with the standards of the Cochrane Neonatal Review Group. MAIN RESULTS: Two randomized trials which compared prophylactic application of ointment to routine skin care or as needed topical ointment therapy were identified. Lane (1993) noted improved skin condition in infants receiving topical application of emollient ointment. In the study of Nopper and coworkers (1996), prophylactic application of ointment significantly decreased transepidermal water loss during the first six hours after initial application. Skin condition was noted to be improved during the first 1-2 weeks. Surveillance cultures demonstrated less bacterial colonization during the two week study. A significant decrease in suspect and proven infection was noted. Fewer infants were evaluated for sepsis among the group who received prophylactic application of ointment (relative risk 0. 50, 95% CI 0.27, 0.93; risk difference -0.30, 95% CI -0.54, -0.06). Both studies reported on the incidence of proven nosocomial infection. A trend towards a decrease in the risk of proven nosocomial infection was noted in infants who received prophylactic application of emollient ointment (typical relative risk 0.29, 95% CI 0.07, 1.16, typical risk difference -0.13, 95% CI -0.25, -0.01). REVIEWER'S CONCLUSIONS: In two small studies, prophylactic application of emollient ointment decreased transepidermal water loss, decreased the severity of dermatitis, and decreased the risk of suspect sepsis and proven sepsis. Further clinical studies are warranted to validate these results.

Cross Infection↗
PubMed1995

Effects of an antiperspirant with emollients on foot-sweat accumulation and blister formation while walking in the heat.

BACKGROUND: Friction blisters are a common injury in sports activities and military operations. Blisters can compromise performance, so it is important to devise preventive strategies to reduce these injuries. OBJECTIVE: This study investigated the influence of an antiperspirant with emollient additives on frequency and severity of friction blisters, hot spots, and irritant dermatitis. METHODS: Twenty-three healthy men walked on a treadmill (1.39 m/sec, 1% grade) in a warm environment (28 degrees C, 25% relative humidity) carrying a total mass of 21 +/- 1 kg. For 4 consecutive days before the walk, the subjects' feet were treated with either (1) an antiperspirant (20% aluminum zirconium tetrachlorohydrex glycine concentration plus water) with emollient additives, (2) emollient additives alone (placebo control), or (3) nothing (nontreated). In two separate trials (1 month apart) each participant received the antiperspirant treatment and both control treatments (emollient [placebo] and no treatment). RESULTS: No differences were seen among treatment conditions for sweat accumulation (p = 0.86), blister incidence (p = 0.36), hot spot incidence (p = 0.83), or blister severity (p = 0.31). Irritant dermatitis was not reported in any of the treatment conditions. CONCLUSION: The use of an antiperspirant with emollients reduces irritant dermatitis but does not reduce total foot-sweat accumulation, blister or hot spot incidence, or blister severity.

Adult↗
PubMed1997

A developmental toxicity study of tretinoin emollient cream (Renova) applied topically to New Zealand white rabbits.

BACKGROUND: Embryofetal developmental toxicity associated with oral administration of vitamin A analogs has led to concern about risks from topical application. OBJECTIVE: This study was conducted to evaluate the potential developmental toxicity of tretinoin emollient cream when applied to the skin of pregnant New Zealand white rabbits during organogenesis (gestational days 7 through 19). METHODS: Twenty rabbits each were randomly assigned to a control group (group I) or to receive vehicle (group II) or tretinoin emollient cream topically at dosages of 10 (0.05 mg/kg*, group III) or 100 (0.5 mg/kg*, group IV) times that used clinically in humans. Does and fetuses were examined for tretinoin-induced toxic effects, and maternal plasma tretinoin and metabolite levels were measured. RESULTS: The rate of abortion was increased significantly in does in group IV (p < or = 0.01) compared with the control group. Dosage-dependent increases in incidence and severity of skin reactions occurred in groups administered the vehicle and the two dosages of tretinoin. Does in groups III and IV had clinical and necropsy observations that were considered direct or indirect effects of tretinoin administration, persistent weight loss, and reduced feed consumption. Maternal endogenous plasma tretinoin levels were below the lower limit of quantitation of 5 ng/ml and were not significantly altered with treatment. Group IV had significantly reduced mean fetal body weight (p < or = 0.01) and a greater frequency of resorptions compared with group I. Although external, visceral, or skeletal alterations occurred at significantly greater levels in group III, they were unrelated to tretinoin administration because the fetal incidences were not dosage dependent, and the litter incidence did not significantly differ from the control group values. CONCLUSION: Maternally toxic dosages of tretinoin were associated with an increased incidence of abortions and resorptions and reduced fetal body weight, two end points of developmental toxicity. Consistent with the absence of detectable tretinoin plasma levels, however, no changes in fetal morphology were attributable to tretinoin administration. *The milligrams per kilogram dosage refers to the amount of active ingredient (tretinoin). The 0.05 mg/kg and 0.5 mg/kg groups were treated with 0.005% and 0.05% wt/wt tretinoin emollient cream formulation. The 0.05% tretinoin emollient cream is the Renova clinical formulation. The 10 and 100 times clinical multiples refer to Renova clinical multiples and are based on a 50 kg adult patient's applying 500 mg of 0.05% tretinoin emollient cream formulation daily to yield a clinical dosage of 0.005 mg/kg.

Abnormalities, Drug-Induced↗
PubMed2005

Emollients in a propanol-based hand rub can significantly decrease irritant contact dermatitis.

The objective of this study is to determine the effect of emollients in a propanol-based hand rub on skin dryness and erythema. In this prospective, randomized, controlled, double-blind trial, 35 subjects participated; of them approximately half were atopic (modified Erlanger atopy score > or =8). 2 propanol-based formulations were tested in a repeated open application test, 1 contained a mixture of emollients (0.81%, w/w). 2 aliquots of 0.7 ml of each formulation were applied twice per day over 2 weeks to the cubital fossa of each subject after random assignment of the preparations. Treatment areas were assessed before each application and 3 days postfinal application by visual inspection for erythema and dryness according to a standard scale. The sum score over all assessment time-points served as primary parameter. The mean sum score for erythema and dryness was significantly lower for the hand rub with emollients (0.8 +/- 2.4) in comparison with that for the hand rub without emollients (1.5 +/- 3.5; P = 0.022; Wilcoxon signed rank test). A comparison of the atopic and non-atopic subjects revealed no significant difference for any of the products (P > 0.05; Mann-Whitney U-test). It is concluded that the addition of emollients to a propanol-based hand rub can significantly decrease irritant contact dermatitis under frequent-use conditions.

Adult↗