Search PubMed⌕ Search

Biomedical subjects

J P Ortonne

Publications and source records attributed to J P Ortonne.

At least 19 recordsLinked to original sources
PubMed2006

The safety of hydroquinone.

Hydroquinone is one of the most effective molecules for the treatment of hyperpigmentary disorders, with over 40 years of efficacy and safety data. Concerns over its safety have been raised because of the fact that it is a derivative of benzene and because of the long-term side-effects observed with cosmetic products containing high concentrations of hydroquinone. However, despite 40-50 years use of hydroquinone for medical conditions, there has not been a single documented case of either a cutaneous or internal malignancy associated with this drug. This article reviews the evidence for the safety of hydroquinone in the treatment of hyperpigmentation conditions.

Animals↗
PubMed2006

Efficacy and safety of a new single-dose terbinafine 1% formulation in patients with tinea pedis (athlete's foot): a randomized, double-blind, placebo-controlled study.

BACKGROUND: Tinea pedis is a common dermatophyte infection with frequent recurrences. Terbinafine (presently used as a 1-week topical treatment of tinea pedis) is now available in a novel topical solution (film-forming solution--FFS), developed to allow single application. OBJECTIVES: To demonstrate the efficacy and safety of terbinafine 1% FFS in a randomized, double-blind, placebo-controlled, phase III trial, and to determine relapse or re-infection rate of tinea pedis at 12 weeks. PATIENTS/METHODS: Fifty-four centres (27 in France; 27 in Germany) enrolled 273 evaluable patients (2 : 1 randomization). Patients applied terbinafine 1% FFS or placebo only once between, under and over the toes, soles and sides of both feet. Efficacy assessments included direct microscopy, mycological culture, and clinical signs and symptoms at baseline, and at weeks 1, 6 and 12 after the single drug application. RESULTS: Effective treatment (negative mycology plus absent/minimal symptoms) at week 6 in the terbinafine 1% FFS group was 63%; vehicle was 17% (P<or=0.0001). Mycological cure was 72% in the terbinafine group and 21% in the placebo (P<or=0.0001) at week 6. Clinical signs/symptoms decreased significantly in the active group compared to the placebo. The self-assessment of itching and burning sensation by the patient showed a clear reduction in symptoms starting 15 min after treatment application (this could be attributed to the cooling effect of the FFS). Recurrence (positive culture at 3 months) occurred in 12.5% of the effectively treated patients at week 6 in the terbinafine group. FFS was well tolerated. CONCLUSION: Terbinafine 1% FFS, single dose application is an effective, safe and convenient treatment for tinea pedis. The relapse/re-infection rate 3 months after the end of single-dose therapy is similar to that previously demonstrated in a study using terbinafine 1% cream for 7 days.

Administration, Topical↗
PubMed2005

Comparative study of the impact of chronic urticaria, psoriasis and atopic dermatitis on the quality of life.

BACKGROUND: A better management of chronic skin disorders (CSDs) requires a knowledge of their impact from the patient's point of view. OBJECTIVES: To determine which aspects of the patient's life are mainly impaired in the different CSDs, and provide comparative references to estimate better the real impact of the different CSDs. PATIENTS AND METHODS: A prospective cross-sectional and matched study of 1356 adult outpatients to compare the health-related quality of life (HRQL) profile in chronic urticaria (466 CU), psoriasis (464 PSO) and atopic dermatitis (426 AD), using the VQ-Dermato, a multidimensional instrument in French validated for CSDs. RESULTS: After adjustment for confounders, HRQL dimensions were differently affected in the three CSDs. The 'physical discomfort' dimension was more degraded in AD and CU than in PSO (P < 0.001), and 'leisure activities' more in PSO than in CU (P < 0.001). 'Self-perception' and 'treatment-induced restrictions' dimensions were much less affected in CU than in PSO and AD (P < 0.001). In PSO, the 'daily living activities' dimension was much less impaired than in CU and AD (P < 0.001). No aspect of HRQL was really spared in AD. CONCLUSIONS: The comparison shows that CU, PSO and AD are characterized by completely different qualitative profiles of impact on HRQL, which are influenced by their clinical characteristics and usual treatment options. It underlines the severe impairment of CU which is often underestimated.

Adult↗
PubMed2005

A multicentre, randomized, double-blind, controlled study of long-term treatment with 0.1% tacrolimus ointment in adults with moderate to severe atopic dermatitis.

BACKGROUND: Atopic dermatis (AD) is a chronic disease that often requires long-term treatment. Topical corticosteroids are the usual therapy for patients with AD, but prolonged usage can result in skin atrophy and other side-effects. OBJECTIVES: In a randomized, double-blind, comparative study, to compare the efficacy and safety of a 6-month treatment period with 0.1% tacrolimus ointment vs. a corticosteroid ointment regimen in adults with moderate to severe AD. METHODS: Treatment was applied twice daily for a maximum of 6 months. Patients in the tacrolimus treatment group (n = 487) applied 0.1% tacrolimus ointment to all affected areas over the whole body. The patients treated with the corticosteroid regimen (n = 485) applied 0.1% hydrocortisone butyrate ointment to affected areas on the trunk and extremities and 1% hydrocortisone acetate ointment to affected areas on the face and neck. The study primary endpoint was the response rate, i.e. the proportion of patients with at least 60% improvement in the modified Eczema Area and Severity Index (mEASI) between baseline and month 3. RESULTS: By month 3, more patients in the 0.1% tacrolimus group responded to treatment (72.6% vs. 52.3% in the corticosteroid group, P < 0.001). The patients treated with 0.1% tacrolimus also showed greater improvement in mEASI, EASI, affected body surface area and physician and patient assessments of global response. Patients applying 0.1% tacrolimus ointment experienced more skin burning (52.4% vs. 13.8% in the corticosteroid group; P < 0.001). In most patients, skin burning was mild to moderate in severity and decreased rapidly after the first week of treatment. There was no increase in the incidence of infections or malignancies over time in either treatment group. CONCLUSIONS: Long-term treatment with 0.1% tacrolimus ointment is significantly more efficacious than a corticosteroid ointment regimen in adults with moderate to severe AD.

Adult↗
PubMed2005

An open-label study of alefacept plus ultraviolet B light as combination therapy for chronic plaque psoriasis.

BACKGROUND: Alefacept, a fully human LFA-3/IgG(1) fusion protein, is a selective biological agent approved in the United States for the treatment of chronic plaque psoriasis. In phase 3 trials, clinical improvement and prolonged off-treatment remission of psoriasis correlated with reductions in circulating memory T cells. Reductions in pathogenic epidermal T cells in psoriatic lesions also have been noted following phototherapy with ultraviolet B (UVB) light. Because alefacept and UVB target T cells in different ways, combination therapy with these two agents may lead to greater efficacy. OBJECTIVES: To determine the safety, tolerability, and efficacy trends of combination therapy with alefacept plus UVB light in patients with chronic plaque psoriasis. METHODS: In an open-label, parallel-group study conducted at two sites, one in France and one in the United States, patients with chronic plaque psoriasis who were candidates for phototherapy received 12-weekly intramuscular injections of alefacept, 15 mg. In addition, patients were randomized to one of three treatment arms: no UVB treatment, 6-week UVB treatment, and 12-week UVB treatment. UVB treatment consisted of narrowband (NB) UVB at the site in France and broadband (BB) UVB at the site in the United States. The 12-week treatment period was followed by a 12-week follow-up period. Clinic visits occurred weekly during treatment and every 2-4 weeks during follow-up. RESULTS: A total of 60 patients (n = 30/site) were enrolled in the study. Alefacept was well tolerated when administered in combination with UVB treatment and as monotherapy. There was no evidence of increased phototoxicity or photosensitivity with the combination. At each study site, alefacept/UVB provided a higher overall response rate and led to a more rapid onset of response compared with alefacept monotherapy. Of patients who achieved > or = 50% reduction from baseline Psoriasis Area Severity Index (PASI 50) at 2 weeks after the last dose of alefacept, 75-100% in the combination therapy groups maintained this response throughout follow-up in the absence of further psoriasis therapy. CONCLUSIONS: In patients with chronic plaque psoriasis, combination therapy with alefacept plus short-term (6-12 weeks) UVB treatment is well tolerated with a trend toward greater and more rapid efficacy than alefacept alone.

Adult↗
PubMed2005

The right dose in the right place: an overview of current prescription, instruction and application modalities for topical psoriasis treatments.

BACKGROUND: Compared to treatment success with oral medications, treatment success with topical treatments is currently difficult to achieve. AIM: To assess and compare existing methods of lesion size evaluation, prescription habits, instruction and application modalities of topical medications. METHODS: Review of current and new procedures to estimate the body surface area, to calculate the most adequate quantity of medication to be prescribed, to instruct patients and to assess the individual dosing procedures of topical treatments. RESULTS: The most accurate method to assess the body surface area remains the rule of nine, allowing, together with a recently developed calculation disc, to estimate the most adequate quantity of topical treatment (here calcitriol 3 g/g ointment) to be prescribed. Precise instructions to the patient are other important elements for the successful treatment of dermatoses. Dosing devices, such as a spatula, may help patients to dose their daily topical treatment, avoiding over- and underdosing of the medication. CONCLUSION: A correct evaluation of the lesions sizes, a precise calculation of the treatments quantity to be prescribed, clear instructions and treatment-specific individual dosing devices may help to achieve higher patient compliance and treatment success.

Administration, Topical↗
PubMed2004

Treatment of vitiligo by 308-nm excimer laser: an evaluation of variables affecting treatment response.

BACKGROUND AND OBJECTIVES: To determine the true efficacy of the 308-nm excimer laser for the treatment of vitiligo, while taking into account confounding factors such as anatomic site of treatment, age, sex, skin type, MED, and duration of evolution of the vitiligo. STUDY DESIGN/MATERIALS AND METHODS: Thirty-five patients with vitiligo were included. Each lesion was treated twice a week by the 308-nm excimer laser for a maximum of 24 sessions. Efficacy was blindly evaluated by two independent physicians. RESULTS: Repigmentation was noted in 46 plaques/52 (88.5%). Repigmentation rate (75%) was obtained in 14 (26.9%). In "UV sensitive" areas (face, neck, trunk), 8/14 lesions (57.1%) had a repigmentation rate, 75% versus 6/38 (15.8%) in "UV resistant" areas (bony prominences and extremities) (P = 0.031). No relationship could be established between response to the treatment and the following variables: age, sex, skin type, MED, and duration of evolution of the vitiligo (respectively, P = 1, 0.666, 0.566, 0.628, 0.521). CONCLUSIONS: An aesthetically reasonable result is achieved essentially in "UV sensitive" areas, thus appearing to be the appropriate places of choice for this treatment.

Adolescent↗
PubMed2004

PI3K mediates protection against TRAIL-induced apoptosis in primary human melanocytes.

Melanocytes are cells of the epidermis that synthesize melanin, which is responsible for skin pigmentation. Transformation of melanocytes leads to melanoma, a highly aggressive neoplasm, which displays resistance to apoptosis. In this report, we demonstrate that TNF-related apoptosis-inducing ligand (TRAIL), which was thought to kill only transformed cells, promotes very efficiently apoptosis of primary human melanocytes, leading to activation of caspases 8, 9 and 3, and the cleavage of vital proteins. Further, we show that stem cell factor (SCF), a physiologic melanocyte growth factor that activates both the phosphatidyl-inositol-3 kinase (PI3K) and the extracellular regulated kinase (ERK) pathways, strongly protects melanocytes from TRAIL and staurosporine killing. Interestingly, inhibition of PI3K or its downstream target AKT completely blocks the antiapoptotic effect of SCF, while inhibition of ERK has only a moderate effect. Our data indicate that protection evoked by SCF/PI3K/AKT cascade is not mediated by an increase in the intracellular level of FLIP. Further, only a sustained PI3K activity can protect melanocytes from apoptosis, thereby indicating that the PI3K/AKT pathway plays a pivotal role in melanocyte survival. The results gathered in this report bring new information on the molecular mechanisms involved in primary melanocyte apoptosis and survival that would help to better understand the process by which melanomas acquire their resistance to apoptosis.

Apoptosis↗
PubMed2004

Efficacy of once-daily treatment regimens with calcipotriol/betamethasone dipropionate ointment and calcipotriol ointment in psoriasis vulgaris.

BACKGROUND: A two-compound ointment containing calcipotriol 50 micro g g-1 and betamethasone dipropionate 0.5 mg g-1 has recently been shown to be an effective treatment for psoriasis. OBJECTIVES: This study was designed to investigate efficacy and safety of different treatment regimens with the two-compound product (Daivobet/Dovobet; LEO Pharma, Ballerup, Denmark) and calcipotriol 50 micro g g-1 ointment (Daivonex/Dovonex; LEO Pharma). METHODS: In total, 972 patients with psoriasis vulgaris were randomized to one of three treatment regimens: group 1, the two-compound product once daily for 8 weeks followed by calcipotriol ointment once daily for 4 weeks; group 2, the two-compound product once daily for 4 weeks followed by 8 weeks of treatment with calcipotriol ointment once daily on weekdays and the two-compound product once daily at weekends; and group 3, calcipotriol ointment twice daily for 12 weeks. The efficacy was evaluated by Psoriasis Area and Severity Index (PASI) and investigators' global assessments of disease severity. The primary response criteria were percentage reduction in PASI and proportion of patients with absent/very mild disease according to the investigators' global assessments after 8 weeks of treatment. RESULTS: The mean reduction in PASI from baseline to the end of 8 weeks of treatment was 73.3% for group 1, 68.2% for group 2 and 64.1% for group 3. The proportion of patients with absent/very mild disease at the end of 8 weeks of treatment was 55.3% for group 1, 47.7% for group 2 and 40.7% for group 3. For both primary response criteria, group 1 was statistically superior to group 3 (P < 0.001), whereas group 2 did not differ significantly from group 3. The difference between group 1 and group 2 was statistically significant with regard to PASI but not regarding the proportion of patients with absent/very mild disease. Patients receiving initial therapy with the two-compound product achieved the fastest treatment response, and the maximum treatment effect for these patients was seen after 5 weeks. This effect was maintained with continued treatment with the two-compound product for up to 8 weeks. After 12 weeks of treatment, no significant differences were seen between the three groups with regard to reduction in PASI, whereas the proportion of patients with absent/very mild disease in group 2 was superior to that in group 3. Patients receiving therapy with the two-compound product experienced fewer lesional/perilesional adverse drug reactions than the calcipotriol-treated patients (P < 0.001): 10.9% in group 1, 11.5% in group 2 and 22.3% in group 3. CONCLUSIONS: Two different short-term treatment regimens employing a recently developed two-compound product (calcipotriol/betamethasone dipropionate) provided rapid and marked clinical efficacy and were shown to be safe therapies for psoriasis vulgaris.

Adolescent↗
PubMed2003

Intra-individual comparison of the cutaneous safety and efficacy of calcitriol 3 microg g(-1) ointment and calcipotriol 50 microg g(-1) ointment on chronic plaque psoriasis localized in facial, hairline, retroauricular or flexural areas.

BACKGROUND: Psoriasis involving sensitive skin areas remains difficult to treat because of the side-effects of topical corticosteroids and the irritancy potential of vitamin D3 derivatives. Several clinical trials have demonstrated that calcitriol, the naturally occurring and hormonally active form of vitamin D3, is effective and safe at the dose of 3 microg g(-1) for the treatment of psoriasis affecting the trunk and limbs. METHODS: We compared the safety and efficacy of calcitriol 3 microg g(-1) ointment and calcipotriol 50 microg g(-1) ointment in a multicentre, randomized, investigator-blinded, left-right comparison in mild to moderate chronic plaque psoriasis affecting sensitive areas, defined as being the face, hairline, retroauricular and flexural areas. One pair of symmetrical and bilateral target lesions was selected from each area and assessed for perilesional erythema, oedema, and stinging/burning. Global assessment of local tolerability and global improvement were rated by the investigator, and the subjects were asked to evaluate the tolerability and efficacy of each product and to express their global preference. RESULTS: In the 75 subjects, calcitriol and calcipotriol both led to clearing of at least one target lesion in 21 (28%) of the subjects each. Perilesional erythema (P < 0.001), perilesional oedema (P < 0.02) and stinging/burning (P < 0.001) were all significantly less severe with calcitriol than with calcipotriol. The subjects' evaluation of local tolerability was significantly (P < 0.0001) in favour of calcitriol. Ten treatment-related dermatological events occurred in eight subjects, including one subject who experienced skin discomfort on both sides. All other events occurred only on the calcipotriol-treated side (irritant dermatitis, six subjects; contact dermatitis, one subject). Global assessment of improvement from baseline by the investigators was significantly greater for the calcitriol-treated lesions (P < 0.02). The subjects' global preference was significantly in favour of calcitriol (P < 0.02). CONCLUSIONS: In the present study, calcitriol ointment was found to be better tolerated and would appear to be more effective than calcipotriol ointment in the treatment of psoriasis in sensitive areas.

Adolescent↗
PubMed2003

Diagnostic and neural analysis of skin cancer (DANAOS). A multicentre study for collection and computer-aided analysis of data from pigmented skin lesions using digital dermoscopy.

BACKGROUND: Early detection of melanomas by means of diverse screening campaigns is an important step towards a reduction in mortality. Computer-aided analysis of digital images obtained by dermoscopy has been reported to be an accurate, practical and time-saving tool for the evaluation of pigmented skin lesions (PSLs). A prototype for the computer-aided diagnosis of PSLs using artificial neural networks (NNs) has recently been developed: diagnostic and neural analysis of skin cancer (DANAOS). OBJECTIVES: To demonstrate the accuracy of PSL diagnosis by the DANAOS expert system, a multicentre study on a diverse multinational population was conducted. METHODS: A calibrated camera system was developed and used to collect images of PSLs in a multicentre study in 13 dermatology centres in nine European countries. The dataset was used to train an NN expert system for the computer-aided diagnosis of melanoma. We analysed different aspects of the data collection and its influence on the performance of the expert system. The NN expert system was trained with a dataset of 2218 dermoscopic images of PSLs. RESULTS: The resulting expert system showed a performance similar to that of dermatologists as published in the literature. The performance depended on the size and quality of the database and its selection. CONCLUSIONS: The need for a large database, the usefulness of multicentre data collection, as well as the benefit of a representative collection of cases from clinical practice, were demonstrated in this trial. Images that were difficult to classify using the NN expert system were not identical to those found difficult to classify by clinicians. We suggest therefore that the combination of clinician and computer may potentially increase the accuracy of PSL diagnosis. This may result in improved detection of melanoma and a reduction in unnecessary excisions.

Adult↗
PubMed2002

Treatment of vitiligo by topical calcipotriol.

OBJECTIVE: Evaluation of the efficiency of topical calcipotriol monotherapy in vitiligo. MATERIALS AND METHODS: This was a prospective, right/left comparative, open study at the Dermatology Department at the University Hospital in Nice, France. Twenty-four patients with localized or generalized vitiligo with symmetrical lesions were included. The main outcome measure was the evaluation of the percentage of repigmentation in treated target lesions and untreated control lesions for each patient. RESULTS AND CONCLUSIONS: Topical calcipotriol in monotherapy is not an effective treatment of vitiligo.

Administration, Topical↗
PubMed2002

A new calcipotriol/betamethasone formulation with rapid onset of action was superior to monotherapy with betamethasone dipropionate or calcipotriol in psoriasis vulgaris.

In this study, we compared a new combination ointment containing both calcipotriol and betamethasone dipropionate with betamethasone dipropionate ointment (Diprosone) and calcipotriol ointment (Daivonex) in patients with psoriasis vulgaris; 1106 patients were randomized to twice daily double-blind treatment with combination, betamethasone dipropionate or calcipotriol for 4 weeks. Patients then received twice daily calcipotriol, unblinded, for a further 4 weeks. Mean percentage change in PASI at end of the double-blind phase was -74.4 (combination group), -61.3 (betamethasone group) and -55.3 (calcipotriol group). Mean difference (95% Cl) combination-betamethasone was -13.1 (-16.9 to -9.3, p < 0.001) and for combination-calcipotriol -19.0 (-22.8 to -15.2, p <0.001). The differences in PASI were also statistically significant after 1 week. In the double-blind phase, 8.1% of patients (combination) reported lesional/ perilesional adverse reactions compared to 4.7% (betamethasone) and 12.0% (calcipotriol). In the combination group, mean PASI at the end of the double-blind phase was 2.5, and at end of the unblinded phase 3.6, compared with 3.9 and 4.1 (betamethasone) and 4.4 and 3.7 (calcipotriol). Calcipotriol/betamethasone combination is more effective and has a more rapid onset of action than either active constituent used alone, and is well tolerated. It is safe to transfer patients from combination to calcipotriol, with maintenance of clinical effect.

Administration, Topical↗