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M. Verschoore – One of the best experts on this subject based on the ideXlab platform.

  • a comparison of the efficacy and tolerability of Adapalene 0 1 gel versus tretinoin 0 025 gel in patients with acne vulgaris a meta analysis of five randomized trials
    British Journal of Dermatology, 1998
    Co-Authors: W J Cunliffe, M Poncet, C Loesche, M. Verschoore
    Abstract:

    The purpose of this meta-analysis was to determine if Adapalene 0.1% gel (Differin) provided superior efficacy and better tolerability than tretinoin 0.025% gel in the treatment of acne vulgaris. All comparative studies, both published and unpublished, from the United States and Europe, that fulfilled rigorous protocol criteria (multicentre, randomized, investigator-blind) were used. Five comparative studies met these criteria. In total, the meta-analysis evaluated 900 patients (450 treated with Adapalene 0.1% gel, 450 treated with tretinoin 0.025% gel) with mild-to-moderate acne from the combined clinical trials. To avoid study bias, the meta-analysis used an intention-to-treat analysis. Statistical methodology for the meta-analysis included analysis of covariance, analysis of variance and Cochran-Mantel-Haenszel test. All statistical tests were two-sided, with the 0.05 probability level used to establish statistical significance, and 95% confidence intervals used to assess equivalence. Adapalene demonstrated equivalent efficacy to tretinoin in terms of reducing total lesion count. Adapalene demonstrated more rapid efficacy, as evidenced by a significant difference in the reduction of inflammatory and total lesions at week 1. Adapalene also demonstrated considerably greater local tolerability at all evaluation periods. The findings from this meta-analysis suggest that Adapalene 0.1% gel constitutes a pharmacologic advance over such classic retinoids as tretinoin for the treatment of acne vulgaris.

  • Comparison of Adapalene 0.1% solution and tretinoin 0.025% gel in the topical treatment of acne vulgaris
    British Journal of Dermatology, 1998
    Co-Authors: Charles N. Ellis, Le Millikan, E. B. Smith, D. M. Chalker, Leonard J. Swinyer, I. H. Katz, R. S. Berger, O. H. Mills, M.d. Baker, M. Verschoore
    Abstract:

    A multicentre study was conducted to compare clinical safety and efficacy of Adapalene 0.1% solution and tretinoin 0.025% gel, both topical treatments for acne, in a once-daily dosage regimen for 12 weeks. A total of 297 patients were enrolled by eight investigators in this randomized, investigator-masked study in a parallel group design. An open label period using Adapalene followed this study to assess the long-term safety of Adapalene solution. Adapalene and tretinoin proved to be clinically and statistically effective in treating acne by reducing inflammatory (47% and 50%, respectively) and non-inflammatory lesions (57% and 54%) as compared to baseline. When comparing patients who had 75% or greater improvement in open comedones, Adapalene was shown to be significantly more effective than tretinoin. No serious adverse event was reported during this study, including during the long-term period. The reactions that occurred were similar between treatments, i.e. burning, pruritus, scaling, dryness and erythema.

  • comparison of Adapalene 0 1 solution and tretinoin 0 025 gel in the topical treatment of acne vulgaris
    British Journal of Dermatology, 1998
    Co-Authors: Charles N. Ellis, Le Millikan, E. B. Smith, D. M. Chalker, Leonard J. Swinyer, I. H. Katz, R. S. Berger, O. H. Mills, M.d. Baker, M. Verschoore
    Abstract:

    A multicentre study was conducted to compare clinical safety and efficacy of Adapalene 0.1% solution and tretinoin 0.025% gel, both topical treatments for acne, in a once-daily dosage regimen for 12 weeks. A total of 297 patients were enrolled by eight investigators in this randomized, investigator-masked study in a parallel group design. An open label period using Adapalene followed this study to assess the long-term safety of Adapalene solution. Adapalene and tretinoin proved to be clinically and statistically effective in treating acne by reducing inflammatory (47% and 50%, respectively) and non-inflammatory lesions (57% and 54%) as compared to baseline. When comparing patients who had 75% or greater improvement in open comedones, Adapalene was shown to be significantly more effective than tretinoin. No serious adverse event was reported during this study, including during the long-term period. The reactions that occurred were similar between treatments, i.e. burning, pruritus, scaling, dryness and erythema.

A Clucas – One of the best experts on this subject based on the ideXlab platform.

  • split face comparison of Adapalene 0 1 gel and tretinoin 0 025 gel in acne patients
    Journal of The American Academy of Dermatology, 1997
    Co-Authors: D Caron, Nabil Kerrouche, V Sorba, A Clucas
    Abstract:

    Abstract Background: Adapalene is a new naphthoic acid derivative developed for the topical treatment of acne vulgaris. Objective: We compared the skin tolerance of Adapalene 0.1% gel with tretinoin 0.025% gel in subjects with acne. Methods: Fifteen acne patient volunteers were enrolled in this investigator-masked, left-right comparison, randomized, controlled, intraindividual study. Adapalene 0.1% gel and tretinoin 0.025% gel were applied once a day to one half-face by the volunteers for 14 consecutive days. Clinical signs (erythema, desquamation, papules, vesicles, edema) and subjective symptoms (tightness, pruritus, burning) were evaluated and scored daily except on weekends. Results: Adapalene 0.1% gel was better tolerated than tretinoin 0.025% gel. The overall mean score calculated from all features combined was significantly higher with tretinoin gel than with Adapalene gel ( p = 0.002). Conclusion: Adapalene 0.1% gel was significantly less irritating than tretinoin 0.025% gel when tested in acne patients. (J Am Acad Dermatol 1997;36:S110-2.)

  • Adapalene 0 1 gel has low skin irritation potential
    Journal of The American Academy of Dermatology, 1997
    Co-Authors: M Verschoore, M Poncet, J Czernielewski, V Sorba, A Clucas
    Abstract:

    Abstract Background: Adapalene is a new naphthoic acid derivative with potent retinoid and antiinflammatory properties, developed for the topical treatment of acne vulgaris. Objective: We compare the cutaneous safety of Adapalene in different gel vehicles with tretinoin 0.025% gel. Methods: A total of 42 healthy human subjects were enrolled in two randomized, double-blind, controlled, intraindividual studies. In the first study (study A), Adapalene aqueous 0.03% and 0.1% gels were evaluated for their 21-day cumulative irritation potential compared with vehicle alone, patch alone, and tretinoin 0.025% gel under occlusion. In the second study (study B), Adapalene aqueous (0.03% and 0.1%) gels and Adapalene alcoholic (0.03% and 0.1%) gels were evaluated for their 5-day cumulative irritation potential compared with their respective vehicles and tretinoin 0.025% gel. Transepidermal water loss (TEWL) was measured daily at each visit. Results: In study A, Adapalene had a slight irritation potential that was in the same range as the gel vehicle and the patch alone, whereas tretinoin 0.025% gel was a severe irritant. In study B, no irritation was seen with either Adapalene aqueous gels or Adapalene gel vehicles or patch alone. The Adapalene alcoholic gels were slightly irritating, and tretinoin gel produced intense irritation reactions in the majority of subjects. TEWL increased fourfold at the tretinoin site but remained unchanged at all Adapalene sites. Conclusion: Adapalene 0.1% gel was significantly less irritating than tretinoin 0.025% gel. (J Am Acad Dermatol 1997;36:S104-9.)

  • skin tolerance of Adapalene 0 1 gel in combination with other topical antiacne treatments
    Journal of The American Academy of Dermatology, 1997
    Co-Authors: D Caron, V Sorba, A Clucas, M Verschoore
    Abstract:

    Abstract Background: Adapalene (Differin® gel) is a new naphthoic acid derivative developed for the topical treatment of acne vulgaris. Objective: We assessed, in healthy volunteers, the skin irritancy potential of three combinations, each including Adapalene 0.1% gel and one topical marketed antiacne product. Methods: Twenty-five healthy volunteers were enrolled in a 21-day cumulative irritancy study performed in a double-blind, randomized, controlled, intraindividual design. Five days a week, the three materials (benzoyl peroxide, clindamycin phosphate, and erythromycin) were applied in a nonocclusive manner either alone or in combination with Adapalene gel on seven cutaneous sites on the upper back. Adapalene was applied in the evening whereas the three other materials were applied in the morning. Irritation was evaluated and scored daily except on weekends. Results: All materials were well-tolerated when tested alone. The combinations of Adapalene 0.1% gel and either benzoyl peroxide, clindamycin phosphate, or erythromycin were also well-tolerated. The mean cumulative irritancy indices indicated that all three combinations were nonirritating. Conclusion: Under the conditions of the study, all tested treatments alone or in combination appeared nonirritating. (J Am Acad Dermatol 1997;36:S113-5.)

D Caron – One of the best experts on this subject based on the ideXlab platform.

  • skin tolerance of Adapalene 0 1 gel in combination with other topical antiacne treatments
    Journal of The American Academy of Dermatology, 1997
    Co-Authors: D Caron, V Sorba, A Clucas, M Verschoore
    Abstract:

    Abstract Background: Adapalene (Differin® gel) is a new naphthoic acid derivative developed for the topical treatment of acne vulgaris. Objective: We assessed, in healthy volunteers, the skin irritancy potential of three combinations, each including Adapalene 0.1% gel and one topical marketed antiacne product. Methods: Twenty-five healthy volunteers were enrolled in a 21-day cumulative irritancy study performed in a double-blind, randomized, controlled, intraindividual design. Five days a week, the three materials (benzoyl peroxide, clindamycin phosphate, and erythromycin) were applied in a nonocclusive manner either alone or in combination with Adapalene gel on seven cutaneous sites on the upper back. Adapalene was applied in the evening whereas the three other materials were applied in the morning. Irritation was evaluated and scored daily except on weekends. Results: All materials were well-tolerated when tested alone. The combinations of Adapalene 0.1% gel and either benzoyl peroxide, clindamycin phosphate, or erythromycin were also well-tolerated. The mean cumulative irritancy indices indicated that all three combinations were nonirritating. Conclusion: Under the conditions of the study, all tested treatments alone or in combination appeared nonirritating. (J Am Acad Dermatol 1997;36:S113-5.)

  • split face comparison of Adapalene 0 1 gel and tretinoin 0 025 gel in acne patients
    Journal of The American Academy of Dermatology, 1997
    Co-Authors: D Caron, Nabil Kerrouche, V Sorba, A Clucas
    Abstract:

    Abstract Background: Adapalene is a new naphthoic acid derivative developed for the topical treatment of acne vulgaris. Objective: We compared the skin tolerance of Adapalene 0.1% gel with tretinoin 0.025% gel in subjects with acne. Methods: Fifteen acne patient volunteers were enrolled in this investigator-masked, left-right comparison, randomized, controlled, intraindividual study. Adapalene 0.1% gel and tretinoin 0.025% gel were applied once a day to one half-face by the volunteers for 14 consecutive days. Clinical signs (erythema, desquamation, papules, vesicles, edema) and subjective symptoms (tightness, pruritus, burning) were evaluated and scored daily except on weekends. Results: Adapalene 0.1% gel was better tolerated than tretinoin 0.025% gel. The overall mean score calculated from all features combined was significantly higher with tretinoin gel than with Adapalene gel ( p = 0.002). Conclusion: Adapalene 0.1% gel was significantly less irritating than tretinoin 0.025% gel when tested in acne patients. (J Am Acad Dermatol 1997;36:S110-2.)

  • Split-face comparison of Adapalene 0.1% gel and tretinoin 0.025% gel in acne patients
    Journal of the American Academy of Dermatology, 1997
    Co-Authors: D Caron, Nabil Kerrouche, V Sorba, A Clucas
    Abstract:

    Abstract Background: Adapalene is a new naphthoic acid derivative developed for the topical treatment of acne vulgaris. Objective: We compared the skin tolerance of Adapalene 0.1% gel with tretinoin 0.025% gel in subjects with acne. Methods: Fifteen acne patient volunteers were enrolled in this investigator-masked, left-right comparison, randomized, controlled, intraindividual study. Adapalene 0.1% gel and tretinoin 0.025% gel were applied once a day to one half-face by the volunteers for 14 consecutive days. Clinical signs (erythema, desquamation, papules, vesicles, edema) and subjective symptoms (tightness, pruritus, burning) were evaluated and scored daily except on weekends. Results: Adapalene 0.1% gel was better tolerated than tretinoin 0.025% gel. The overall mean score calculated from all features combined was significantly higher with tretinoin gel than with Adapalene gel ( p = 0.002). Conclusion: Adapalene 0.1% gel was significantly less irritating than tretinoin 0.025% gel when tested in acne patients. (J Am Acad Dermatol 1997;36:S110-2.)

V Sorba – One of the best experts on this subject based on the ideXlab platform.

  • split face comparison of Adapalene 0 1 gel and tretinoin 0 025 gel in acne patients
    Journal of The American Academy of Dermatology, 1997
    Co-Authors: D Caron, Nabil Kerrouche, V Sorba, A Clucas
    Abstract:

    Abstract Background: Adapalene is a new naphthoic acid derivative developed for the topical treatment of acne vulgaris. Objective: We compared the skin tolerance of Adapalene 0.1% gel with tretinoin 0.025% gel in subjects with acne. Methods: Fifteen acne patient volunteers were enrolled in this investigator-masked, left-right comparison, randomized, controlled, intraindividual study. Adapalene 0.1% gel and tretinoin 0.025% gel were applied once a day to one half-face by the volunteers for 14 consecutive days. Clinical signs (erythema, desquamation, papules, vesicles, edema) and subjective symptoms (tightness, pruritus, burning) were evaluated and scored daily except on weekends. Results: Adapalene 0.1% gel was better tolerated than tretinoin 0.025% gel. The overall mean score calculated from all features combined was significantly higher with tretinoin gel than with Adapalene gel ( p = 0.002). Conclusion: Adapalene 0.1% gel was significantly less irritating than tretinoin 0.025% gel when tested in acne patients. (J Am Acad Dermatol 1997;36:S110-2.)

  • Adapalene 0 1 gel has low skin irritation potential
    Journal of The American Academy of Dermatology, 1997
    Co-Authors: M Verschoore, M Poncet, J Czernielewski, V Sorba, A Clucas
    Abstract:

    Abstract Background: Adapalene is a new naphthoic acid derivative with potent retinoid and antiinflammatory properties, developed for the topical treatment of acne vulgaris. Objective: We compare the cutaneous safety of Adapalene in different gel vehicles with tretinoin 0.025% gel. Methods: A total of 42 healthy human subjects were enrolled in two randomized, double-blind, controlled, intraindividual studies. In the first study (study A), Adapalene aqueous 0.03% and 0.1% gels were evaluated for their 21-day cumulative irritation potential compared with vehicle alone, patch alone, and tretinoin 0.025% gel under occlusion. In the second study (study B), Adapalene aqueous (0.03% and 0.1%) gels and Adapalene alcoholic (0.03% and 0.1%) gels were evaluated for their 5-day cumulative irritation potential compared with their respective vehicles and tretinoin 0.025% gel. Transepidermal water loss (TEWL) was measured daily at each visit. Results: In study A, Adapalene had a slight irritation potential that was in the same range as the gel vehicle and the patch alone, whereas tretinoin 0.025% gel was a severe irritant. In study B, no irritation was seen with either Adapalene aqueous gels or Adapalene gel vehicles or patch alone. The Adapalene alcoholic gels were slightly irritating, and tretinoin gel produced intense irritation reactions in the majority of subjects. TEWL increased fourfold at the tretinoin site but remained unchanged at all Adapalene sites. Conclusion: Adapalene 0.1% gel was significantly less irritating than tretinoin 0.025% gel. (J Am Acad Dermatol 1997;36:S104-9.)

  • skin tolerance of Adapalene 0 1 gel in combination with other topical antiacne treatments
    Journal of The American Academy of Dermatology, 1997
    Co-Authors: D Caron, V Sorba, A Clucas, M Verschoore
    Abstract:

    Abstract Background: Adapalene (Differin® gel) is a new naphthoic acid derivative developed for the topical treatment of acne vulgaris. Objective: We assessed, in healthy volunteers, the skin irritancy potential of three combinations, each including Adapalene 0.1% gel and one topical marketed antiacne product. Methods: Twenty-five healthy volunteers were enrolled in a 21-day cumulative irritancy study performed in a double-blind, randomized, controlled, intraindividual design. Five days a week, the three materials (benzoyl peroxide, clindamycin phosphate, and erythromycin) were applied in a nonocclusive manner either alone or in combination with Adapalene gel on seven cutaneous sites on the upper back. Adapalene was applied in the evening whereas the three other materials were applied in the morning. Irritation was evaluated and scored daily except on weekends. Results: All materials were well-tolerated when tested alone. The combinations of Adapalene 0.1% gel and either benzoyl peroxide, clindamycin phosphate, or erythromycin were also well-tolerated. The mean cumulative irritancy indices indicated that all three combinations were nonirritating. Conclusion: Under the conditions of the study, all tested treatments alone or in combination appeared nonirritating. (J Am Acad Dermatol 1997;36:S113-5.)

W J Cunliffe – One of the best experts on this subject based on the ideXlab platform.

  • randomised controlled trial of the efficacy and safety of Adapalene gel 0 1 and tretinoin cream 0 05 in patients with acne vulgaris
    European Journal of Dermatology, 2002
    Co-Authors: W J Cunliffe, William F Danby, Frank Dunlap, Michael H Gold, David Gratton, Alan Greenspan
    Abstract:

    Background. Previous clinical trials have shown that Adapalene gel produces less irritation than tretinoin gels and tretinoin 0.025% cream. Short term results have shown that Adapalene is less irritating than tretinoin gels and creams. This study is the first to compare the 0.1% formulation of Adapalene gel with the 0.05% strength of tretinoin cream in a formal clinical trial. Objective. To investigate the efficacy and tolerability of Adapalene gel 0.1% compared with tretinoin cream 0.05% in patients with mild-to-moderate acne vulgaris. Methods. Ten-week, multicentre, randomised, investigator-masked, active-controlled, parallel group study in 409 patients with acne vulgaris. Results. Adapalene gel 0.1% demonstrated equivalent efficacy in reduction of acne lesion counts and global improvement of acne severity over 10 weeks’ treatment and was significantly better tolerated than tretinoin cream 0.05% in terms of erythema, dryness, desquamation and stinging/burning. Conclusion. Adapalene gel 0.1% showed equivalent efficacy and was significantly better tolerated than tretinoin cream 0.05% in patients with mild-to-moderate acne vulgaris.

  • a comparison of the efficacy and tolerability of Adapalene 0 1 gel versus tretinoin 0 025 gel in patients with acne vulgaris a meta analysis of five randomized trials
    British Journal of Dermatology, 1998
    Co-Authors: W J Cunliffe, M Poncet, C Loesche, M. Verschoore
    Abstract:

    The purpose of this meta-analysis was to determine if Adapalene 0.1% gel (Differin) provided superior efficacy and better tolerability than tretinoin 0.025% gel in the treatment of acne vulgaris. All comparative studies, both published and unpublished, from the United States and Europe, that fulfilled rigorous protocol criteria (multicentre, randomized, investigator-blind) were used. Five comparative studies met these criteria. In total, the meta-analysis evaluated 900 patients (450 treated with Adapalene 0.1% gel, 450 treated with tretinoin 0.025% gel) with mild-to-moderate acne from the combined clinical trials. To avoid study bias, the meta-analysis used an intention-to-treat analysis. Statistical methodology for the meta-analysis included analysis of covariance, analysis of variance and Cochran-Mantel-Haenszel test. All statistical tests were two-sided, with the 0.05 probability level used to establish statistical significance, and 95% confidence intervals used to assess equivalence. Adapalene demonstrated equivalent efficacy to tretinoin in terms of reducing total lesion count. Adapalene demonstrated more rapid efficacy, as evidenced by a significant difference in the reduction of inflammatory and total lesions at week 1. Adapalene also demonstrated considerably greater local tolerability at all evaluation periods. The findings from this meta-analysis suggest that Adapalene 0.1% gel constitutes a pharmacologic advance over such classic retinoids as tretinoin for the treatment of acne vulgaris.

  • Clinical efficacy and safety comparison of Adapalene gel and tretinoin gel in the treatment of acne vulgaris: Europe and U.S. multicenter trials.
    Journal of the American Academy of Dermatology, 1997
    Co-Authors: W J Cunliffe, R Caputo, B Dreno, L Förström, M Heenen, C E Orfanos, Y Privat, A Robledo Aguilar, J Meynadier, M Alirezai
    Abstract:

    Adapalene is a new chemical entity that exhibits tretinoin-like activities in the terminal diffdifferentiation process. We evaluated a dose range effect of two concentrations of Adapalene gel as acne treatment and compared Adapalene 0.1% gel with tretinoin 0.025% gel in the treatment of acne patients in two large multicenter studies. Multicenter, investigator-masked, parallel group studies including 89 acne patients in the dose range study and 591 patients in the concurrent controlled studies were conducted. Adapalene gel 0.1% was significantly more effective in treating acne lesions than 0.03% Adapalene gel. Adapalene gel 0.1% was significantly more effective than 0.025% or tretinoin gel in one study and of the same effectiveness in the other study. Adapalene gel was always better tolerated than tretinoin gel. Adapalene 0.1% gel is a safe and effective treatment of acne vulgaris.