Efficacy, safety, and dermal tolerability of dapsone gel, 7.5% in patients with moderate acne vulgaris: A pooled analysis of two phase 3 trials

Diane M. Thiboutot, Leon Kircik, Amy Mcmichael, Fran E. Cook-Bolden, Stephen K. Tyring, David R. Berk, Joan En Chang-Lin, Vince Lin, Alexandre Kaoukhov

Research output: Contribution to journalArticle

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Abstract

Objective:Assess efficacy and safety of once-daily topical dapsone gel, 7.5% compared with vehicle for treating acne vulgaris (acne). Design:A pooled analysis of data from two identically designed, randomized, double-blind, vehicle-controlled, multicenter, 12-week clinical trials. Setting: Study sites in the United States and Canada. Participants: overall, 4,340 patients were randomized 1:1 to dapsone and vehicle. Criteria included age 12 years or older with acne diagnosis, 20 to 50 facial inflammatory lesions (papules and pustules), 30 to 100 facial noninflammatory lesions (open and closed comedones), and acne grade of 3 (moderate) on the global Acne Assessment Score scale. Measurements: Efficacy assessments included the global Acne Assessment Score success rate (proportion of patients with global Acne Assessment Score of 0 [none] or 1 [minimal]) and percentage change from baseline in inflammatory and noninflammatory lesions at Week 12. Results: global Acne Assessment Score success rates were 29.8 percent and 21.1 percent for patients who received dapsone gel, 7.5% and vehicle, respectively (p<0.001). Patients receiving dapsone gel, 7.5% had greater percentage change in lesion counts than patients receiving vehicle (inflammatory lesions: -54.6% vs. -48.1%; p<0.001; -45.1%; noninNammatory lesions: -39.4%; p<0.001). Most adverse events were mild to moderate in severity. Mean dermal tolerability scores for stinging/burning, dryness, scaling, and erythema were similarly low with dapsone gel, 7.5% and vehicle. Conclusion:Dapsone gel, 7.5%, with a 50-percent greater dapsone concentration than twice-daily dapsone gel, 5% formulation, is applied topically once daily for acne, is effective, safe, and well-tolerated over 12 weeks, and has local tolerability similar to that of vehicle. www.clinicaltrials.gov identiMers: NCT01974141 and NCT01974323.

Original languageEnglish (US)
Pages (from-to)18-27
Number of pages10
JournalJournal of Clinical and Aesthetic Dermatology
Volume9
Issue number10
StatePublished - Oct 1 2016

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Dapsone
Acne Vulgaris
Gels
Safety
Skin
Erythema
Canada
Clinical Trials

All Science Journal Classification (ASJC) codes

  • Dermatology

Cite this

Thiboutot, Diane M. ; Kircik, Leon ; Mcmichael, Amy ; Cook-Bolden, Fran E. ; Tyring, Stephen K. ; Berk, David R. ; Chang-Lin, Joan En ; Lin, Vince ; Kaoukhov, Alexandre. / Efficacy, safety, and dermal tolerability of dapsone gel, 7.5% in patients with moderate acne vulgaris : A pooled analysis of two phase 3 trials. In: Journal of Clinical and Aesthetic Dermatology. 2016 ; Vol. 9, No. 10. pp. 18-27.
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title = "Efficacy, safety, and dermal tolerability of dapsone gel, 7.5{\%} in patients with moderate acne vulgaris: A pooled analysis of two phase 3 trials",
abstract = "Objective:Assess efficacy and safety of once-daily topical dapsone gel, 7.5{\%} compared with vehicle for treating acne vulgaris (acne). Design:A pooled analysis of data from two identically designed, randomized, double-blind, vehicle-controlled, multicenter, 12-week clinical trials. Setting: Study sites in the United States and Canada. Participants: overall, 4,340 patients were randomized 1:1 to dapsone and vehicle. Criteria included age 12 years or older with acne diagnosis, 20 to 50 facial inflammatory lesions (papules and pustules), 30 to 100 facial noninflammatory lesions (open and closed comedones), and acne grade of 3 (moderate) on the global Acne Assessment Score scale. Measurements: Efficacy assessments included the global Acne Assessment Score success rate (proportion of patients with global Acne Assessment Score of 0 [none] or 1 [minimal]) and percentage change from baseline in inflammatory and noninflammatory lesions at Week 12. Results: global Acne Assessment Score success rates were 29.8 percent and 21.1 percent for patients who received dapsone gel, 7.5{\%} and vehicle, respectively (p<0.001). Patients receiving dapsone gel, 7.5{\%} had greater percentage change in lesion counts than patients receiving vehicle (inflammatory lesions: -54.6{\%} vs. -48.1{\%}; p<0.001; -45.1{\%}; noninNammatory lesions: -39.4{\%}; p<0.001). Most adverse events were mild to moderate in severity. Mean dermal tolerability scores for stinging/burning, dryness, scaling, and erythema were similarly low with dapsone gel, 7.5{\%} and vehicle. Conclusion:Dapsone gel, 7.5{\%}, with a 50-percent greater dapsone concentration than twice-daily dapsone gel, 5{\%} formulation, is applied topically once daily for acne, is effective, safe, and well-tolerated over 12 weeks, and has local tolerability similar to that of vehicle. www.clinicaltrials.gov identiMers: NCT01974141 and NCT01974323.",
author = "Thiboutot, {Diane M.} and Leon Kircik and Amy Mcmichael and Cook-Bolden, {Fran E.} and Tyring, {Stephen K.} and Berk, {David R.} and Chang-Lin, {Joan En} and Vince Lin and Alexandre Kaoukhov",
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Thiboutot, DM, Kircik, L, Mcmichael, A, Cook-Bolden, FE, Tyring, SK, Berk, DR, Chang-Lin, JE, Lin, V & Kaoukhov, A 2016, 'Efficacy, safety, and dermal tolerability of dapsone gel, 7.5% in patients with moderate acne vulgaris: A pooled analysis of two phase 3 trials', Journal of Clinical and Aesthetic Dermatology, vol. 9, no. 10, pp. 18-27.

Efficacy, safety, and dermal tolerability of dapsone gel, 7.5% in patients with moderate acne vulgaris : A pooled analysis of two phase 3 trials. / Thiboutot, Diane M.; Kircik, Leon; Mcmichael, Amy; Cook-Bolden, Fran E.; Tyring, Stephen K.; Berk, David R.; Chang-Lin, Joan En; Lin, Vince; Kaoukhov, Alexandre.

In: Journal of Clinical and Aesthetic Dermatology, Vol. 9, No. 10, 01.10.2016, p. 18-27.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Efficacy, safety, and dermal tolerability of dapsone gel, 7.5% in patients with moderate acne vulgaris

T2 - A pooled analysis of two phase 3 trials

AU - Thiboutot, Diane M.

AU - Kircik, Leon

AU - Mcmichael, Amy

AU - Cook-Bolden, Fran E.

AU - Tyring, Stephen K.

AU - Berk, David R.

AU - Chang-Lin, Joan En

AU - Lin, Vince

AU - Kaoukhov, Alexandre

PY - 2016/10/1

Y1 - 2016/10/1

N2 - Objective:Assess efficacy and safety of once-daily topical dapsone gel, 7.5% compared with vehicle for treating acne vulgaris (acne). Design:A pooled analysis of data from two identically designed, randomized, double-blind, vehicle-controlled, multicenter, 12-week clinical trials. Setting: Study sites in the United States and Canada. Participants: overall, 4,340 patients were randomized 1:1 to dapsone and vehicle. Criteria included age 12 years or older with acne diagnosis, 20 to 50 facial inflammatory lesions (papules and pustules), 30 to 100 facial noninflammatory lesions (open and closed comedones), and acne grade of 3 (moderate) on the global Acne Assessment Score scale. Measurements: Efficacy assessments included the global Acne Assessment Score success rate (proportion of patients with global Acne Assessment Score of 0 [none] or 1 [minimal]) and percentage change from baseline in inflammatory and noninflammatory lesions at Week 12. Results: global Acne Assessment Score success rates were 29.8 percent and 21.1 percent for patients who received dapsone gel, 7.5% and vehicle, respectively (p<0.001). Patients receiving dapsone gel, 7.5% had greater percentage change in lesion counts than patients receiving vehicle (inflammatory lesions: -54.6% vs. -48.1%; p<0.001; -45.1%; noninNammatory lesions: -39.4%; p<0.001). Most adverse events were mild to moderate in severity. Mean dermal tolerability scores for stinging/burning, dryness, scaling, and erythema were similarly low with dapsone gel, 7.5% and vehicle. Conclusion:Dapsone gel, 7.5%, with a 50-percent greater dapsone concentration than twice-daily dapsone gel, 5% formulation, is applied topically once daily for acne, is effective, safe, and well-tolerated over 12 weeks, and has local tolerability similar to that of vehicle. www.clinicaltrials.gov identiMers: NCT01974141 and NCT01974323.

AB - Objective:Assess efficacy and safety of once-daily topical dapsone gel, 7.5% compared with vehicle for treating acne vulgaris (acne). Design:A pooled analysis of data from two identically designed, randomized, double-blind, vehicle-controlled, multicenter, 12-week clinical trials. Setting: Study sites in the United States and Canada. Participants: overall, 4,340 patients were randomized 1:1 to dapsone and vehicle. Criteria included age 12 years or older with acne diagnosis, 20 to 50 facial inflammatory lesions (papules and pustules), 30 to 100 facial noninflammatory lesions (open and closed comedones), and acne grade of 3 (moderate) on the global Acne Assessment Score scale. Measurements: Efficacy assessments included the global Acne Assessment Score success rate (proportion of patients with global Acne Assessment Score of 0 [none] or 1 [minimal]) and percentage change from baseline in inflammatory and noninflammatory lesions at Week 12. Results: global Acne Assessment Score success rates were 29.8 percent and 21.1 percent for patients who received dapsone gel, 7.5% and vehicle, respectively (p<0.001). Patients receiving dapsone gel, 7.5% had greater percentage change in lesion counts than patients receiving vehicle (inflammatory lesions: -54.6% vs. -48.1%; p<0.001; -45.1%; noninNammatory lesions: -39.4%; p<0.001). Most adverse events were mild to moderate in severity. Mean dermal tolerability scores for stinging/burning, dryness, scaling, and erythema were similarly low with dapsone gel, 7.5% and vehicle. Conclusion:Dapsone gel, 7.5%, with a 50-percent greater dapsone concentration than twice-daily dapsone gel, 5% formulation, is applied topically once daily for acne, is effective, safe, and well-tolerated over 12 weeks, and has local tolerability similar to that of vehicle. www.clinicaltrials.gov identiMers: NCT01974141 and NCT01974323.

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