NCT01974323

A Safety and Efficacy Study to Compare Dapsone Dermal Gel With Vehicle Control in Patients With Acne Vulgaris

Completed Phase 3 Results posted Last updated 5 October 2018

What this trial tests

Phase 3 trial testing Dapsone Gel in Acne Vulgaris in 2,238 participants. Completed in 1 October 2014.

Timeline

1 November 2013

Primary endpoint
1 October 2014

1 October 2014

Quick facts

Lead sponsor	Almirall, S.A.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	2,238
Start date	1 November 2013
Primary completion	1 October 2014
Estimated completion	1 October 2014
Sites	3 locations across United States, Canada

Drugs / interventions tested

• Dapsone Gel — full drug profile →
• Dapsone Gel Vehicle — full drug profile →

Conditions studied

• Acne Vulgaris — all drugs for Acne Vulgaris →

Sponsor

Almirall, S.A. — full company profile →

Who can join

12 and older, any sex, with Acne Vulgaris. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Percentage of Patients With a Score of 0 (None) or 1 (Minimal) on the 5-point Global Acne Assessment Score (GAAS)
  Time frame: Week 12
  The Investigator evaluated the patient's acne severity using the 5-point GAAS scale with 0 being none and 4 being severe. The complete scale is as follow: Grade 0 (none) = No evidence of facila acne vulgaris; Grade 1 (minimal) = Few noninflammatory lesions (comedones) are present, a few inflammatory lesions (papules/pustules) may be present, no nodulo-cyctic lesions are allowed; Grade 2 (mild) = S
• Change From Baseline in Inflammatory Facial Lesion Counts
  Time frame: Baseline, Week 12
  The Investigator evaluated the patient's inflammatory lesions (papule, pustule and nodule/cyst). A negative change from baseline indicates a reduction in lesion counts (improvement) and a positive change from baseline indicates an increase in lesion counts (worsening).
• Change From Baseline in Noninflammatory Facial Lesion Counts
  Time frame: Baseline, Week 12
  The Investigator evaluated the patient's noninflammatory lesions (papule, pustule and nodule/cyst). A negative change from baseline indicates a reduction in lesion counts (improvement) and a positive change from baseline indicates an increase in lesion counts (worsening).

Sponsor's own description

This study will assess the safety and efficacy of dapsone gel versus vehicle control in patients with acne vulgaris.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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 DM, Kircik L, McMichael A, Cook-Bolden FE, et al · · 2016 · cited 4× · PMID 27847545
2. Once-Daily Topical Dapsone Gel, 7.5%: Effective for Acne Vulgaris Regardless of Baseline Lesion Count, With Superior Efficacy in Females
   Tanghetti E, Harper J, Baldwin H, Kircik L, et al · · 2018 · cited 1× · PMID 30500141
3. Once-Daily Topical Dapsone Gel, 7.5%: Effective for Acne Vulgaris Regardless of Baseline Lesion Count, With Superior Efficacy in Females
   Tanghetti E, Harper J, Baldwin H, Kircik L, et al · · 2018 · PMID 30500140
4. Once-Daily Topical Dapsone Gel, 7.5%: Effective for Acne Vulgaris Regardless of Baseline Lesion Count, With Superior Efficacy in Females
   Tanghetti E, Harper J, Baldwin H, Kircik L, et al · · 2018 · PMID 30500139