Trial of Dapsone 5.0% Gel in the Treatment of Acne Vulgaris

• Register: ClinicalTrials.gov
• Last refreshed on: 9 January 2017
• Main ID: NCT02865005
• Date of registration: 01/07/2016
• Prospective Registration: No
• Primary sponsor: Seegpharm S.A.
• Public title: Trial of Dapsone 5.0% Gel in the Treatment of Acne Vulgaris
• Scientific title: A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study Comparing Dapsone 5% Gel (SEEGPharm SA) to Aczone® and Both Active Treatments Compared to Placebo (Vehicle) in the Treatment of Acne Vulgaris
• Date of first enrolment: February 2016
• Target sample size: 2361
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02865005
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Belize, United States

Contacts

• Name: Karen Lewis, MS
• Affiliation: Catawba Clinical Research

Key inclusion & exclusion criteria

Inclusion Criteria:

- Healthy male or non-pregnant females aged = 12 and = 40 years of age with a clinical
diagnosis of acne vulgaris.

- Informed Consent/Assent: For subjects 12 to 17 years of age inclusive must have
provided Institutional Review Board (IRB) approved written assent that must be
accompanied by an IRB approved written consent from the subject's legally acceptable
representatives (i.e., parent or guardian). In addition, all subjects or their
legally acceptable representatives must sign a Health Insurance Portability and
Accountability Act (HIPAA) authorization.

- On the face, subjects must have = 20 inflammatory lesions (i.e., papules and
pustules), AND = 25 non-inflammatory lesions (open and closed comedones) AND = 2
nodulocystic lesions (i.e., nodules and cysts). For the purposes of study treatment
and evaluation, all lesions on the face should be counted, including those on the
nose. Subjects may have acne lesions on other areas of the body (e.g., back, chest,
and arms) which should be excluded from the count, treatment and the IGA evaluation.

- Subjects must have an acne severity grade of 3 or 4 per the IGA

- Subjects must be willing to refrain from using all other topical acne medications or
antibiotics during the 12-week treatment period other than the study drug.

Exclusion Criteria:

- Prior or current concomitant therapies that would interfere with assessments in the
study.

- Prior or current concomitant therapies skin conditions that would interfere with
assessments in the study.

- Prior, current or planned procedures that would interfere with assessments in the
study.

- Current or planned activities that would interfere with assessment in the study.

- Subjects who have a Baseline local skin site reaction score of 3 [severe
(marked/intense)] for any signs and/or symptoms of irritation as scored using the
local skin site reaction scores.



Age minimum: 12 Years
Age maximum: 40 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Acne Vulgaris

Intervention(s)

Drug: Dapsone 5.0% Gel (SEEGPharm)

Other: Placebo

Drug: Dapsone 5.0% Gel (Allergan)

Primary Outcome(s)

Comparisons of Active Products: Mean percent change in the inflammatory lesion (papules and pustules) counts and non-inflammatory lesion (open and closed comedones) counts [Time Frame: Treatment Days: 84 days of dosing]

Secondary Outcome(s)

Clinical Success: Proportion of subjects with a clinical response of "success" [Time Frame: 12 Weeks]

Secondary ID(s)

SEEG-2015-6-23

Source(s) of Monetary Support

Please refer to primary and secondary sponsors