Safety and Efficacy Trial of ACZONE (Dapsone) Gel, 7.5% in 9 to 11 Year-Old Patients With Acne Vulgaris
- Registration Number
- NCT02959970
- Lead Sponsor
- Almirall, S.A.
- Brief Summary
This study will evaluate the safety, tolerability, pharmacokinetics (PK) and efficacy of ACZONE Gel, 7.5% administered topically once-daily for 12 weeks in 9 to 11 year-olds with acne vulgaris.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
-Has acne vulgaris on the face, including the nose, with 20 to 100 total lesions (noninflammatory and/or inflammatory).
- Has uncontrolled systemic disease(s)
- Has severe cystic acne, acne conglobata, acne fulminans, or secondary acne (chloracne, drug-induced acne)
- Has used topical dapsone within 1 month prior to the screening
- Has used oral dapsone within 2 months prior to screening.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PK Cohort: ACZONE 7.5% dapsone gel Participants applied ACZONE 7.5 % gel topically, once-daily to the entire face, neck, upper chest, upper back and shoulders starting from Day 1 under maximal use conditions (2 grams per day) for Day 8 consecutive days, followed by a thin layer to their face and acne-affected areas on the upper chest, upper back, and shoulders for next 11 weeks. Non-PK Cohort: ACZONE 7.5% dapsone gel Participants applied ACZONE 7.5% gel topically, once-daily in a thin layer to their face and acne-affected areas on upper chest, upper back, and shoulders for 12 weeks.
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Events (AE) From Baseline (Day 1) until Week 12 An AE was defined as "any untoward medical occurrence in a clinical trial participant (regardless of the administration of the study drug and its causal relationship to it). An AE could therefore, be any unfavorable and unintended medical occurrence during the participant's participation in the trial, including deterioration of a pre-existing medical condition, an abnormal clinically significant finding in a laboratory assessment, or an abnormal clinically significant finding in the physical examination or vital sign.
Change From Baseline in Systolic and Diastolic Blood Pressure Baseline (Day 1), Week 12 Change from baseline in systolic and diastolic blood pressure was evaluated. Change from baseline was calculated by subtracting post-dose value from baseline value.
Change From Baseline in Heart Rate Baseline (Day 1), Week 12 Change from baseline in heart rate was evaluated. Change from baseline was calculated by subtracting post-dose value from baseline value.
Change From Baseline in Respiratory Rate Baseline (Day 1), Week 12 Change from baseline in respiratory rate was assessed. Change from baseline was calculated by subtracting post-dose value from baseline value.
Change From Baseline in Body Temperature Baseline (Day 1), Week 12 Change from baseline in body temperature was assessed. Change from baseline was calculated by subtracting post-dose value from baseline value.
Change From Baseline in Weight Baseline (Day 1), Week 12 Change from baseline in weight was assessed. Change from baseline was calculated by subtracting post-dose value from baseline value.
Change From Baseline in Height Baseline (Day 1), Week 12 Change from baseline in height was assessed. Change from baseline was calculated by subtracting post-dose value from baseline value.
Local Dermal Tolerability: Number of Participants With Dryness, Scaling and Erythema as Assessed by Investigator Week 12 Local dermal tolerability was evaluated by investigator in terms of presence and absence of dryness, scaling and erythema symptoms and its severity in the areas of body where medication was applied. These symptoms were assessed by using a 4 - point scale of 0 - 3, where 0 = none (no dryness, scaling and erythema) and 3 = severe (marked roughness, heavy scale production and intense redness). The higher score indicated severe symptoms.
Local Dermal Tolerability: Number of Participants With Stinging/Burning Symptoms as Assessed by Participants Week 12 Local dermal tolerability was evaluated by participants in terms of presence and absence of prickling pain sensation immediately after (within 5 minutes of dosing) and its severity in the areas of body where medication was applied (face). Stinging/burning symptoms were graded on a 4-point scale of 0 - 3 where 0 = none (no stinging/burning), 1 = mild (slight warm, tingling/stinging sensation; not really bothersome), 2 = moderate (definite warm, tingling/stinging sensation that is somewhat bothersome), 3 = severe (hot, tingling/stinging sensation that has caused definite discomfort). The higher score indicated severe symptoms.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (20)
Redwood Family Dermatology
🇺🇸Santa Rosa, California, United States
Skin Specialists, PC
🇺🇸Omaha, Nebraska, United States
DermResearch, LLC
🇺🇸Austin, Texas, United States
Hamzavi Dermatology
🇺🇸Fort Gratiot, Michigan, United States
University of Texas Medical School at Houston
🇺🇸Houston, Texas, United States
Austin Institute for Clinical Research, Inc.
🇺🇸Pflugerville, Texas, United States
Department of Dermatology, UPCII
🇺🇸Hershey, Pennsylvania, United States
Dermresearch, PLLC
🇺🇸Louisville, Kentucky, United States
Kirklin Clinic
🇺🇸Birmingham, Alabama, United States
Center for Dermatology Clinical Research
🇺🇸Fremont, California, United States
Southern California Dermatology
🇺🇸Santa Ana, California, United States
Quest Dermatology Research
🇺🇸Northridge, California, United States
Saint Louis University Dermatology
🇺🇸Saint Louis, Missouri, United States
Center for Clinical and Cosmetic Research
🇺🇸Aventura, Florida, United States
Skin Specialty Dermatology
🇺🇸New York, New York, United States
Baumann Cosmetic and Research Institute
🇺🇸Miami Beach, Florida, United States
KGL Skin Study Center
🇺🇸Broomall, Pennsylvania, United States
Health Sciences/Department of Dermatology
🇺🇸Winston-Salem, North Carolina, United States
Arlington Research Center, Inc.
🇺🇸Arlington, Texas, United States
Premier Clinical Research
🇺🇸Spokane, Washington, United States