Clinical trial NCT02959970: Safety and Efficacy Trial of ACZONE (Dapsone) Gel, 7.5% in 9 to 11 Year-Old Patients With Acne Vulgaris
Official title: An Open-Label Phase 4 Safety and Efficacy Trial of ACZONE (Dapsone) Gel, 7.5% in 9 to 11 Year-Old Patients With Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acne Vulgaris
Lead sponsor: Almirall, S.A.
Sponsor class: INDUSTRY
Collaborators: name: Allergan
First posted: 2016-11-09
Enrollment: 100
Sex: ALL
Minimum age (years): 9
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

-Has acne vulgaris on the face, including the nose, with 20 to 100 total lesions (noninflammatory and/or inflammatory).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of Participants With Adverse Events (AE)
timeFrame: From Baseline (Day 1) until Week 12
measure: Change From Baseline in Systolic and Diastolic Blood Pressure
timeFrame: Baseline (Day 1), Week 12
measure: Change From Baseline in Heart Rate
timeFrame: Baseline (Day 1), Week 12
measure: Change From Baseline in Respiratory Rate
timeFrame: Baseline (Day 1), Week 12
measure: Change From Baseline in Body Temperature
timeFrame: Baseline (Day 1), Week 12
measure: Change From Baseline in Weight
timeFrame: Baseline (Day 1), Week 12
measure: Change From Baseline in Height
timeFrame: Baseline (Day 1), Week 12
measure: Local Dermal Tolerability: Number of Participants With Dryness, Scaling and Erythema as Assessed by Investigator
timeFrame: Week 12
measure: Local Dermal Tolerability: Number of Participants With Stinging/Burning Symptoms as Assessed by Participants
timeFrame: Week 12
Secondary outcomes:
Other outcomes:
measure: Peak Plasma Concentration of Dapsone,Dapsone Hydroxylamine and N-acetyl Dapsone at Week 1
timeFrame: Week 1 (Pre-dose and 10 hours post-dose)
measure: Trough Plasma Concentration of Dapsone, Dapsone Hydroxylamine and N-acetyl Dapsone at Week 1
timeFrame: Week 1 (Pre-dose)
measure: Absolute Change From Baseline in Inflammatory Lesion Counts
timeFrame: Baseline (Day 1), Week 12
measure: Percent Change From Baseline in Inflammatory Lesion Counts
timeFrame: Baseline (Day 1), Week 12
measure: Absolute Change From Baseline in Non-inflammatory Lesion Counts
timeFrame: Baseline (Day 1), Week 12
measure: Percent Change From Baseline in Non-inflammatory Lesion Counts
timeFrame: Baseline (Day 1), Week 12
measure: Absolute Change From Baseline in Total Lesion Counts on Face
timeFrame: Baseline (Day 1), Week 12
measure: Percent Change From Baseline in Total Lesion Counts on Face
timeFrame: Baseline (Day 1), Week 12
measure: Percentage of Participants With None (0) or Minimal (1) Score on the Investigator's Global Assessment (IGA) for Face
timeFrame: Week 12
measure: Percentage of Participants With None (0) or Minimal (1) Score Plus at Least a 2-Grade Improvement on the Investigator's Global Assessment (IGA) for Face
timeFrame: Week 12
Locations:
city: Birmingham
country: United States
facility: Kirklin Clinic
state: Alabama
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research
state: California
city: Northridge
country: United States
facility: Quest Dermatology Research
state: California
city: Santa Ana
country: United States
facility: Southern California Dermatology
state: California
city: Santa Rosa
country: United States
facility: Redwood Family Dermatology
state: California
city: Aventura
country: United States
facility: Center for Clinical and Cosmetic Research
state: Florida
city: Miami Beach
country: United States
facility: Baumann Cosmetic and Research Institute
state: Florida
city: Louisville
country: United States
facility: Dermresearch, PLLC
state: Kentucky
city: Fort Gratiot
country: United States
facility: Hamzavi Dermatology
state: Michigan
city: Saint Louis
country: United States
facility: Saint Louis University Dermatology
state: Missouri
city: Omaha
country: United States
facility: Skin Specialists, PC
state: Nebraska
city: New York
country: United States
facility: Skin Specialty Dermatology
state: New York
city: Winston-Salem
country: United States
facility: Health Sciences/Department of Dermatology
state: North Carolina
city: Broomall
country: United States
facility: KGL Skin Study Center
state: Pennsylvania
city: Hershey
country: United States
facility: Department of Dermatology, UPCII
state: Pennsylvania
city: Arlington
country: United States
facility: Arlington Research Center, Inc.
state: Texas
city: Austin
country: United States
facility: DermResearch, LLC
state: Texas
city: Houston
country: United States
facility: University of Texas Medical School at Houston
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research, Inc.
state: Texas
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
Study officials:
affiliation: Allergan
name: Cathy Truong
role: STUDY_DIRECTOR
References: