Safety and Efficacy Trial of ACZONE (Dapsone) Gel, 7.5% in 9 to 11 Year-Old Patients With Acne Vulgaris

NCT02959970 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 1679-401-006
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 20

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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (9)

• Number of Participants With Adverse Events (AE)

  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.

  From Baseline (Day 1) until Week 12

• Change From Baseline in Systolic and Diastolic Blood Pressure

  Change from baseline in systolic and diastolic blood pressure was evaluated. Change from baseline was calculated by subtracting post-dose value from baseline value.

  Baseline (Day 1), Week 12

• Change From Baseline in Heart Rate

  Change from baseline in heart rate was evaluated. Change from baseline was calculated by subtracting post-dose value from baseline value.

  Baseline (Day 1), Week 12

• Change From Baseline in Respiratory Rate

  Change from baseline in respiratory rate was assessed. Change from baseline was calculated by subtracting post-dose value from baseline value.

  Baseline (Day 1), Week 12

• Change From Baseline in Body Temperature

  Change from baseline in body temperature was assessed. Change from baseline was calculated by subtracting post-dose value from baseline value.

  Baseline (Day 1), Week 12

• Change From Baseline in Weight

  Change from baseline in weight was assessed. Change from baseline was calculated by subtracting post-dose value from baseline value.

  Baseline (Day 1), Week 12

• Change From Baseline in Height

  Change from baseline in height was assessed. Change from baseline was calculated by subtracting post-dose value from baseline value.

  Baseline (Day 1), Week 12

• Local Dermal Tolerability: Number of Participants With Dryness, Scaling and Erythema as Assessed by Investigator

  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.

  Week 12

• Local Dermal Tolerability: Number of Participants With Stinging/Burning Symptoms as Assessed by Participants

  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.

  Week 12

Other Outcomes (10)

• Peak Plasma Concentration of Dapsone,Dapsone Hydroxylamine and N-acetyl Dapsone at Week 1

  Week 1 (Pre-dose and 10 hours post-dose)

• Trough Plasma Concentration of Dapsone, Dapsone Hydroxylamine and N-acetyl Dapsone at Week 1

  Week 1 (Pre-dose)

• Absolute Change From Baseline in Inflammatory Lesion Counts

  Baseline (Day 1), Week 12

Study Arms (2)

PK Cohort: ACZONE 7.5%

EXPERIMENTAL

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.

Drug: dapsone gel

Non-PK Cohort: ACZONE 7.5%

EXPERIMENTAL

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.

Drug: dapsone gel

Interventions

dapsone gel DRUG

Dapsone (ACZONE) 7.5% gel topically once daily.

Also known as: ACZONE

Non-PK Cohort: ACZONE 7.5%; PK Cohort: ACZONE 7.5%

Eligibility Criteria

• Age: 9 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Almirall, S.A.: lead
• Allergan: collaborator

Study Sites (20)

Kirklin Clinic

Birmingham, Alabama, 35233, United States

Location

Center for Dermatology Clinical Research

Fremont, California, 94538, United States

Location

Quest Dermatology Research

Northridge, California, 91324, United States

Location

Southern California Dermatology

Santa Ana, California, 92701, United States

Location

Redwood Family Dermatology

Santa Rosa, California, 95401, United States

Location

Center for Clinical and Cosmetic Research

Aventura, Florida, 33180, United States

Location

Baumann Cosmetic and Research Institute

Miami Beach, Florida, 33137, United States

Location

Dermresearch, PLLC

Louisville, Kentucky, 40217, United States

Location

Hamzavi Dermatology

Fort Gratiot, Michigan, 48059, United States

Location

Saint Louis University Dermatology

St Louis, Missouri, 63104, United States

Location

Skin Specialists, PC

Omaha, Nebraska, 68144, United States

Location

Skin Specialty Dermatology

New York, New York, 10155, United States

Location

Health Sciences/Department of Dermatology

Winston-Salem, North Carolina, 27106, United States

Location

KGL Skin Study Center

Broomall, Pennsylvania, 19008, United States

Location

Department of Dermatology, UPCII

Hershey, Pennsylvania, 17033, United States

Location

Arlington Research Center, Inc.

Arlington, Texas, 76011, United States

Location

DermResearch, LLC

Austin, Texas, 78759, United States

Location

University of Texas Medical School at Houston

Houston, Texas, 77030, United States

Location

Austin Institute for Clinical Research, Inc.

Pflugerville, Texas, 78660, United States

Location

Premier Clinical Research

Spokane, Washington, 99202, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Dapsone

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals

Results Point of Contact

• Title: Ayman Grada
• Organization: Almirall LLC

ayman.grada@almirall.com

610-840-7107

Study Officials

• Cathy Truong

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2016
• First Posted: November 9, 2016
• Study Start: October 31, 2016
• Primary Completion: March 9, 2018
• Study Completion: March 9, 2018
• Last Updated: March 3, 2020
• Results First Posted: February 13, 2020

Record last verified: 2020-02

Locations

US (20)