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

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

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.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: dapsone gel

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Kirklin Clinic
  • California
    • Fremont, California, United States, 94538
      • Center for Dermatology Clinical Research
    • Northridge, California, United States, 91324
      • Quest Dermatology Research
    • Santa Ana, California, United States, 92701
      • Southern California Dermatology
    • Santa Rosa, California, United States, 95401
      • Redwood Family Dermatology
  • Florida
    • Aventura, Florida, United States, 33180
      • Center for Clinical and Cosmetic Research
    • Miami Beach, Florida, United States, 33137
      • Baumann Cosmetic and Research Institute
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • DermResearch, PLLC
  • Michigan
    • Fort Gratiot, Michigan, United States, 48059
      • Hamzavi Dermatology
  • Missouri
    • Saint Louis, Missouri, United States, 63104
      • Saint Louis University Dermatology
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Skin Specialists, PC
  • New York
    • New York, New York, United States, 10155
      • Skin Specialty Dermatology
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27106
      • Health Sciences/Department of Dermatology
  • Pennsylvania
    • Broomall, Pennsylvania, United States, 19008
      • Kgl Skin Study Center
    • Hershey, Pennsylvania, United States, 17033
      • Department of Dermatology, UPCII
  • Texas
    • Arlington, Texas, United States, 76011
      • Arlington Research Center, Inc.
    • Austin, Texas, United States, 78759
      • DermResearch, LLC
    • Houston, Texas, United States, 77030
      • University of Texas Medical School at Houston
    • Pflugerville, Texas, United States, 78660
      • Austin Institute for Clinical Research, Inc.
  • Washington
    • Spokane, Washington, United States, 99202
      • Premier Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 9 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PK Cohort: ACZONE 7.5%; 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; Dapsone (ACZONE) 7.5% gel topically once daily.; Other Names: ACZONE
Experimental: Non-PK Cohort: ACZONE 7.5%; 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; Dapsone (ACZONE) 7.5% gel topically once daily.; Other Names: ACZONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Plasma Concentration of Dapsone,Dapsone Hydroxylamine and N-acetyl Dapsone at Week 1	The mean plasma peak (10 hours postdose) concentrations of dapsone, dapsone hydroxylamine and N-acetyl dapsone were reported.	Week 1 (Pre-dose and 10 hours post-dose)
Trough Plasma Concentration of Dapsone, Dapsone Hydroxylamine and N-acetyl Dapsone at Week 1	The trough plasma concentrations of Dapsone, Dapsone hydroxylamine and N-acetyl dapsone were reported.	Week 1 (Pre-dose)
Absolute Change From Baseline in Inflammatory Lesion Counts	Inflammatory lesion counts were the sum of counts of the following lesion types (face only): Papule - a small, red, solid elevation less than (<) 1.0 centimeter (cm) in diameter; Pustule - a small, circumscribed elevation of the skin that contains yellow-white exudate; Nodule - a circumscribed, elevated, solid lesion generally more than 1.0 cm in diameter with palpable depth; Cyst - a smooth, dome-shaped, elevated, freely moveable, skin-colored, round to ovoid lesion greater than 0.7 cm in diameter. Change from baseline was calculated by subtracting post-dose value from baseline value.	Baseline (Day 1), Week 12
Percent Change From Baseline in Inflammatory Lesion Counts	Inflammatory lesion counts were the sum of counts of the following lesion types (face only): Papule - a small, red, solid elevation less than 1.0 cm in diameter; Pustule - a small, circumscribed elevation of the skin that contains yellow-white exudate; Nodule - a circumscribed, elevated, solid lesion generally more than 1.0 cm in diameter with palpable depth; Cyst - a smooth, dome-shaped, elevated, freely moveable, skin colored, round to ovoid lesion greater than 0.7 cm in diameter.	Baseline (Day 1), Week 12
Absolute Change From Baseline in Non-inflammatory Lesion Counts	Non-inflammatory lesion counts were defined as the sum of counts of the following lesion type (face only): open comedone - a pigmented dilated pilosebaceous orifice (blackhead); closed comedone - a tiny white papule (whitehead). Change from baseline was be calculated by subtracting post-dose value from the baseline value.	Baseline (Day 1), Week 12
Percent Change From Baseline in Non-inflammatory Lesion Counts	Noninflammatory lesion counts were defined as the sum of counts of the following lesion type (face only): open comedone - a pigmented dilated pilosebaceous orifice (blackhead); closed comedone - a tiny white papule (whitehead).	Baseline (Day 1), Week 12
Absolute Change From Baseline in Total Lesion Counts on Face	Total lesion counts were defined as the sum of inflammatory lesion counts and noninflammatory lesion counts (face only). Change from baseline was be calculated by subtracting post-dose value from the baseline value.	Baseline (Day 1), Week 12
Percent Change From Baseline in Total Lesion Counts on Face	Total lesion counts were defined as the sum of inflammatory lesion counts and noninflammatory lesion counts (face only).	Baseline (Day 1), Week 12
Percentage of Participants With None (0) or Minimal (1) Score on the Investigator's Global Assessment (IGA) for Face	Overall severity of acne vulgaris was evaluated by using a 5-point IGA scale: Clear (0) - (no comedones; papules or pustules, residual hyperpigmentation and erythema may be present); Almost clear (1) - (rare comedones; no more than a few small papules and pustules); Mild (2) - (easily recognizable comedones in limited numbers; +/- presence of small papules and pustules); Moderate (3) - (many comedones; +/- easily recognizable small and medium-sized papules; no nodules or cysts; Severe (4) - (widespread and numerous comedones; many small, medium-sized and large papules and pustules; nodules or cysts may or may not be present).	Week 12
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	Overall severity of acne vulgaris was evaluated by using a 5-point IGA scale: Clear (0) - (no comedones; papules or pustules, residual hyperpigmentation and erythema may be present); Almost clear (1) - (rare comedones; no more than a few small papules and pustules); Mild (2) - (easily recognizable comedones in limited numbers; +/- presence of small papules and pustules); Moderate (3) - (many comedones; +/- easily recognizable small and medium-sized papules; no nodules or cysts; Severe (4) - (widespread and numerous comedones; many small, medium-sized and large papules and pustules; nodules or cysts may or may not be present).	Week 12

Collaborators and Investigators

• Sponsor: Almirall, S.A.
• Collaborators: Allergan
• Investigators: Study Director: Cathy Truong, Allergan

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2016
• Primary Completion (Actual): March 9, 2018
• Study Completion (Actual): March 9, 2018

Study Registration Dates

• First Submitted: November 7, 2016
• First Submitted That Met QC Criteria: November 7, 2016
• First Posted (Estimate): November 9, 2016

Study Record Updates

• Last Update Posted (Actual): March 3, 2020
• Last Update Submitted That Met QC Criteria: February 19, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Leprostatic Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Folic Acid Antagonists; Dapsone
• Other Study ID Numbers: 1679-401-006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No