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

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02959970
• Other study ID #: 1679-401-006
• Status: Completed
• Phase: Phase 4
• Start date: October 31, 2016
• Est. completion date: March 9, 2018

Study information

• Verified date: February 2020
• Source: Almirall, S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 9, 2018
• Est. primary completion date: March 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• dapsone gel
Dapsone (ACZONE) 7.5% gel topically once daily.

Locations

Country	Name	City	State
United States	Arlington Research Center, Inc.	Arlington	Texas
United States	DermResearch, LLC	Austin	Texas
United States	Center for Clinical and Cosmetic Research	Aventura	Florida
United States	Kirklin Clinic	Birmingham	Alabama
United States	KGL Skin Study Center	Broomall	Pennsylvania
United States	Hamzavi Dermatology	Fort Gratiot	Michigan
United States	Center for Dermatology Clinical Research	Fremont	California
United States	Department of Dermatology, UPCII	Hershey	Pennsylvania
United States	University of Texas Medical School at Houston	Houston	Texas
United States	Dermresearch, PLLC	Louisville	Kentucky
United States	Baumann Cosmetic and Research Institute	Miami Beach	Florida
United States	Skin Specialty Dermatology	New York	New York
United States	Quest Dermatology Research	Northridge	California
United States	Skin Specialists, PC	Omaha	Nebraska
United States	Austin Institute for Clinical Research, Inc.	Pflugerville	Texas
United States	Saint Louis University Dermatology	Saint Louis	Missouri
United States	Southern California Dermatology	Santa Ana	California
United States	Redwood Family Dermatology	Santa Rosa	California
United States	Premier Clinical Research	Spokane	Washington
United States	Health Sciences/Department of Dermatology	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Almirall, S.A.	Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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