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

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
dapsone gel
Sponsored by
Almirall, S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

9 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kirklin Clinic
  • Center for Dermatology Clinical Research
  • Quest Dermatology Research
  • Southern California Dermatology
  • Redwood Family Dermatology
  • Center for Clinical and Cosmetic Research
  • Baumann Cosmetic and Research Institute
  • Dermresearch, PLLC
  • Hamzavi Dermatology
  • Saint Louis University Dermatology
  • Skin Specialists, PC
  • Skin Specialty Dermatology
  • Health Sciences/Department of Dermatology
  • KGL Skin Study Center
  • Department of Dermatology, UPCII
  • Arlington Research Center, Inc.
  • DermResearch, LLC
  • University of Texas Medical School at Houston
  • Austin Institute for Clinical Research, Inc.
  • Premier Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

PK Cohort: ACZONE 7.5%

Non-PK Cohort: ACZONE 7.5%

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 7, 2016
Last Updated
February 19, 2020
Sponsor
Almirall, S.A.
Collaborators
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT02959970
Brief Title
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

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
October 31, 2016 (Actual)
Primary Completion Date
March 9, 2018 (Actual)
Study Completion Date
March 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Almirall, S.A.
Collaborators
Allergan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PK Cohort: ACZONE 7.5%
Arm Type
Experimental
Arm Description
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.
Arm Title
Non-PK Cohort: ACZONE 7.5%
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
dapsone gel
Other Intervention Name(s)
ACZONE
Intervention Description
Dapsone (ACZONE) 7.5% gel topically once daily.
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events (AE)
Description
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.
Time Frame
From Baseline (Day 1) until Week 12
Title
Change From Baseline in Systolic and Diastolic Blood Pressure
Description
Change from baseline in systolic and diastolic blood pressure was evaluated. Change from baseline was calculated by subtracting post-dose value from baseline value.
Time Frame
Baseline (Day 1), Week 12
Title
Change From Baseline in Heart Rate
Description
Change from baseline in heart rate was evaluated. Change from baseline was calculated by subtracting post-dose value from baseline value.
Time Frame
Baseline (Day 1), Week 12
Title
Change From Baseline in Respiratory Rate
Description
Change from baseline in respiratory rate was assessed. Change from baseline was calculated by subtracting post-dose value from baseline value.
Time Frame
Baseline (Day 1), Week 12
Title
Change From Baseline in Body Temperature
Description
Change from baseline in body temperature was assessed. Change from baseline was calculated by subtracting post-dose value from baseline value.
Time Frame
Baseline (Day 1), Week 12
Title
Change From Baseline in Weight
Description
Change from baseline in weight was assessed. Change from baseline was calculated by subtracting post-dose value from baseline value.
Time Frame
Baseline (Day 1), Week 12
Title
Change From Baseline in Height
Description
Change from baseline in height was assessed. Change from baseline was calculated by subtracting post-dose value from baseline value.
Time Frame
Baseline (Day 1), Week 12
Title
Local Dermal Tolerability: Number of Participants With Dryness, Scaling and Erythema as Assessed by Investigator
Description
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.
Time Frame
Week 12
Title
Local Dermal Tolerability: Number of Participants With Stinging/Burning Symptoms as Assessed by Participants
Description
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.
Time Frame
Week 12
Other Pre-specified Outcome Measures:
Title
Peak Plasma Concentration of Dapsone,Dapsone Hydroxylamine and N-acetyl Dapsone at Week 1
Description
The mean plasma peak (10 hours postdose) concentrations of dapsone, dapsone hydroxylamine and N-acetyl dapsone were reported.
Time Frame
Week 1 (Pre-dose and 10 hours post-dose)
Title
Trough Plasma Concentration of Dapsone, Dapsone Hydroxylamine and N-acetyl Dapsone at Week 1
Description
The trough plasma concentrations of Dapsone, Dapsone hydroxylamine and N-acetyl dapsone were reported.
Time Frame
Week 1 (Pre-dose)
Title
Absolute Change From Baseline in Inflammatory Lesion Counts
Description
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.
Time Frame
Baseline (Day 1), Week 12
Title
Percent Change From Baseline in Inflammatory Lesion Counts
Description
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.
Time Frame
Baseline (Day 1), Week 12
Title
Absolute Change From Baseline in Non-inflammatory Lesion Counts
Description
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.
Time Frame
Baseline (Day 1), Week 12
Title
Percent Change From Baseline in Non-inflammatory Lesion Counts
Description
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).
Time Frame
Baseline (Day 1), Week 12
Title
Absolute Change From Baseline in Total Lesion Counts on Face
Description
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.
Time Frame
Baseline (Day 1), Week 12
Title
Percent Change From Baseline in Total Lesion Counts on Face
Description
Total lesion counts were defined as the sum of inflammatory lesion counts and noninflammatory lesion counts (face only).
Time Frame
Baseline (Day 1), Week 12
Title
Percentage of Participants With None (0) or Minimal (1) Score on the Investigator's Global Assessment (IGA) for Face
Description
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).
Time Frame
Week 12
Title
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
Description
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).
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cathy Truong
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Kirklin Clinic
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Center for Dermatology Clinical Research
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Quest Dermatology Research
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
Southern California Dermatology
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
Redwood Family Dermatology
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95401
Country
United States
Facility Name
Center for Clinical and Cosmetic Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Baumann Cosmetic and Research Institute
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
Facility Name
Dermresearch, PLLC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Hamzavi Dermatology
City
Fort Gratiot
State/Province
Michigan
ZIP/Postal Code
48059
Country
United States
Facility Name
Saint Louis University Dermatology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Skin Specialists, PC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Skin Specialty Dermatology
City
New York
State/Province
New York
ZIP/Postal Code
10155
Country
United States
Facility Name
Health Sciences/Department of Dermatology
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27106
Country
United States
Facility Name
KGL Skin Study Center
City
Broomall
State/Province
Pennsylvania
ZIP/Postal Code
19008
Country
United States
Facility Name
Department of Dermatology, UPCII
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Arlington Research Center, Inc.
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Facility Name
DermResearch, LLC
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
University of Texas Medical School at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Austin Institute for Clinical Research, Inc.
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Premier Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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