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

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ClinicalTrials.gov Identifier: NCT02959970
Recruitment Status : Completed
First Posted : November 9, 2016
Results First Posted : February 13, 2020
Last Update Posted : March 3, 2020
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Almirall, S.A.

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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: dapsone gel Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 31, 2016
Actual Primary Completion Date : March 9, 2018
Actual Study Completion Date : March 9, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne
Drug Information available for: Dapsone

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 Name: 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 Name: ACZONE




Primary Outcome Measures :
  1. Number of Participants With Adverse Events (AE) [ Time Frame: From Baseline (Day 1) until Week 12 ]
    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.

  2. Change From Baseline in Systolic and Diastolic Blood Pressure [ Time Frame: Baseline (Day 1), Week 12 ]
    Change from baseline in systolic and diastolic blood pressure was evaluated. Change from baseline was calculated by subtracting post-dose value from baseline value.

  3. Change From Baseline in Heart Rate [ Time Frame: Baseline (Day 1), Week 12 ]
    Change from baseline in heart rate was evaluated. Change from baseline was calculated by subtracting post-dose value from baseline value.

  4. Change From Baseline in Respiratory Rate [ Time Frame: Baseline (Day 1), Week 12 ]
    Change from baseline in respiratory rate was assessed. Change from baseline was calculated by subtracting post-dose value from baseline value.

  5. Change From Baseline in Body Temperature [ Time Frame: Baseline (Day 1), Week 12 ]
    Change from baseline in body temperature was assessed. Change from baseline was calculated by subtracting post-dose value from baseline value.

  6. Change From Baseline in Weight [ Time Frame: Baseline (Day 1), Week 12 ]
    Change from baseline in weight was assessed. Change from baseline was calculated by subtracting post-dose value from baseline value.

  7. Change From Baseline in Height [ Time Frame: Baseline (Day 1), Week 12 ]
    Change from baseline in height was assessed. Change from baseline was calculated by subtracting post-dose value from baseline value.

  8. Local Dermal Tolerability: Number of Participants With Dryness, Scaling and Erythema as Assessed by Investigator [ Time Frame: Week 12 ]
    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.

  9. Local Dermal Tolerability: Number of Participants With Stinging/Burning Symptoms as Assessed by Participants [ Time Frame: Week 12 ]
    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.


Other Outcome Measures:
  1. Peak Plasma Concentration of Dapsone,Dapsone Hydroxylamine and N-acetyl Dapsone at Week 1 [ Time Frame: Week 1 (Pre-dose and 10 hours post-dose) ]
    The mean plasma peak (10 hours postdose) concentrations of dapsone, dapsone hydroxylamine and N-acetyl dapsone were reported.

  2. Trough Plasma Concentration of Dapsone, Dapsone Hydroxylamine and N-acetyl Dapsone at Week 1 [ Time Frame: Week 1 (Pre-dose) ]
    The trough plasma concentrations of Dapsone, Dapsone hydroxylamine and N-acetyl dapsone were reported.

  3. Absolute Change From Baseline in Inflammatory Lesion Counts [ Time Frame: Baseline (Day 1), Week 12 ]
    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.

  4. Percent Change From Baseline in Inflammatory Lesion Counts [ Time Frame: Baseline (Day 1), Week 12 ]
    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.

  5. Absolute Change From Baseline in Non-inflammatory Lesion Counts [ Time Frame: Baseline (Day 1), Week 12 ]
    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.

  6. Percent Change From Baseline in Non-inflammatory Lesion Counts [ Time Frame: Baseline (Day 1), Week 12 ]
    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).

  7. Absolute Change From Baseline in Total Lesion Counts on Face [ Time Frame: Baseline (Day 1), Week 12 ]
    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.

  8. Percent Change From Baseline in Total Lesion Counts on Face [ Time Frame: Baseline (Day 1), Week 12 ]
    Total lesion counts were defined as the sum of inflammatory lesion counts and noninflammatory lesion counts (face only).

  9. Percentage of Participants With None (0) or Minimal (1) Score on the Investigator's Global Assessment (IGA) for Face [ Time Frame: Week 12 ]
    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).

  10. 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 [ Time Frame: Week 12 ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02959970


Locations
Show Show 20 study locations
Sponsors and Collaborators
Almirall, S.A.
Allergan
Investigators
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Study Director: Cathy Truong Allergan
  Study Documents (Full-Text)

Documents provided by Almirall, S.A.:
Study Protocol  [PDF] June 23, 2016
Statistical Analysis Plan  [PDF] May 10, 2018

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Responsible Party: Almirall, S.A.
ClinicalTrials.gov Identifier: NCT02959970    
Other Study ID Numbers: 1679-401-006
First Posted: November 9, 2016    Key Record Dates
Results First Posted: February 13, 2020
Last Update Posted: March 3, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Dapsone
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Anti-Bacterial Agents