Phase 4
Completed N=100
Safety and Efficacy Trial of ACZONE (Dapsone) Gel, 7.5% in 9 to 11 Year-Old Patients With Acne Vulgaris
Source: ClinicalTrials.gov NCT02959970 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcomePrimary: Number of Participants With Adverse Events (AE) — 5; 16 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AE) |
5; 16 | — |
| PRIMARY Change From Baseline in Systolic and Diastolic Blood Pressure |
3.9; 0.1; 2.3; 0.4 | — |
| PRIMARY Change From Baseline in Heart Rate |
-0.8; 0.6 | — |
| PRIMARY Change From Baseline in Respiratory Rate |
0.5; -0.1 | — |
| PRIMARY Change From Baseline in Body Temperature |
0.08; 0.10 | — |
| PRIMARY Change From Baseline in Weight |
0.70; 1.48 | — |
| PRIMARY Change From Baseline in Height |
0.21; 1.01 | — |
| PRIMARY Local Dermal Tolerability: Number of Participants With Dryness, Scaling and Erythema as Assessed by Investigator |
15; 71; 0; 6; 0; 0 | — |
| PRIMARY Local Dermal Tolerability: Number of Participants With Stinging/Burning Symptoms as Assessed by Participants |
15; 75; 0; 2; 0; 0 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02959970). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.