Phase 4
Completed N=20
Efficacy and Safety of Aczone 7.5% Gel in the Treatment of Truncal Acne Vulgaris
Source: ClinicalTrials.gov NCT02944461 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcomePrimary: Percent of Subjects Who Achieve at Least a Two Grade Improvement and a Rating of Clear or Almost Clear on the Investigator Global Assessment (IGA) Scale — 0; 3; 7 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 This can indicate results are unpublished — a known publication-bias signal.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
To determine if Dapsone (Aczone) 7.5% gel is a safe and effective treatment for acne on the trunk
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Subjects Who Achieve at Least a Two Grade Improvement and a Rating of Clear or Almost Clear on the Investigator Global Assessment (IGA) Scale |
0; 3; 7 | — |
| SECONDARY The Percent Change in Inflammatory Lesion Count at Week 16 Compared to Baseline |
-74 | — |
| SECONDARY The Percent Change in Non-inflammatory Lesion Count at Week 16 Compared to Baseline |
-72 | — |
| SECONDARY The Percent Change in Total Lesion Count at Week 16 Compared to Baseline |
-73 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female subjects of any race and at least 12 years of age.
- Female subjects of childbearing potential must have a negative urine pregnancy test at Baseline and practice a reliable method of contraception throughout the study.
- Truncal acne IGA score of 3.
- Able to understand the requirements of study and sign Informed Consent/HIPAA forms.
Exclusion Criteria
- Female subjects who are pregnant , breast feeding or are of childbearing potential who are not willing to use a reliable method birth control.
- Subjects who have an allergy or sensitivity to any component of the test medication.
- Subjects who have not complied with the proper wash out periods for prohibited medications.
- Evidence of recent drug or alcohol abuse.
- Skin disease /disorder that might interfere with the diagnosis or evaluation of truncal acne.
- Exposure to an investigational drug within 30 days of the Baseline visit.
- Medical condition that contraindicates the subject's participation in the study.
- History of poor cooperation, non-compliance with medical treatment or unreliability.
Data sourced from ClinicalTrials.gov (NCT02944461). 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.