A study of the effectiveness of maintenance treatment with adapalene 0.1%-benzoyl peroxide 2.5% gel and benzoyl peroxide 2.5% gel in acne vulgaris patients
- Conditions
- Acne vulgaris
- Registration Number
- JPRN-jRCTs051200035
- Lead Sponsor
- Tanizaki Hideaki
- Brief Summary
Both adapalene/benzoyl peroxide (A) group and benzoyl peroxide (B) group showed significant treatment success rates compared with control group, which showed the efficacy of treatment A and B for patients with acne vulgaris. Major non-conformances were found in 11 patients, however, equivalent results were obtained both in PPS and FAS analysis, which indicated the robustness of the results. No significant adverse events were found both in group A and B, which showed no major safety issues.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 126
1) Patients diagnosed with acne vulgaris
2) Patients with 10 or fewer inflammatory lesions on full face due to acute inflammatory treatment within 3 months (12 weeks, allowance; + 1 week) prior to written informed consent
3) Patients with 10 or more and less than 100 atrophic scars (diameter 0.5 mm or more) at informed consent obtained.
4) Patients are 20 years old or more at the time of written consent
5) Patients are written informed consent with participation in this study
* Inclusion criteria is regardless of the severity at the first visit and the drug used in the acute inflammation phase.
1) Patients who are taking Tranilast by oral within 3 months prior to written informed consent
2) Patients with any history of hypersensitivity to adapalene-benzoyl peroxide or benzoyl peroxide components
3) Pregnant or possibly pregnant women, lactating women
4) Women who wanted to become pregnant during the study period
5) Patients judged as ineligible for participation in this study by the investigator
6) Patients participated in another clinical study of other medicine(s) for acne vulgaris within 6 months before written informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Treatment success rate (Percentage of patients 10 or fewer inflammatory lesions on full face throughout observation period)
- Secondary Outcome Measures
Name Time Method 1) Periods of used externally or oral antibiotics<br>2) Change in the number of the acne scars<br>3) Changes in the severity of the acne scars (Global Severity of Atrophic Acne Scar GSAAS)<br>4) Changes in the Antera 3D parameters (Affected area (mm2) ,Volume (mm3) ,Max depth (mm))<br>5) Change in the number of skin rashes (Number of inflammatory lesions, Number of non-inflammatory lesions, Number of total lesions)