A study of safety and efficacy of R410 for acne vulgaris.
- Conditions
- acne vulgaris
- Registration Number
- JPRN-UMIN000003617
- Lead Sponsor
- Rohto Pharmaceutical Co.,LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Not provided
1.Subjects with clinically-significant disorder that might influence the outcome of this study. 2.Acne conglobata, acne fulminans, or secondary acne (e.g. chloracne, drug-induced acne). 3.Subjects for whom the systemic treatment of acne vulgaris is necessary. 4.Underlying diseases or skin symptoms (e.g. atopic dermatitis, perioral dermatitis, rosacea), with topical or systemic treatment which could interfere with the study assesment. 5.History of hypersensitivity to any components of the study preparations. 6.Change in the use of facial cleanser or skin care products for acne within the past 1 month. 7.Use of the following items within the specified washout period or during the study. 7.1 Topical preparations and therapy applied to the sites to be studied 1)Topical preparations i)Use of the following preparations within the past 4 weeks. -Retinoids ii)Use of the following preparations within the past 2 weeks. -Benzoyl Peroxide -Corticosteroids -Exfoliating products including hydroxy acids, except facial cleanser 2)Therapy etc. i)Chemical peels, laser treatment, photo therapy, esthetic treatment, surgery of face. 7.2 Systemic drugs 1)Use of the following preparations within the past 12 weeks. -Retinoids 2)Use of the following preparations within the past 4 weeks. -Other acne treatments including antimicrobials etc. (except vitamin and cystein preparations) -Corticosteroids -Hormone preparations -Kampo preparations likely to be effective for acne 8.Subjects who are improper to entry this study, with some complications, e.g. severe heart disease, renal disorder, hepatic disorder, respiratory disease, cardiovascular disease, immune disorder. 9.Female who is pregnant, trying to become pregnant (self- declared), during this study period, or breast feeding. 10.Participation in another clinical study within the past 3 months. 11.Subjects who are improper as the participant in the study in judgement of the principal or the other investigators.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percent reduction of the total acne lesion counts
- Secondary Outcome Measures
Name Time Method -Percent reduction of the non-inflammatory lesion counts -Decrease percentage of the inflammatory lesion counts -Improvement level in the lesion counts -Safety: Adverse event -Assessment by subject