acne vulgaris
Conditions
Interventions
A preparation of R410 will be applied to the specified one-side face, in the morning and night after washing for 12 weeks.
A preparation of placebo will be applied to the other specified one-side face
Sponsors
Rohto Pharmaceutical Co.,LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Subjects with total acne (non-inflammatory and inflammatory) lesion more than 30 counts on the face (forehead, cheek, and jaw). - 10 to 40 inflammatory lesions - 20 non-inflammatory lesions or more - 2 nodules/cysts or less 2)Subjects with acne lesions on both sides of face which are almost the same severity. 3)Subjects who understood the requirements of the study and signed the informed consent forms.
Exclusion criteria
Exclusion criteria: 1.Subjects with clinically-significant disorder that might influence the outcome of this study on the face. 2.Acne conglobata, acne fulminans, or secondary acne. 3.Underlying diseases or skin symptoms, with topical or systemic treatment which could interfere with the study assesment. 4.History of hypersensitivity to any components of the study preparations. 5.Change in the use of facial cleanser or skin care products for acne within the past 1 month. 6.Subjects who administering or receiving therapy of the following items within the specified washout period or during the study. 6.1 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 (inclued adapalene, Vitamin A) containing products ii)Use of the following preparations within the past 2 weeks. -Benzoyl Peroxide -Corticosteroids -Exfoliating products 2)Receiving the following therapies within the past 4 weeks. i)Surgery of face, chemical peels, laser treatment, photo therapy, esthetic treatment. 6.2 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 (excepting topical dose such as nosal drop or eye drop) -Hormone preparations -Kampo preparations likely to be effective for acne 7.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. 8.Female who is pregnant, trying to become pregnant (self- declared), during this study period, or breast feeding. 9.Participation in another clinical study within the past 3 months. 10.Subjects who are improper as the participant in the study in judgement of the principal or the other investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent reduction of the total acne lesion counts | — |
Secondary
| Measure | Time frame |
|---|---|
| -Percent reduction of the non-inflammatory lesion counts -Decrease percentage of the inflammatory lesion counts -Improvement level in the lesion counts -Safety Additionally, the following items are also evaluated in subjects with post-inflammatory pigmentation induced by acne vulgaris. -visual evaluation of post-inflammatory pigmentation -Improvement level in the post-inflammatory pigmentation | — |
Countries
Japan
Outcome results
None listed