Acne vulgaris
Conditions
Interventions
Phase I Group A: BPO gel + Clindamycin product (Concomitant therapy group)
Phase I Group B: BPO gel +Adapalene gel (Concomitant therapy group)
Phase I Group C: Adapalene gel +Clindamycin produc
Sponsors
Non-Profit Organization Health Institute Research of Skin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Phase I 1) Patients with moderate or severe acne vulgaris (6 to 30 inflammatory rashes on the right or left half of the face) 2) Patients who provided written informed consent after receiving an explanation of the details of the study 3) Patients aged 16 years old or older at the time informed consent was provided For patients younger than 20 years old, representatives (parents, etc.) are required to provide informed consent. Phase II 1) Patients in whom inflammatory rashes were reduced to 5 or less on the face and 3 or less on the right or left half of the face within 12 weeks from commencement of phase I (acute phase) treatment 2) Patients who provided written informed consent after receiving another explanation of the details of the study in the maintenance period
Exclusion criteria
Exclusion criteria: Phase I 1) Patients who had received treatment for acne vulgaris within one month of the start of the study 2) Patients in whom the study drug is contraindicated 3) Patients with continuous use of non-steroidal anti-inflammatory drugs (ibuprofen, etc.) 4) Pregnant women, those who may be pregnant, lactating women, and women who hope to become pregnant during the study period 5) Patients who were considered inappropriate for the study by an investigator 6) Patients who had participated in other clinical studies and phase IV clinical trials of drugs for acne vulgaris within 6 months of the start of the study Phase II 1) Patients who were cons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PhaseI: Decrease in the number of inflammatory rashes / during 12 weeks of observation period PhaseII:Symptom maintenance period / period until development or increase of inflammatory rash) / during 12 weeks of observation period | — |
Countries
Japan
Contacts
Public ContactNaomi Kanazawa
EBC&M LLC. Project planning & Development department
Outcome results
None listed