Post - Adolescence Acne Clinical Trial
Official title:
The Study of Efficacy and Safety of 2% Ketoconazole Cream in Thai Females With Mild Degree of Post - Adolescence Acne
| Verified date | July 2018 |
| Source | Chulalongkorn University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
To study efficacy (total numbers of acne reduction) and safety of 2% Ketoconazole cream in Thai females with Mild degree Post-Adolescence acne comparing with placebo for a period of 12 weeks.
| Status | Completed |
| Enrollment | 42 |
| Est. completion date | December 30, 2018 |
| Est. primary completion date | September 15, 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 25 Years to 50 Years |
| Eligibility |
Inclusion Criteria: - regular menstrual cycle with mild degree of post - adolescence acne - agree to stop topical and systemic medication for acne treatment for 2 and 4 weeks respectively. Exclusion Criteria: - Pregnancy or lactation - Other active rashes on faces. - Allergic to ketoconazole or other ingredients of preparation. - Signs of hyperandrogenism - Taking anti-androgenic medications. |
| Country | Name | City | State |
|---|---|---|---|
| Thailand | Department of Medicine, Faculty of Medicine, Chulalongkorn University | Bangkok |
| Lead Sponsor | Collaborator |
|---|---|
| Chulalongkorn University |
Thailand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Total numbers of acne reduction | the difference of acne count (total numbers of acne before treatment - total numbers of acne after treatment) | 10 weeks | |
| Secondary | Proportion of patients who achieve clear or almost clear after treatment | clear or almost clear scored by Adult Female Acne Scoring Tool | 10 weeks |