The Study of Efficacy and Safety of 2% Ketoconazole Cream in Thai Females With Mild Degree of Post - Adolescence Acne
Phase 3
Completed
- Conditions
- Post - Adolescence Acne
- Interventions
- Drug: Hydrophilic Cream
- Registration Number
- NCT03178994
- Lead Sponsor
- Chulalongkorn University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 42
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2% ketoconazole cream 2% ketoconazole cream 2% ketoconazole cream apply on face twice daily for 10 weeks. Placebo Hydrophilic Cream Hydrophilic cream (in-house preparation) apply on face twice daily for 10 weeks.
- Primary Outcome Measures
Name Time Method Total numbers of acne reduction 10 weeks the difference of acne count (total numbers of acne before treatment - total numbers of acne after treatment)
- Secondary Outcome Measures
Name Time Method Proportion of patients who achieve clear or almost clear after treatment 10 weeks clear or almost clear scored by Adult Female Acne Scoring Tool
Trial Locations
- Locations (1)
Department of Medicine, Faculty of Medicine, Chulalongkorn University
🇹🇭Bangkok, Thailand