The Study of Efficacy and Safety of 2% Ketoconazole Cream in Thai Females With Mild Degree of Post - Adolescence Acne

Chulalongkorn University

Status and phase: Completed; Phase 3

Conditions: Post - Adolescence Acne

Treatments: Drug: 2% ketoconazole cream; Drug: Hydrophilic Cream

Study type: Interventional

Funder types: Other

Identifiers

NCT03178994

317/60

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: Female

Ages: 25 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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42 participants in 2 patient groups, including a placebo group

2% ketoconazole cream

Experimental group

Description:

2% ketoconazole cream apply on face twice daily for 10 weeks.

Treatment:

Drug: 2% ketoconazole cream

Placebo

Placebo Comparator group

Description:

Hydrophilic cream (in-house preparation) apply on face twice daily for 10 weeks.

Treatment:

Drug: Hydrophilic Cream