NCT07237763

Assessment of the Efficacy of Topical Ketoconazole 2% Cream in Comparison With Topical Retinoids in the Treatment of Mild Comedonal and Papulopustular Acne

Comparison Between Topical Ketoconazole 2% Cream and Topical Adapalene 2% Cream in the Treatment of Mild Comedonal and Papulopustular Acne, a Randomized Controlled Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

objective: is to assess the efficacy of topical ketoconazole 2% cream in comparison with topical retinoid in the treatment of mild comedonal and papulopustular acne to determine if ketoconazole can be an alternative to topical retinoid with less side effects and more compliance. Patients and methods: 52 patients with mild comedonal and papulopustular acne will be randomized into 2 groups and instructed to apply randomly either topical KTZ 2% cream or topical retinoid cream for a period of 12 weeks. Evaluation of response will be done by a blinded investigator

Detailed description

Background: Acne vulgaris is a common chronic inflammatory skin disorder of pilosebaceous units that occurs predominantly in the skin of the face, upper chest and upper back. Acne is of multifactorial origin with four main pathophysiologic mechanisms: follicular hyperkeratinization with obstruction of pilosebaceous ducts, hormonal influences on sebum production, cutibacterium acnes (C. acnes) proliferation, immune host reaction and inflammation. Ketoconazole (KTZ) is an imidazolic anti-mycotic derivative that has been recently tried as a new line of treatment of mild acne. KTZ acts on microbial dysbiosis through the inhibitory effect on lipase activity of malassezia species and both antibiotic-susceptible and resistant C. acnes. Objectives: our objective is to assess the efficacy of topical ketoconazole 2% cream in comparison with topical retinoid in the treatment of mild comedonal and papulopustular acne to determine if ketoconazole can be an alternative to topical retinoid with less side effects and more compliance. Patients and methods: 52 patients with mild comedonal and papulopustular acne will be randomized into 2 groups. Group A will be advised to apply topical KTZ 2% cream twice daily on the whole face. Group B will be advised to apply topical retinoid cream once daily at night on the whole face except sensitive areas for a period of 12 weeks. Evaluation of response will be done by a blinded investigator 2 weeks after discontinuation of treatment using total lesion count, Global Evaluation of Acne (GEA) scores, Cardiff Acne Disability Index (CADI), and post-inflammatory hyperpigmentation (PIH) scores and patient satisfaction.

Conditions

• Acne

Interventions

Type	Name	Description
DRUG	advised to apply topical ketoconazole 2% cream twice daily on the whole face.	ketoconazole will be applied twice per day on the face for 12 weeks
DRUG	topical adapalene to the face	will be advised to apply topical adapalene cream once daily at night on the whole face except sensitive areas for a period of 12 weeks

Timeline

• Start date: 2024-01-15
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2025-11-20
• Last updated: 2025-11-20

Locations

1 site across 1 country: Egypt