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

NCT ID: NCT07237763

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-15
• Study Completion Date: 2025-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

mild acne patients who will apply topical adapalene 2%

they will apply topical retinoid cream once daily at night on the whole face except sensitive areas for a period of 12 weeks

Group Type: ACTIVE_COMPARATOR

topical adapalene to the face

Intervention Type: DRUG

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

mild acne patients who will apply topical ketoconazole 2%

they will apply topical KTZ 2% cream twice daily on the whole face for 12 weeks

Group Type: ACTIVE_COMPARATOR

advised to apply topical ketoconazole 2% cream twice daily on the whole face.

Intervention Type: DRUG

ketoconazole will be applied twice per day on the face for 12 weeks

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients with mild comedonal or papulopustular acne with a GEA score from 1-2 on the face.
• Both sexes.
• Age: adolescents and adults.
• Skin type 3 and 4.

Exclusion Criteria

• • Patients using, will use during the study, or discontinued less than 4 weeks before study baseline, prescribed or over-the counter topical therapies for the treatment of acne.

• Patients using, will use during the study, or discontinued less than 4 weeks before study baseline, any facial procedures such as chemical peel, laser treatment or depilation in area of treatment application (except eyebrow shaping).
• Patients with outdoor occupation, exposed to sun and heat.
• Patients using, will use during study any cosmoceuticals.
• Patients using, will use during the study, or discontinued less than 12 weeks before study baseline, systemic therapies for the treatment of acne or any other systemic treatments.
• Patients with other special types of acne or conditions presenting with acne/acneiform eruption.
• Irregular menstrual cycles or clinically suspected polycystic ovarian syndrome.
• Patients with other facial rashes preventing the accurate assessment.
• Known or suspected allergy to ingredients.
• Pregnancy or lactation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mona Mostafa Korany Mahmoud

lecturer of dermatology, Cairo university

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo university

Cairo, , Egypt

Countries

Egypt

Other Identifiers

Dermatology 25

Identifier Type: -

Identifier Source: org_study_id