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

NCT07237763 | Active Not Recruiting

• 1 other identifier: Dermatology 25
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Conditions

Acne

Keywords

ketoconazole; adapalene

Outcome Measures

Primary Outcomes (1)

• To study the efficacy of topical ketoconazole 2% cream in treatment of mild to moderate acne

  results will be assessed using total lesion count

  3 months

Secondary Outcomes (2)

• patient satisfaction

  3 months

• effect on post inflammatory hyperpigemntation

  3 month

Study Arms (2)

mild acne patients who will apply topical ketoconazole 2%

ACTIVE COMPARATOR

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

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

mild acne patients who will apply topical adapalene 2%

ACTIVE COMPARATOR

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

Drug: topical adapalene to the face

Interventions

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

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

mild acne patients who will apply topical ketoconazole 2%

topical adapalene to the face 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 adapalene 2%

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university

Cairo, Egypt

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of dermatology, Cairo university

Study Record Dates

• First Submitted: November 15, 2025
• First Posted: November 20, 2025
• Study Start: January 15, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)