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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Acne
• Intervention / Treatment: Drug: advised to apply topical ketoconazole 2% cream twice daily on the whole face.; Drug: topical adapalene to the face

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.

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	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
Active Comparator: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient satisfaction	evaluation will be on a scale from 1-10	3 months
effect on post inflammatory hyperpigemntation	by a subjective score ranging from mild to severe	3 month

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: November 15, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Actual): November 20, 2025

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: ketoconazole; adapalene
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Skin and Connective Tissue Diseases; Acne Vulgaris
• Other Study ID Numbers: Dermatology 25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No