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

Cairo University (CU)

Status

Active, not recruiting

Conditions

Acne

Treatments

Drug: topical adapalene to the face

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

Study type

Interventional

Funder types

Other

Identifiers

NCT07237763

Dermatology 25

Details and patient eligibility

About

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

Full 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.

Enrollment

52 estimated patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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.