Acne
Conditions
Keywords
ketoconazole, adapalene
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.
Interventions
DRUGadvised 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
DRUGtopical 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
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To study the efficacy of topical ketoconazole 2% cream in treatment of mild to moderate acne | 3 months | results will be assessed using total lesion count |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| patient satisfaction | 3 months | evaluation will be on a scale from 1-10 |
| effect on post inflammatory hyperpigemntation | 3 month | by a subjective score ranging from mild to severe |
Countries
Egypt
Outcome results
None listed