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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| 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 |
| 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 |
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Inclusion Criteria:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo university | Cairo | Egypt |
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| 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 |
|
| 3 month |
| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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