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The goal of this clinical trial is to compare the effectiveness, safety profile, and post-acne sequelae of 0.025% retinoic acid cream versus 0.1% adapalene cream for mild acne vulgaris in individuals with Fitzpatrick skin types III-V.
Main research questions are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with 0.025% Retinoic Acid Cream (Split-Face Design) | Experimental | Participants will apply 0.025% retinoic acid cream half finger tip unit on one randomized side of the face every night for 12 weeks. |
|
| Treatment with 0.1% Adapalene Cream (Split-Face Design) | Experimental | Participants will apply 0.1% adapalene cream half finger tip unit on one randomized side of the face every night for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| retinoic acid cream 0.025% | Drug | half finger tip unit |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the percentage reduction in total acne lesions between the 0.025% tretinoin cream group and the 0.1% adapalene cream group | The percentage reduction was calculated by comparing the total number of lesions at 12 weeks to baseline counts | from enrollment to the end of treatment at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Severity profile of adverse effects | Mild: presence of subjective symptoms such as itching or burning sensation without any objective signs (e.g., erythema or desquamation); Moderate: presence of both subjective symptoms and objective signs, but not interfering with daily activities or treatment adherence; Severe: presence of subjective and objective signs that are bothersome and interfere with the patient's comfort or treatment adherence The proportion for each severity grade will be presented as a percentage. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cipto Mangunkusumo National Hospital | Jakarta | DKI Jakarta | 10430 | Indonesia |
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| adapalene cream 0.1% | Drug | half finger tip unit |
|
| from enrollment to the end of treatment at 12 weeks |
| Hyperpigmentation index profile | The hyperpigmentation index was calculated by multiplying the intensity score of each lesion-assessed using the Taylor Hyperpigmentation Scale-by the total number of lesions. The final index was obtained by averaging the results across all affected sites. The minimum possible score is 0, and the maximum score is 9. A higher score indicates more severe post-acne hyperpigmentation experienced by the study subjects. | from enrollment to the end of treatment at 12 weeks |
| Post acne erythema profile | Post-acne erythema was assessed using the Clinician Erythema Assessment (CEA) scale, which grades erythema severity into five categories: clear, almost clear, mild, moderate, and severe. The proportion for each severity grade will be presented as a percentage. | from enrollment to the end of treatment at 12 weeks |
| Profile of post-acne scar type | The types of post-acne scars recorded included icepick, rolling, boxcar, hypertrophic, keloid, and papular scars. The proportion of each scar type was calculated and will be presented as percentage. | from enrollment to the end of treatment at 12 weeks |
| Severity profile of post acne scarring | Additionally, the severity of post-acne scarring was graded as macular, mild, moderate, or severe based on clinical evaluation. The proportion for each grade will be presented as a percentage. | from enrollment to the end of treatment at 12 weeks |
| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| D017495 | Hyperpigmentation |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
| D010859 | Pigmentation Disorders |
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