Comedone Extraction and Oral Doxycycline In The First Line Treatment of Moderate Acne Vulgaris
Keywords
Abstract
Description
Acne vulgaris (AV) is a polymorphic disease, characterized by inflammatory and noninflammatory lesions. Systemic antibiotics play a role as the first line therapy of moderate acne vulgaris treatment. Since bacterial resistance tends to increase, alternative therapy for moderate acne vulgaris is needed.
This study aims to evaluate the effectiveness of comedone extraction compared to oral antibiotics as the main therapy of moderate acne vulgaris; and to etermine the expression of HIF-1 alpha by examining the immunohistochemistry and ELISA as a sign of hypoxia/anoxia in MAV lesion.
This was a randomized, placebo-controlled clinical trial that was performed in 2015 at three different dermatology clinics in Indonesia, Cipto Mangunkusumo Hospital Jakarta, Gatot Soebroto Army Hospital Jakarta, and PT. Mattel Indonesia, Cikarang.
One hundred and twenty eight subjects, aged between 15 and 50 years, with moderate acne vulgaris were recruited and randomized to receive either oral doxycycline (100 mg) or comedone extraction for six weeks. Subjects who had acne lesion and the back area were offered skin lesion biopsy to evaluate immunohistochemistry and ELISA before administration of medication.
At each follow-up visit, subjects were asked to grade the overall response and questioned regarding adverse events. The objective or main outcome was total reduction of inflammatory and noninflammatory lesions.
Dates
| Last Verified: | 11/30/2019 |
| First Submitted: | 12/16/2019 |
| Estimated Enrollment Submitted: | 12/18/2019 |
| First Posted: | 12/19/2019 |
| Last Update Submitted: | 12/18/2019 |
| Last Update Posted: | 12/19/2019 |
| Actual Study Start Date: | 03/31/2015 |
| Estimated Primary Completion Date: | 09/29/2015 |
| Estimated Study Completion Date: | 10/13/2015 |
Condition or disease
Intervention/treatment
Drug: Doxycycline Group
Procedure: Comedone Extraction Group
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Placebo Comparator: Doxycycline Group Subjects were randomized to receive Doxycycline capsules. The capsules were taken once daily for 6 weeks and evaluated every 2 weeks. | Drug: Doxycycline Group Doxycycline capsule 100 mg/day, tretinoin cream 0.05% on face every night, benzoyl peroxide gel 2.5% on face in the morning and afternoon. |
| Active Comparator: Comedone Extraction Group Subjects were randomized to receive comedone extraction. Comedone extraction were done three times, and evaluated every 2 weeks. | Procedure: Comedone Extraction Group Comedone extraction, tretinoin cream 0.05% on face every night, benzoyl peroxide gel 2.5% on face in the morning and afternoon. |
Eligibility Criteria
| Ages Eligible for Study | 15 Years To 15 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - Patients with moderate acne vulgaris based on clinical manifestation of face (20-100 comedones, 15-50 inflammatory lesions, and/or 30-125 total lesions) - Age range of 15 to 50 years old Exclusion Criteria: - History of oral antibiotics consumption within 2 weeks preceding this study - Usage of topical retinoid in less than previous 2 weeks - History of systemic retinoid consumption within 3 months preceding this study - Pregnant of breastfeeding women - Consuming oral contraception during examination - Drug allergy or skin manifestation due to side effect of moderate acne vulgaris first line therapy |
Outcome
Primary Outcome Measures
1. Change from Baseline Inflammatory Lesions at 2 weeks [2 weeks]
2. Change from Baseline Inflammatory Lesions at 4 weeks [4 weeks]
3. Change from Baseline Inflammatory Lesions at 6 weeks [6 weeks]
4. Change from Baseline Non-Inflammatory Lesions at 2 weeks [2 weeks]
5. Change from Baseline Non-Inflammatory Lesions at 4 weeks [4 weeks]
6. Change from Baseline Non-Inflammatory Lesions at 6 weeks [6 weeks]
Secondary Outcome Measures
1. Subjective Improvement at 2 weeks [2 weeks]
2. Subjective Improvement at 4 weeks [4 weeks]
3. Subjective Improvement at 6 weeks [6 weeks]
4. Number of Participants with Side Effects at 2 weeks [2 weeks]
5. Number of Participants with Side Effects at 4 weeks [4 weeks]
6. Number of Participants with Side Effects at 6 weeks [6 weeks]
Other Outcome Measures
1. Expression of Antibody HIF-1 Alpha with Immunohistochemistry Examination [Baseline]
2. Expression of Antibody HIF-1 Alpha with ELISA Examination [Baseline]
