Comedone Extraction and Oral Doxycycline In The First Line Treatment of Moderate Acne Vulgaris

Study Overview
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Brief Summary
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The objective of the study was to evaluate the effectiveness of comedone extraction compared to oral antibiotics as the main therapy of moderate acne vulgaris (MAV); and to determine 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 with moderate acne vulgaris were recruited and randomized to receive either oral doxycycline 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. The main outcome was total reduction of inflammatory and non inflammatory lesions, evaluated every two weeks.

Detailed Description
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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.

Official Title
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Effectiveness of Comedone Extraction and Oral Doxycycline In The First Line Treatment of Moderate Acne Vulgaris: Study on HIF-1 Alpha Expression

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Doxycycline Capsule
* Procedure: Comedone extraction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Doxycycline Group<br>Subjects were randomized to receive Doxycycline capsules. The capsules were taken once daily for 6 weeks and evaluated every 2 weeks. | Drug: Doxycycline Capsule<br>* 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.<br>|
| Active Comparator: Comedone Extraction Group<br>Subjects were randomized to receive comedone extraction. Comedone extraction were done three times, and evaluated every 2 weeks. | Procedure: Comedone extraction<br>* Comedone extraction, tretinoin cream 0.05% on face every night, benzoyl peroxide gel 2.5% on face in the morning and afternoon.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Inflammatory Lesions at 2 weeks | Numeric data of total reduction (improvement) of inflammatory lesions (Baseline inflammatory lesion count) - (Week 2 inflammatory lesion count) __________________________________________________________ x 100% Baseline inflammatory lesion count | 2 weeks | 
| Change from Baseline Inflammatory Lesions at 4 weeks | Numeric data of total reduction (improvement) of inflammatory lesions (Baseline inflammatory lesion count) - (Week 4 inflammatory lesion count) __________________________________________________________ x 100% Baseline inflammatory lesion count | 4 weeks | 
| Change from Baseline Inflammatory Lesions at 6 weeks | Numeric data of total reduction (improvement) of inflammatory lesions (Baseline inflammatory lesion count) - (Week 6 inflammatory lesion count) __________________________________________________________ x 100% Baseline inflammatory lesion count | 6 weeks | 
| Change from Baseline Non-Inflammatory Lesions at 2 weeks | Numeric data of total reduction (improvement) of non-inflammatory lesions (Baseline non-inflammatory lesion count) - (Week 2 non-inflammatory lesion count) __________________________________________________________ x 100% Baseline non-inflammatory lesion count | 2 weeks | 
| Change from Baseline Non-Inflammatory Lesions at 4 weeks | Numeric data of total reduction (improvement) of non-inflammatory lesions (Baseline non-inflammatory lesion count) - (Week 4 non-inflammatory lesion count) __________________________________________________________ x 100% Baseline non-inflammatory lesion count | 4 weeks | 
| Change from Baseline Non-Inflammatory Lesions at 6 weeks | Numeric data of total reduction (improvement) of non-inflammatory lesions (Baseline non-inflammatory lesion count) - (Week 6 non-inflammatory lesion count) __________________________________________________________ x 100% Baseline non-inflammatory lesion count | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Improvement at 2 weeks | Improvement of clinical manifestation based on subjective complaints. Subjects were asked to grade overall response using rating scale (0-4), with higher score means a better outcome (0) no or minimal improvement mild improvement moderate improvement robust improvement very good improvement | 2 weeks | 
| Subjective Improvement at 4 weeks | Improvement of clinical manifestation based on subjective complaints. Subjects were asked to grade overall response using rating scale (0-4), with higher score means a better outcome (0) no or minimal improvement mild improvement moderate improvement robust improvement very good improvement | 4 weeks | 
| Subjective Improvement at 6 weeks | Improvement of clinical manifestation based on subjective complaints. Subjects were asked to grade overall response using rating scale (0-4), with higher score means a better outcome (0) no or minimal improvement mild improvement moderate improvement robust improvement very good improvement | 6 weeks | 
| Number of Participants with Side Effects at 2 weeks | Mild side effects if it did not need further management and research medication could be continued. Moderate side effects if clinical manifestations were robust, itchy, pain, erythematous, yet did not need further management and temporary. Severe side effects if it interfered daily activity, such as burn and pain sensastion, erythematous skin, edema, skin exfoliation, that needed further management. | 2 weeks | 
| Number of Participants with Side Effects at 4 weeks | Mild side effects if it did not need further management and research medication could be continued. Moderate side effects if clinical manifestations were robust, itchy, pain, erythematous, yet did not need further management and temporary. Severe side effects if it interfered daily activity, such as burn and pain sensastion, erythematous skin, edema, skin exfoliation, that needed further management. | 4 weeks | 
| Number of Participants with Side Effects at 6 weeks | Mild side effects if it did not need further management and research medication could be continued. Moderate side effects if clinical manifestations were robust, itchy, pain, erythematous, yet did not need further management and temporary. Severe side effects if it interfered daily activity, such as burn and pain sensastion, erythematous skin, edema, skin exfoliation, that needed further management. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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comedone extraction, oral doxycycline, moderate acne vulgaris, HIF-1 alpha expression