Clinical trial NCT04206631: Comedone Extraction and Oral Doxycycline In The First Line Treatment of Moderate Acne Vulgaris
Official title: Effectiveness of Comedone Extraction and Oral Doxycycline In The First Line Treatment of Moderate Acne Vulgaris: Study on HIF-1 Alpha Expression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acne Vulgaris
Keywords: comedone extraction
oral doxycycline
moderate acne vulgaris
HIF-1 alpha expression
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2019-12-20
Enrollment: 140
Sex: ALL
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility 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

Primary outcomes:
measure: Change from Baseline Inflammatory Lesions at 2 weeks
timeFrame: 2 weeks
measure: Change from Baseline Inflammatory Lesions at 4 weeks
timeFrame: 4 weeks
measure: Change from Baseline Inflammatory Lesions at 6 weeks
timeFrame: 6 weeks
measure: Change from Baseline Non-Inflammatory Lesions at 2 weeks
timeFrame: 2 weeks
measure: Change from Baseline Non-Inflammatory Lesions at 4 weeks
timeFrame: 4 weeks
measure: Change from Baseline Non-Inflammatory Lesions at 6 weeks
timeFrame: 6 weeks
Secondary outcomes:
measure: Subjective Improvement at 2 weeks
timeFrame: 2 weeks
measure: Subjective Improvement at 4 weeks
timeFrame: 4 weeks
measure: Subjective Improvement at 6 weeks
timeFrame: 6 weeks
measure: Number of Participants with Side Effects at 2 weeks
timeFrame: 2 weeks
measure: Number of Participants with Side Effects at 4 weeks
timeFrame: 4 weeks
measure: Number of Participants with Side Effects at 6 weeks
timeFrame: 6 weeks
Other outcomes:
measure: Expression of Antibody HIF-1 Alpha with Immunohistochemistry Examination
timeFrame: Baseline
measure: Expression of Antibody HIF-1 Alpha with ELISA Examination
timeFrame: Baseline
Locations:
Study officials:
affiliation: Fakultas Kedokteran Universitas Indonesia
name: Irma B Sitohang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sitohang IBS, Soebaryo RW, Kanoko M. Acne Lesion Extraction versus Oral Doxycycline for Moderate Acne Vulgaris: A Randomized Clinical Trial. J Clin Aesthet Dermatol. 2021 Jun;14(6):E61-E65. Epub 2021 Jun 1.