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

University of Indonesia (UI)

Status and phase

Completed

Phase 1

Conditions

Acne Vulgaris

Treatments

Drug: Doxycycline Capsule

Procedure: Comedone extraction

Study type

Interventional

Funder types

Other

Identifiers

NCT04206631

ComExt

Details and patient eligibility

About

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.

Full 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.

Enrollment

140 patients

Sex

All

Ages

15 to 50 years old

Volunteers

Accepts Healthy Volunteers

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