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

NCT04206631 | Completed Phase 1

• 1 other identifier: ComExt
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acne Vulgaris

Keywords

comedone extraction; oral doxycycline; moderate acne vulgaris; HIF-1 alpha expression

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (6)

• Subjective Improvement at 2 weeks

  2 weeks

• Subjective Improvement at 4 weeks

  4 weeks

• Subjective Improvement at 6 weeks

  6 weeks

• Number of Participants with Side Effects at 2 weeks

  2 weeks

• Number of Participants with Side Effects at 4 weeks

  4 weeks

Other Outcomes (2)

• Expression of Antibody HIF-1 Alpha with Immunohistochemistry Examination

  Baseline

• Expression of Antibody HIF-1 Alpha with ELISA Examination

  Baseline

Study Arms (2)

Doxycycline Group

PLACEBO COMPARATOR

Subjects were randomized to receive Doxycycline capsules. The capsules were taken once daily for 6 weeks and evaluated every 2 weeks.

Drug: Doxycycline Capsule

Comedone Extraction Group

ACTIVE COMPARATOR

Subjects were randomized to receive comedone extraction. Comedone extraction were done three times, and evaluated every 2 weeks.

Procedure: Comedone extraction

Interventions

Doxycycline Capsule DRUG

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.

Doxycycline Group

Comedone extraction PROCEDURE

Comedone extraction, tretinoin cream 0.05% on face every night, benzoyl peroxide gel 2.5% on face in the morning and afternoon.

Comedone Extraction Group

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Related Publications (1)

• 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.

  PMID: 34804358 DERIVED

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Irma B Sitohang, MD, PhD

  Fakultas Kedokteran Universitas Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Irma Bernadette S. Sitohang, MD, PhD - Head of Division of Cosmetic Dermatology, Department of Dermatology and Venereology, Faculty of Medicine, Universitas Indonesia, dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: December 20, 2019
• Study Start: April 1, 2015
• Primary Completion: September 30, 2015
• Study Completion: October 14, 2015
• Last Updated: December 20, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share