Skip to main content
OpenTrials
Completed

NCT Number: NCT04206631

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

15 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change from Baseline Inflammatory Lesions at 2 weeks

    Time frame: 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. Change from Baseline Inflammatory Lesions at 4 weeks

    Time frame: 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

  3. Change from Baseline Inflammatory Lesions at 6 weeks

    Time frame: 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

  4. Change from Baseline Non-Inflammatory Lesions at 2 weeks

    Time frame: 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

  5. Change from Baseline Non-Inflammatory Lesions at 4 weeks

    Time frame: 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

  6. Change from Baseline Non-Inflammatory Lesions at 6 weeks

    Time frame: 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

Secondary outcomes

  1. Subjective Improvement at 2 weeks

    Time frame: 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. Subjective Improvement at 4 weeks

    Time frame: 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

  3. Subjective Improvement at 6 weeks

    Time frame: 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

  4. Number of Participants with Side Effects at 2 weeks

    Time frame: 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.

  5. Number of Participants with Side Effects at 4 weeks

    Time frame: 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.

  6. Number of Participants with Side Effects at 6 weeks

    Time frame: 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.

Other outcomes

  1. Expression of Antibody HIF-1 Alpha with Immunohistochemistry Examination

    Time frame: Baseline

    Analysis of HIF-1 Alpha expression on keratinocyte cell of pilosebaceous ducts (samples from skin lesion biopsy) was examined with immunohistochemistry using antibody HIF-1 alpha which was visualized with microscope and photographed to achieve qualitative data.

  2. Expression of Antibody HIF-1 Alpha with ELISA Examination

    Time frame: Baseline

    The measurement of HIF-1 Alpha protein concentration in the sebaceous follicle ducts was conducted through ELISA examination with Cusabio Human Hypoxia-inducible factor

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Dec 20, 2019
Registry last updated
Dec 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.