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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04206631
Recruitment Status : Completed
First Posted : December 20, 2019
Last Update Posted : December 20, 2019
Sponsor:
Information provided by (Responsible Party):
Dr.dr.Irma Bernadette, SpKK (K), Indonesia University

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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Doxycycline Capsule Procedure: Comedone extraction Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Comedone Extraction and Oral Doxycycline In The First Line Treatment of Moderate Acne Vulgaris: Study on HIF-1 Alpha Expression
Actual Study Start Date : April 1, 2015
Actual Primary Completion Date : September 30, 2015
Actual Study Completion Date : October 14, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Placebo Comparator: Doxycycline Group
Subjects were randomized to receive Doxycycline capsules. The capsules were taken once daily for 6 weeks and evaluated every 2 weeks.
Drug: Doxycycline Capsule
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.

Active Comparator: Comedone Extraction Group
Subjects were randomized to receive comedone extraction. Comedone extraction were done three times, and evaluated every 2 weeks.
Procedure: Comedone extraction
Comedone extraction, tretinoin cream 0.05% on face every night, benzoyl peroxide gel 2.5% on face in the morning and afternoon.




Primary Outcome Measures :
  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 Outcome Measures :
  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

    1. mild improvement
    2. moderate improvement
    3. robust improvement
    4. 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

    1. mild improvement
    2. moderate improvement
    3. robust improvement
    4. 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

    1. mild improvement
    2. moderate improvement
    3. robust improvement
    4. 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 Outcome Measures:
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   15 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04206631


Sponsors and Collaborators
Indonesia University
Investigators
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Principal Investigator: Irma B Sitohang, MD, PhD Fakultas Kedokteran Universitas Indonesia
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Responsible Party: Dr.dr.Irma Bernadette, SpKK (K), 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, Indonesia University
ClinicalTrials.gov Identifier: NCT04206631    
Other Study ID Numbers: ComExt
First Posted: December 20, 2019    Key Record Dates
Last Update Posted: December 20, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr.dr.Irma Bernadette, SpKK (K), Indonesia University:
comedone extraction
oral doxycycline
moderate acne vulgaris
HIF-1 alpha expression
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents