Acne VulgarisPhase 1NCT04206631
Comedone Extraction and Oral Doxycycline In The First Line Treatment of Moderate Acne Vulgaris
A Phase 1 study testing Doxycycline Capsule and Comedone extraction in people with Acne Vulgaris, run by Universitas Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Doxycycline Capsule and Comedone extraction
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2015to 14 Oct 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Effectiveness of Comedone Extraction and Oral Doxycycline In The First Line Treatment of Moderate Acne Vulgaris: Study on HIF-1 Alpha Expression
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.
Read the 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.
- Conditions
- Acne Vulgaris
- Being tested
- Doxycycline Capsule, Comedone extraction
- Keywords
- comedone extraction, oral doxycycline, moderate acne vulgaris, HIF-1 alpha expression
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doxycycline CapsuleDrug
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 extractionProcedure or surgery
Comedone extraction, tretinoin cream 0.05% on face every night, benzoyl peroxide gel 2.5% on face in the morning and afternoon.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Comedone extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 weeks
Secondary outcomes (6)
Subjective Improvement at 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
Measured: 2 weeks
Subjective Improvement at 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
Measured: 4 weeks
Subjective Improvement at 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
Measured: 6 weeks
Number of Participants with Side Effects at 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.
Measured: 2 weeks
Number of Participants with Side Effects at 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.
Measured: 4 weeks
Number of Participants with Side Effects at 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start1 Apr 2015
- Primary completion30 Sep 2015
- Study completion14 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.dr.Irma Bernadette, SpKK (K), Universitas Indonesia
- Investigators
- Irma B Sitohang, MD, PhD, Principal investigator, Fakultas Kedokteran Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04206631
- Sponsor's protocol ID
- ComExt
- Status last verified
- Dec 2019
- First submitted
- 17 Dec 2019
- Last updated
- 20 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34804358
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Comedone Extraction and Oral Doxycycline In The First Line Treatment of Moderate Acne Vulgaris: Study on HIF-1 Alpha Expression
- ClinicalTrials.gov ID
- NCT04206631
- Acronym / sponsor ID
- ComExt
- Conditions
- Acne Vulgaris
- Keywords
- comedone extraction, oral doxycycline, moderate acne vulgaris, HIF-1 alpha expression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 30 Sep 2015 (actual)
- Study completion
- 14 Oct 2015 (actual)
- First posted
- 20 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doxycycline Group | Placebo comparator | Drug: Doxycycline CapsuleSubjects were randomized to receive Doxycycline capsules. The capsules were taken once daily for 6 weeks and evaluated every 2 weeks. |
| Comedone Extraction Group | Active comparator | Procedure: Comedone extractionSubjects were randomized to receive comedone extraction. Comedone extraction were done three times, and evaluated every 2 weeks. |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doxycycline CapsuleDoxycycline capsule 100 mg/day, tretinoin cream 0.05% on face every night, benzoyl peroxide gel 2.5% on face in the morning and afternoon. | Drug | Doxycycline Group |
| Comedone extractionComedone extraction, tretinoin cream 0.05% on face every night, benzoyl peroxide gel 2.5% on face in the morning and afternoon. | Procedure or surgery | Comedone Extraction Group |
Primary outcome
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
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
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
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
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
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
6 secondary outcomes
Subjective Improvement at 2 weeks
Time frame: 2 weeks
Subjective Improvement at 4 weeks
Time frame: 4 weeks
Subjective Improvement at 6 weeks
Time frame: 6 weeks
Number of Participants with Side Effects at 2 weeks
Time frame: 2 weeks
Number of Participants with Side Effects at 4 weeks
Time frame: 4 weeks
Number of Participants with Side Effects at 6 weeks
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2019.
- Derived from this study: PubMed 34804358Sitohang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irma B Sitohang, MD, PhD principal investigator
Fakultas Kedokteran Universitas Indonesia
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Doxycycline Capsule and Comedone extraction in people with Acne Vulgaris, run by Universitas Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Inflammatory Lesions at 2 weeks (time frame: 2 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04206631, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2019.