Acne VulgarisNCT04555018
Correlation Between Dehydroepiandrosterone Sulfate and Sebum Level in Adult Female Acne Vulgaris
An observational study of Acne Vulgaris and Female, run by Dr.dr.Irma Bernadette, SpKK (K) at 1 site in Indonesia.
Trial summary
The aim of this study is to determine the correlation between Dehydroepiandrosterone sulfate (DHEAS) and sebum level in adult female acne. A cross sectional study was conducted with 50 samples, in June to October 2017. Read more about this study
- Who is it for?
- Ages 25 to 49 years, women only
- Conditions the study is for
- Acne Vulgaris, Female
- How many people
- 50 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jun 2017to 1 Oct 2017
- Phase
- Observational
- 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 25 to 49 years
- Women only
- Adult
Study population: Female , age 25-29 years, diagnosed with mild to severe acne vulgaris
Who may be able to join
- Female, age 25-29 years
- Diagnosed with mild to severe acne vulgaris
- Agree to participate
Who cannot join
- History of taking antiandrogen drugs
- History of taking oral and topical antibiotics, using topical retinoid and BPO in the last 4 weeks
- History of taking oral isotretinoin in the last 6 months
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Indonesia dr. Cipto Mangunkusumo Hospital
Jakarta, Jakarta Pusat, 10430
About this study
The aim of this study is to determine the correlation between Dehydroepiandrosterone sulfate (DHEAS) and sebum level in adult female acne. A cross sectional study was conducted with 50 samples, in June to October 2017.
Read the detailed description
Epidemiological studies have shown that number of adult female acne vulgaris (AV) increases. Hormone, sebum production, Propionibacterium acne and inflammatory process are factors involved in AV development. The aim of this study is to determine the correlation between Dehydroepiandrosterone sulfate (DHEAS) and sebum level in adult female acne. This research used cross sectional study with 50 samples, aged 25-49 years by consecutive sampling. The degree of acne vulgaris was evaluated using Lehman criteria , and then the sebum level and DHEAS were measured objectively using sebumeter and serum, respectively.
- Conditions
- Acne Vulgaris, Female
- Keywords
- Acne vulgaris, Sebum level, Dehydroepiandrosterone Sulfate
- Medical subject headings
- Acne Vulgaris
What is being measured
The primary outcome is the main question the study is designed to answer.
Sebum level
Using sebumeter to evaluate the sebum level objectively
Measured: One day
Dehydroepiandrosterone sulfate
Blood serum was used to evaluate Dehydroepiandrosterone sulfate level.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start1 Jun 2017
- Primary completion1 Sep 2017
- Study completion1 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr.dr.Irma Bernadette, SpKK (K)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-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
- NCT04555018
- Sponsor's protocol ID
- DheasSebum
- Status last verified
- Sep 2020
- First submitted
- 14 Sep 2020
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Dehydroepiandrosterone Sulfate and Sebum Level in Adult Female Acne Vulgaris
- ClinicalTrials.gov ID
- NCT04555018
- Acronym / sponsor ID
- DheasSebum
- Conditions
- Acne Vulgaris, Female
- Keywords
- Acne vulgaris, Sebum level, Dehydroepiandrosterone Sulfate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Dr.dr.Irma Bernadette, SpKK (K)University, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 18 Sep 2020 (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 aim of this study is to determine the correlation between Dehydroepiandrosterone sulfate (DHEAS) and sebum level in adult female acne. A cross sectional study was conducted with 50 samples, in June to October 2017.
Detailed description
Epidemiological studies have shown that number of adult female acne vulgaris (AV) increases. Hormone, sebum production, Propionibacterium acne and inflammatory process are factors involved in AV development. The aim of this study is to determine the correlation between Dehydroepiandrosterone sulfate (DHEAS) and sebum level in adult female acne. This research used cross sectional study with 50 samples, aged 25-49 years by consecutive sampling. The degree of acne vulgaris was evaluated using Lehman criteria , and then the sebum level and DHEAS were measured objectively using sebumeter and serum, respectively.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 25 to 49 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Female , age 25-29 years, diagnosed with mild to severe acne vulgaris
Key inclusion criteria (3 listed)
- Female, age 25-29 years
- Diagnosed with mild to severe acne vulgaris
- Agree to participate
Key exclusion criteria (4 listed)
- History of taking antiandrogen drugs
- History of taking oral and topical antibiotics, using topical retinoid and BPO in the last 4 weeks
- History of taking oral isotretinoin in the last 6 months
- Pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sebum level
Time frame: One day
Using sebumeter to evaluate the sebum level objectively
Dehydroepiandrosterone sulfate
Time frame: One day
Blood serum was used to evaluate Dehydroepiandrosterone sulfate level.
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 18 Sep 2020.
Related trials for Acne Vulgaris
Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acne Vulgaris and Female, run by Dr.dr.Irma Bernadette, SpKK (K) at 1 site in 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 3 inclusion and 4 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 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Sebum level (time frame: One day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Sep 2020.