- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04555018
Correlation Between Dehydroepiandrosterone Sulfate and Sebum Level in Adult Female Acne Vulgaris
September 17, 2020 updated by: Dr.dr.Irma Bernadette, SpKK (K)
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Jakarta Pusat
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Jakarta, Jakarta Pusat, Indonesia, 10430
- Indonesia dr. Cipto Mangunkusumo Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 49 years (Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Female , age 25-29 years, diagnosed with mild to severe acne vulgaris
Description
Inclusion Criteria:
- Female, age 25-29 years
- Diagnosed with mild to severe acne vulgaris
- Agree to participate
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Crossover
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sebum level
Time Frame: One day
|
Using sebumeter to evaluate the sebum level objectively
|
One day
|
Dehydroepiandrosterone sulfate
Time Frame: One day
|
Blood serum was used to evaluate Dehydroepiandrosterone sulfate level.
|
One day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Irma B Sitohang, MD,PhD, Fakultas Kedokteran Universitas Indonesia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2017
Primary Completion (Actual)
September 1, 2017
Study Completion (Actual)
October 1, 2017
Study Registration Dates
First Submitted
September 14, 2020
First Submitted That Met QC Criteria
September 17, 2020
First Posted (Actual)
September 18, 2020
Study Record Updates
Last Update Posted (Actual)
September 18, 2020
Last Update Submitted That Met QC Criteria
September 17, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DheasSebum
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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