NCT04555018

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 18, 2020

Completed
Last Updated

September 18, 2020

Status Verified

September 1, 2020

Enrollment Period

3 months

First QC Date

September 14, 2020

Last Update Submit

September 17, 2020

Conditions

Acne VulgarisFemale

Keywords

Acne vulgarisSebum levelDehydroepiandrosterone Sulfate

Outcome Measures

Primary Outcomes (2)

  • Sebum level

    Using sebumeter to evaluate the sebum level objectively

    One day

  • Dehydroepiandrosterone sulfate

    Blood serum was used to evaluate Dehydroepiandrosterone sulfate level.

    One day

Eligibility Criteria

Age25 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Female , age 25-29 years, diagnosed with mild to severe acne vulgaris

You may qualify if:

  • Female, age 25-29 years
  • Diagnosed with mild to severe acne vulgaris
  • Agree to participate

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indonesia dr. Cipto Mangunkusumo Hospital

Jakarta, Jakarta Pusat, 10430, Indonesia

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Study Officials

  • Irma B Sitohang, MD,PhD

    Fakultas Kedokteran Universitas Indonesia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
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

Study Record Dates

First Submitted

September 14, 2020

First Posted

September 18, 2020

Study Start

June 1, 2017

Primary Completion

September 1, 2017

Study Completion

October 1, 2017

Last Updated

September 18, 2020

Record last verified: 2020-09

Locations

ID(1)