NCT05267119

Brief Summary

An observational study was performed on 48 women wearing hijab and 48 women not wearing hijab to compare the scalp microbiome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2019

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

October 1, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2020

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 4, 2022

Completed
Last Updated

March 4, 2022

Status Verified

February 1, 2022

Enrollment Period

1.1 years

First QC Date

February 15, 2022

Last Update Submit

February 23, 2022

Conditions

Keywords

scalpmicrobiomehijab

Outcome Measures

Primary Outcomes (1)

  • Alpha diversity and beta diversity of scalp microbiome

    The alpha and beta diversity of scalp microbiome which is generated by bioinformatics analysis from the sample processed with Next-Generation Sequencing

    Up to 2 years

Study Arms (2)

Hijab

Women wearing hijab whose scalp sample was taken for microbiome analysis

Procedure: Swab

No hijab

Women not wearing hijab whose scalp sample was taken for microbiome analysis

Procedure: Swab

Interventions

SwabPROCEDURE

The scalp was swabbed with five strokes which were performed each in a vertical, horizontal, left diagonal, and right diagonal direction. The swab was moved back and forth for 10 times

HijabNo hijab

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy women aged 18 years old or older who had not undergone menopause

You may qualify if:

  • Healthy women
  • Aged 18 years old or older who had not undergone menopause
  • Consenting to the study

You may not qualify if:

  • Scalp and hair diseases (e.g. alopecia, trichotillomania, scalp infection, malignancy)
  • Systemic diseases (diabetes mellitus, liver diseases, renal diseases, autoimmune diseases)
  • Use of topical and oral antifungal agents
  • Use of cytostatic agents
  • Use of topical and oral antibiotics
  • Use of topical and oral vitamin D
  • Use of chemical products on hair (e.g. bleaching, permanent blow, hair coloring, hair straightener)
  • Pregnancy
  • Lactating
  • Hypersensitivity towards basic ingredients of shampoo (e.g. synthetic detergent, conditioner, thickening agent).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Universitas Indonesia

Jakarta, 10430, Indonesia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Skin

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Research and Development Division, Department of Dermatology and Venereology

Study Record Dates

First Submitted

February 15, 2022

First Posted

March 4, 2022

Study Start

October 1, 2019

Primary Completion

November 9, 2020

Study Completion

November 9, 2020

Last Updated

March 4, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations