Microbiome Comparison Profile of Normal Skin and Acne Vulgaris Patients

NCT05838534 | Unknown

• 1 other identifier: SkinMicrobiomeComparison
• Study Type: observational
• Target: 144
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this study is to compare the profile of the microbiome on normal skin and acne vulgaris patients. A cross sectional study with 144 samples, male or female between 18-40 years old, from January to May 2023.

Conditions

Acne Vulgaris

Keywords

Skin Microbiome; Normal Skin; Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• Comparison of skin microbiome features on normal and acne vulgaris skin

  Using the swab method on facial skin for microbiome sampling, DNA extraction, amplification, and sequencing were carried out on the sample and the Shannon Index will be calculated. Then, the data will be tabulated and analyzed.

  up to 16 weeks

Study Arms (4)

Normal Skin

Mild Acne Vulgaris

Moderate Acne Vulgaris

Severe Acne Vulgaris

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Male or female, 18-40 years old, normal skin, diagnosed with mild to severe acne

You may qualify if:

• Male or female, 18-40 years old
• Normal individuals who have not had acne vulgaris in the last 5 years and have never had moderate or severe acne vulgaris
• Patients with mild, moderate, or severe acne vulgaris who have acne vulgaris lesions that are representative of the grade and equally distributed in all facial regions (forehead, cheeks, and chin)
• Patients agree to participate in the study and sign informed consent

You may not qualify if:

• Pregnancy
• Diagnosed with other inflammatory or infectious diseases on the face
• Diagnosed with psoriasis or have atopic
• Diagnosed with primary or secondary immunodeficiency disease
• Patients with a history of laser therapy or facial dermabrasion within the past month
• Using oral or systemic antibiotics, anti-inflammatory, retinoids or hormone therapy in the last 1 month
• Using topical retinoid therapy, antibiotics, benzoyl peroxide, or other topical products in the last 2 weeks
• Acne conglobata

Sponsors & Collaborators

• Dr.dr.Irma Bernadette, SpKK (K): lead

Study Sites (2)

Clinical Research Supporting Unit- Faculty of Medicine, University of Indonesia

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Dr. Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Related Publications (1)

• Manurung THP, Sitohang IBS, Agustin T. Staphylococcus caprae and Staphylococcus epidermidis define the skin microbiome among different grades of acne vulgaris. Arch Dermatol Res. 2024 Dec 30;317(1):156. doi: 10.1007/s00403-024-03581-1.

  PMID: 39738874 DERIVED

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Irma Bernadette Sitohang, MD

  Faculty of Medicine, University of Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. dr. Irma Bernadette S. Sitohang, SpKK - Head of Cosmetic Dermatology Division, Department of Dermatology and Venereology, Faculty of Medicine, Universitas Indonesia, dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: May 1, 2023
• Study Start: January 17, 2023
• Primary Completion: March 24, 2023
• Study Completion: May 24, 2023
• Last Updated: May 1, 2023

Record last verified: 2023-04

Locations

ID (2)