Clinical Trials Logo
  1. Home
  2. Acne Vulgaris
  3. NCT05838534
  4. Details
NCT05838534 Clinical Trial

Microbiome Comparison Profile of Normal Skin and Acne Vulgaris Patients

Acne Vulgaris Clinical Trial

Official title:
Microbiome Comparison Profile of Normal Skin and Acne Vulgaris Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05838534
Other study ID # SkinMicrobiomeComparison
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 17, 2023
Est. completion date May 24, 2023

Study information
Verified date April 2023
Source Indonesia University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

Recently, research on the role of the microbiome in the process of acne vulgaris has continued to grow. Seeing the important role of the microbiome in maintaining the balance of skin health, this study aims to compare the profile of the microbiome on normal skin and on acne vulgaris patients, in order to gain a deeper understanding the role of the microbiome in acne vulgaris and also to compare skin microbiome features in various degrees of acne vulgaris severity. This research is an observational study with a cross sectional design. Subject selected by consecutive sampling, with total 144 samples consists of males and females age 18-40. There will be two visits in this research. The first visit, for screening patients with requests for informed consent, giving facial soap, screening for inclusion and exclusion criteria, screening for facial skin complaints and facial care habits, collecting data on patient demographics and medical history, physical examination, sebumeter examination to measure sebum levels on facial skin, and taking clinical photos for documentation. The second visit is collecting microbiome data which will be taking in 1 to 2 weeks after the first visit. Using swab method to take microbiome samples, after that, there will be 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 according to the hypothesis.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 144
Est. completion date May 24, 2023
Est. primary completion date March 24, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Indonesia Clinical Research Supporting Unit- Faculty of Medicine, University of Indonesia Jakarta Pusat DKI Jakarta
Indonesia Dr. Cipto Mangunkusumo Hospital Jakarta Pusat DKI Jakarta

Sponsors (1)
Lead Sponsor Collaborator
Dr.dr.Irma Bernadette, SpKK (K)

Country where clinical trial is conducted

Indonesia, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT04321070 - Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris Phase 1
Recruiting NCT05755256 - The Impact of Probiotics on Skin Hydration in Youth With Mild Acne Phase 2
Completed NCT05131373 - Safety, Tolerability, and Immunogenicity of ORI-A-ce001 for the Treatment of Acne Vulgaris Phase 1
Completed NCT01445301 - Study STF115287, a Clinical Confirmation Study of GSK2585823 in the Treatment of Acne Vulgaris in Japanese Subjects Phase 3
Completed NCT03303170 - Non-Significant Risk Study of Sebacia Microparticles in the Treatment of Facial Acne Vulgaris N/A
Completed NCT04698239 - Clinical Evaluation of the Safety and Benefits of the Milesman 445 nm Blue Laser on Inflammatory Acne Lesions. N/A
Completed NCT02886715 - A Study Comparing Tazarotene Cream 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both to a Placebo Control in the Treatment of Acne Vulgaris Phase 3
Terminated NCT02924428 - Venus Versa Diamondpolar Applicator Treatment Followed by AC Dual Applicator Treatment for Facial Acne Vulgaris N/A
Not yet recruiting NCT02535871 - A Study Comparing the Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris Phase 3
Not yet recruiting NCT02525822 - Study to Compare the Safety and Efficacy of IDP-123 Lotion to Tazorac Cream in the Treatment of Acne Vulgaris Phase 2
Not yet recruiting NCT02491060 - A Study Comparing the Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris Phase 3
Completed NCT02709902 - Study Comparing Adapalene/BP Gel to EPIDUO® FORTE and Both to a Placebo Control in Treatment of Acne Vulgaris Phase 1
Completed NCT02250430 - A Phase 1 Study Assessing Local Cutaneous Effects of SB204 Phase 1
Completed NCT02913001 - The Effect of a Low Glycemic Load Diet on Hormonal Markers Associated With Acne N/A
Completed NCT01769664 - A Study Comparing Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel to Duac® Topical Gel in the Treatment of Acne Vulgaris Phase 1
Completed NCT01694810 - Cutaneous Tolerability and Safety of NVN1000 Topical Gel in Healthy Volunteers Phase 1
Completed NCT01727440 - Identifying the Genetic Predictors of Severe Acne Vulgaris and the Outcome of Oral Isotretinoin Treatment N/A
Completed NCT01194375 - A Dose-Ranging Study Evaluating the Safety and Efficacy of IDP-107 in Patients With Acne Vulgaris Phase 2
Completed NCT01706250 - U0289-401: Eight Week, Split-face, Study to Determine and Compare the Efficacy and Tolerability of MAXCLARITY™ II to PROACTIV™ Phase 4
Completed NCT02524665 - 8 Week Study to Evaluate and Compare the Efficacy and Tolerability of MAXCLARITY II and MURAD To Treat Acne Phase 4