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NCT06181838 Clinical Trial

Comparison of Quality of Life in Moderate Acne Vulgaris Patients Based on Acne-QoL-INA Using Standard Therapy With and Without Acne Lesions Extraction

Quality of Life Clinical Trial

Official title:
Single-Blinded Randomized Controlled Trial: Comparison of Quality of Life in Moderate Acne Vulgaris Patients Based on Acne-QoL-INA Using Standard Therapy With and Without Acne Lesions Extraction

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT06181838
Other study ID # 23-05-0571
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date August 28, 2023
Est. completion date January 3, 2024

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

Clinical Trial Summary

This study will compare the quality of life between 2 groups, which are group that receive standard moderate acne therapy in addition of lesion extractions, and the second group which only receive standard moderate acne therapy without lesion extractions.

Description:

The group allocation will be randomized. Outcome of the study is the quality of life score based on Acne-QoL-INA questionnaire. The study duration is 8 weeks, consists of baseline visit and 2 follow ups at 4th and 8th weeks.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 40
Est. completion date January 3, 2024
Est. primary completion date November 24, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 59 Years
Eligibility Inclusion Criteria: - Clinically diagnosed as moderate acne vulgaris - Able to read and speak in Indonesia - Indonesian Citizen - Sign the consent form Exclusion Criteria: - Pregnant of breastfeeding women - Acne vulgaris lesion located only outside of face - Experiencing COVID-19 symptoms - Using retinoid acid containing cream or benzoil peroxide in the last 2 weeks - Consume any oral antibiotics in the last 1 month - Injected with intralesional steroid or having acne lesions extracted in the last 2 weeks - Having laser or chemical peeling in the last 1 month

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Lesion extraction
Tretinoin and benzoil peroxide used concurent in both groups as standard therapy
Drug:
• Tretinoin
Tretinoin and benzoil peroxide used concurent in both groups as standard therapy

Locations
Country Name City State
Indonesia Rumah Sakit Umum Pusat Nasional Dr. Cipto Mangunkusumo Jakarta Pusat DKI Jakarta

Sponsors (1)
Lead Sponsor Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Quality of Life Score Measured using Acne-QoL-INA questionnaire Every 4 weeks, measured until 8 weeks
Secondary Acne Grading Lehmann classification of Acne Grading Every 4 weeks, measured until 8 weeks
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