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

Not Applicable

Active, not recruiting

• Conditions: Acne Vulgaris; Quality of Life
• Interventions: Procedure: Lesion extraction; Drug: Tretinoin

• Registration Number: NCT06181838
• Lead Sponsor: Indonesia University

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2023-08-28
• Primary Completion: 2023-11-24
• Status Verified: 2023-12
• Study First Submitted: 2023-12-13
• Study First Submitted QC: 2023-12-13
• Last Update Submitted: 2023-12-24
• Study First Posted: 2023-12-26
• Last Update Posted: 2023-12-29
• Study Completion: 2024-01-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Clinically diagnosed as moderate acne vulgaris
• Able to read and speak in Indonesia
• Indonesian Citizen
• Sign the consent form

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Lesion extraction	Standard therapy and lesion extraction
Control	Tretinoin	Standard therapy without lesion extraction

Primary Outcome Measures

Name	Time	Method
Quality of Life Score	Every 4 weeks, measured until 8 weeks	Measured using Acne-QoL-INA questionnaire

Secondary Outcome Measures

Name	Time	Method
Acne Grading	Every 4 weeks, measured until 8 weeks	Lehmann classification of Acne Grading

Trial Locations

Locations (1)

Rumah Sakit Umum Pusat Nasional Dr. Cipto Mangunkusumo; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia