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
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Acne Vulgaris
• Quality of Life

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