Clinical trial

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

Name

23-05-0571

Description

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.

Trial arms

Trial start

2023-08-28

Estimated PCD

2023-11-24

Trial end

2024-01-03

Status

Active (not recruiting)

Treatment

Lesion extraction

Tretinoin and benzoil peroxide used concurent in both groups as standard therapy

Arms:

Intervention

Other names:

Tretinoin, Benzoil peroxide

Tretinoin

Tretinoin and benzoil peroxide used concurent in both groups as standard therapy

Arms:

Control

Other names:

Benzoil peroxide

Size

Primary endpoint

Quality of Life Score

Every 4 weeks, measured until 8 weeks

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ACTUAL'}}

Updated at

2023-12-29

1 organization

1 product

2 indications

Organization

Product

Indication

Indication