Comparison of Quality of Life in Moderate Acne Vulgaris Patients Based on Acne-QoL-INA Using Standard Therapy With and Without Acne Lesions Extraction
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
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 24, 2023
CompletedFirst Submitted
Initial submission to the registry
December 13, 2023
CompletedFirst Posted
Study publicly available on registry
December 26, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 3, 2024
CompletedDecember 29, 2023
December 1, 2023
3 months
December 13, 2023
December 24, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Quality of Life Score
Measured using Acne-QoL-INA questionnaire
Every 4 weeks, measured until 8 weeks
Secondary Outcomes (1)
Acne Grading
Every 4 weeks, measured until 8 weeks
Study Arms (2)
Intervention
ACTIVE COMPARATORStandard therapy and lesion extraction
Control
PLACEBO COMPARATORStandard therapy without lesion extraction
Interventions
Tretinoin and benzoil peroxide used concurent in both groups as standard therapy
Tretinoin and benzoil peroxide used concurent in both groups as standard therapy
Eligibility Criteria
You may qualify if:
- Clinically diagnosed as moderate acne vulgaris
- Able to read and speak in Indonesia
- Indonesian Citizen
- Sign the consent form
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rumah Sakit Umum Pusat Nasional Dr. Cipto Mangunkusumo
Jakarta Pusat, DKI Jakarta, 10430, Indonesia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor
Study Record Dates
First Submitted
December 13, 2023
First Posted
December 26, 2023
Study Start
August 28, 2023
Primary Completion
November 24, 2023
Study Completion
January 3, 2024
Last Updated
December 29, 2023
Record last verified: 2023-12