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

December 24, 2023 updated by: Christa Desire Gracia, Indonesia University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
        • Rumah Sakit Umum Pusat Nasional Dr. Cipto Mangunkusumo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention
Standard therapy and lesion extraction
Procedure: Lesion extraction
Tretinoin and benzoil peroxide used concurent in both groups as standard therapy
Other Names:
  • Tretinoin
  • Benzoil peroxide
Placebo Comparator: Control
Standard therapy without lesion extraction
Drug: Tretinoin
Tretinoin and benzoil peroxide used concurent in both groups as standard therapy
Other Names:
  • Benzoil peroxide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life Score
Time Frame: Every 4 weeks, measured until 8 weeks
Measured using Acne-QoL-INA questionnaire
Every 4 weeks, measured until 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acne Grading
Time Frame: Every 4 weeks, measured until 8 weeks
Lehmann classification of Acne Grading
Every 4 weeks, measured until 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2023

Primary Completion (Actual)

November 24, 2023

Study Completion (Estimated)

January 3, 2024

Study Registration Dates

First Submitted

December 13, 2023

First Submitted That Met QC Criteria

December 13, 2023

First Posted (Actual)

December 26, 2023

Study Record Updates

Last Update Posted (Actual)

December 29, 2023

Last Update Submitted That Met QC Criteria

December 24, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-05-0571

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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