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

NCT ID: NCT06181838

Last Updated: 2023-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-28

Study Completion Date

2024-01-03

Brief Summary

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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

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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.

Conditions

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Acne Vulgaris Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention

Standard therapy and lesion extraction

Group Type ACTIVE_COMPARATOR

Lesion extraction

Intervention Type PROCEDURE

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

Control

Standard therapy without lesion extraction

Group Type PLACEBO_COMPARATOR

Tretinoin

Intervention Type DRUG

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

Interventions

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Lesion extraction

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

Intervention Type PROCEDURE

Tretinoin

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

Intervention Type DRUG

Other Intervention Names

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Tretinoin Benzoil peroxide Benzoil peroxide

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Christa Desire Gracia

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Rumah Sakit Umum Pusat Nasional Dr. Cipto Mangunkusumo

Jakarta Pusat, DKI Jakarta, Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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23-05-0571

Identifier Type: -

Identifier Source: org_study_id