Effectivity of 1 Finger Tip Unit Compared to 2 Finger Tip Units 0.05% Tretinoin Cream

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2022-01-31

Brief Summary

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This clinical study will compare the efficacy of using one fingertip unit and two fingertip units of 0.05% before and after 30% trichloroacetic acid chemical peel procedure for facial skin rejuvenation in 35-60 years old female patients with Glogau II-III skin classification.

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Detailed Description

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This study is an experimental study with a randomized controlled trial (RCT) design on patients who met the inclusion criteria. Group A will receive pretreatment in the form of 0.05% tretinoin cream which is used as much as one fingertip unit every night, and group B will receive the same cream which should be used as much as two fingertip units. This cream will be used for two weeks before the patients receive a chemical peeling therapy using 30% trichloroacetic acid. The results of therapy will mainly be assessed based on the Dermoscopic Photoaging Scale (DPAS), as well as visual analog scale (VAS) for subjective symptoms and Clinician Erythema Assessment Scale (CEA) for erythema.

Conditions

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Photoaging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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1 Fingertip Unit 0.05% Tretinoin

Subjects were randomized to receive the instructions to use 1 fingertip unit of 0.05% tretinoin cream for 2 weeks before the first chemical peeling. After that, this therapy is instructed to be used for 4 weeks after the chemical peeling procedure with 30% trichloroacetic acid until the scheduled evaluation.

Group Type ACTIVE_COMPARATOR

0.05% Tretinoin

Intervention Type DRUG

Topical 0.05% tretinoin cream applied daily every night by the subjects according to assigned randomization

2 Fingertip Units 0.05% Tretinoin

Subjects were randomized to receive the instructions to use 2 fingertip units of 0.05% tretinoin cream for 2 weeks before the first chemical peeling. After that, this therapy is instructed to be used for 4 weeks after the chemical peeling procedure with 30% trichloroacetic acid until the scheduled evaluation.

Group Type EXPERIMENTAL

0.05% Tretinoin

Intervention Type DRUG

Topical 0.05% tretinoin cream applied daily every night by the subjects according to assigned randomization

Interventions

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0.05% Tretinoin

Topical 0.05% tretinoin cream applied daily every night by the subjects according to assigned randomization

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Female patients aged 35-60 years old
* Patients with Glogau II-III skin classification
* Patients are willing to participate in the study and sign an informed consent form

Exclusion Criteria

* Patients with hypertrophic scars or keloid on the face
* Patients with open wound or infection on the face
* History of other topical treatment on the face within 1 month of enrollment
* Pregnant or breastfeeding mother
* Patients and/or their families are not willing to participate in the study.

Minimum Eligible Age

35 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Dr.dr.Irma Bernadette, SpKK (K)

Irma Bernadette S. Sitohang, MD, PhD - Head of Cosmetic Dermatology Division, Department of Dermatology and Venereology, Faculty of Medicine, Universitas Indonesia, dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia

Responsibility Role SPONSOR_INVESTIGATOR