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

Dr.dr.Irma Bernadette, SpKK (K)46 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Photoaging

Interventions

0.05% TretinoinDRUG

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

Eligibility

Sex: FEMALEMin age: 35 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Indonesia dr. Cipto Mangunkusumo Hospital

Jakarta, Jakarta Pusat, Indonesia

Outcomes

Primary Outcomes

Change of Photoaged Skin Condition

using dermoscopic photoaging scale (DPAS). This DPAS assessment is based on yes or no rules on 11 criteria in four facial regions, namely left malar, right malar, forehead, and chin. The criteria were yellowish discoloration, white line, lentigo, hypo- and hyper-pigmented macules, telangiectasia, yellow papules, actinic keratosis, senile comedones, deep wrinkle, superficial wrinkle, and criss-cross wrinkle. Score range is 0-44 points.

Time frame: Baseline(pre-chemical peeling procedure), immediately after chemical peeling procedure, and 4 weeks after chemical peeling procedure

Change of Subjective Pain Evaluation

using Visual Analog Scale (VAS). Scale range is 0-10, 0 indicates no pain and 10 indicates severe pain

Time frame: Baseline(pre-chemical peeling procedure), immediately after chemical peeling procedure, and 4 weeks after chemical peeling procedure

Change of Erythema Degree

using Clinician Erythema Assessment Scale (CEA). Scale range is 0-4, 0 indicates no erythema and 4 indicates severe erythema

Time frame: Baseline(pre-chemical peeling procedure), immediately after chemical peeling procedure, and 4 weeks after chemical peeling procedure

Change in Skin Thickness

Evaluation with USG of epidermal and dermal layer (in pixels)

Time frame: Baseline(pre-chemical peeling procedure) and 4 weeks after chemical peeling procedure

Central Contacts

Irma BS Sitohang, MD

CONTACT

+62818130761 irma_bernadette@yahoo.com

Data from ClinicalTrials.gov

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