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

Not Applicable

• Conditions: Photoaging
• Interventions: Drug: 0.05% Tretinoin

• Registration Number: NCT05004909
• Lead Sponsor: Dr.dr.Irma Bernadette, SpKK (K)

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2021-07-27
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-09
• Last Update Submitted: 2021-08-09
• Study First Posted: 2021-08-13
• Last Update Posted: 2021-08-13
• Study Start: 2021-09-01
• Primary Completion: 2021-12-30
• Study Completion: 2022-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 46

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2 Fingertip Units 0.05% Tretinoin	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.
1 Fingertip Unit 0.05% Tretinoin	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.

Primary Outcome Measures

Name	Time	Method
Change of Subjective Pain Evaluation	Baseline(pre-chemical peeling procedure), immediately after chemical peeling procedure, and 4 weeks after chemical peeling procedure	using Visual Analog Scale (VAS). Scale range is 0-10, 0 indicates no pain and 10 indicates severe pain
Change in Skin Thickness	Baseline(pre-chemical peeling procedure) and 4 weeks after chemical peeling procedure	Evaluation with USG of epidermal and dermal layer (in pixels)
Change of Photoaged Skin Condition	Baseline(pre-chemical peeling procedure), immediately after chemical peeling procedure, and 4 weeks after chemical peeling procedure	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.
Change of Erythema Degree	Baseline(pre-chemical peeling procedure), immediately after chemical peeling procedure, and 4 weeks after chemical peeling procedure	using Clinician Erythema Assessment Scale (CEA). Scale range is 0-4, 0 indicates no erythema and 4 indicates severe erythema

Trial Locations

Locations (1)

Indonesia dr. Cipto Mangunkusumo Hospital; 🇮🇩 Jakarta, Jakarta Pusat, Indonesia