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

Study Overview
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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.

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.

Official Title
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Effectivity of 1 Finger Tip Unit Compared to 2 Finger Tip Units 0.05% Tretinoin Cream Before and After 30% Trichloroacetic Acid Chemical Peeling on Aging Skin

Conditions
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Photoaging

Intervention / Treatment
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* Drug: 0.05% Tretinoin


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1 Fingertip Unit 0.05% Tretinoin<br>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. | Drug: 0.05% Tretinoin<br>* Topical 0.05% tretinoin cream applied daily every night by the subjects according to assigned randomization<br>|
| Experimental: 2 Fingertip Units 0.05% Tretinoin<br>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. | Drug: 0.05% Tretinoin<br>* Topical 0.05% tretinoin cream applied daily every night by the subjects according to assigned randomization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | 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) | Baseline(pre-chemical peeling procedure) and 4 weeks after chemical peeling procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Photoaging, Tretinoin, Trichloroacetic Acid, Chemical Peeling