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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Photoaging
• Intervention / Treatment: Drug: 0.05% Tretinoin

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 Type: Interventional
• Enrollment (Anticipated): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta Pusat
    • Jakarta, Jakarta Pusat, Indonesia, 10430
      • Indonesia dr. Cipto Mangunkusumo Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: 0.05% Tretinoin; Topical 0.05% tretinoin cream applied daily every night by the subjects according to assigned randomization
Experimental: 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.	Drug: 0.05% Tretinoin; Topical 0.05% tretinoin cream applied daily every night by the subjects according to assigned randomization

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dr.dr.Irma Bernadette, SpKK (K)

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): December 30, 2021
• Study Completion (Anticipated): January 31, 2022

Study Registration Dates

• First Submitted: July 27, 2021
• First Submitted That Met QC Criteria: August 9, 2021
• First Posted (Actual): August 13, 2021

Study Record Updates

• Last Update Posted (Actual): August 13, 2021
• Last Update Submitted That Met QC Criteria: August 9, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Photoaging; Tretinoin; Trichloroacetic Acid; Chemical Peeling
• Additional Relevant MeSH Terms: Antineoplastic Agents; Dermatologic Agents; Keratolytic Agents; Tretinoin
• Other Study ID Numbers: TretandTCAPeeling

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No