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

NCT05004909 | Unknown

• 1 other identifier: TretandTCAPeeling
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Photoaging

Keywords

Photoaging; Tretinoin; Trichloroacetic Acid; Chemical Peeling

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

1 Fingertip Unit 0.05% Tretinoin

ACTIVE COMPARATOR

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

2 Fingertip Units 0.05% Tretinoin

EXPERIMENTAL

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

Interventions

0.05% Tretinoin DRUG

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

1 Fingertip Unit 0.05% Tretinoin; 2 Fingertip Units 0.05% Tretinoin

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Indonesia dr. Cipto Mangunkusumo Hospital

Jakarta, Jakarta Pusat, 10430, Indonesia

Location

MeSH Terms

Interventions

Tretinoin

Intervention Hierarchy (Ancestors)

Vitamin A; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Study Officials

• Irma BS Sitohang, MD

  Fakultas Kedokteran Universitas Indonesia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Irma BS Sitohang, MD

CONTACT

+62818130761; irma_bernadette@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: 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

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: August 13, 2021
• Study Start: September 1, 2021
• Primary Completion: December 30, 2021
• Study Completion: January 31, 2022
• Last Updated: August 13, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)