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

Photoaging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05004909
• Other study ID #: TretandTCAPeeling
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: August 2021
• Source: Indonesia University
• Contact: Irma BS Sitohang, MD
• Phone: +62818130761
• Email: irma_bernadette[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 46
• Est. completion date: January 31, 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Photoaging

Intervention

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

Locations

Country	Name	City	State
Indonesia	Indonesia dr. Cipto Mangunkusumo Hospital	Jakarta	Jakarta Pusat

Sponsors (1)

Lead Sponsor	Collaborator
Dr.dr.Irma Bernadette, SpKK (K)

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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