Clinical trial NCT05004909: Effectivity of 1 Finger Tip Unit Compared to 2 Finger Tip Units 0.05% Tretinoin Cream
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Photoaging
Keywords: Photoaging
Tretinoin
Trichloroacetic Acid
Chemical Peeling
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2021-08-13
Enrollment: 46
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of Photoaged Skin Condition
timeFrame: Baseline(pre-chemical peeling procedure), immediately after chemical peeling procedure, and 4 weeks after chemical peeling procedure
measure: Change of Subjective Pain Evaluation
timeFrame: Baseline(pre-chemical peeling procedure), immediately after chemical peeling procedure, and 4 weeks after chemical peeling procedure
measure: Change of Erythema Degree
timeFrame: Baseline(pre-chemical peeling procedure), immediately after chemical peeling procedure, and 4 weeks after chemical peeling procedure
measure: Change in Skin Thickness
timeFrame: Baseline(pre-chemical peeling procedure) and 4 weeks after chemical peeling procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Indonesia dr. Cipto Mangunkusumo Hospital
state: Jakarta Pusat
Study officials:
affiliation: Fakultas Kedokteran Universitas Indonesia
name: Irma BS Sitohang, MD
role: PRINCIPAL_INVESTIGATOR
References: