Effectivity of 1 Finger Tip Unit Compared to 2 Finger Tip Units 0.05% Tretinoin Cream
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Change of Photoaged Skin Condition [Baseline(pre-chemical peeling procedure), immediately after chemical peeling procedure, and 4 weeks after chemical peeling procedure]
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.
- Change of Subjective Pain Evaluation [Baseline(pre-chemical peeling procedure), immediately after chemical peeling procedure, and 4 weeks after chemical peeling procedure]
using Visual Analog Scale (VAS). Scale range is 0-10, 0 indicates no pain and 10 indicates severe pain
- Change of Erythema Degree [Baseline(pre-chemical peeling procedure), immediately after chemical peeling procedure, and 4 weeks after chemical peeling procedure]
using Clinician Erythema Assessment Scale (CEA). Scale range is 0-4, 0 indicates no erythema and 4 indicates severe erythema
- Change in Skin Thickness [Baseline(pre-chemical peeling procedure) and 4 weeks after chemical peeling procedure]
Evaluation with USG of epidermal and dermal layer (in pixels)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Female patients aged 35-60 years old
-
Patients with Glogau II-III skin classification
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Patients are willing to participate in the study and sign an informed consent form
Exclusion Criteria:
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Patients with hypertrophic scars or keloid on the face
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Patients with open wound or infection on the face
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History of other topical treatment on the face within 1 month of enrollment
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Pregnant or breastfeeding mother
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Patients and/or their families are not willing to participate in the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Indonesia dr. Cipto Mangunkusumo Hospital | Jakarta | Jakarta Pusat | Indonesia | 10430 |
Sponsors and Collaborators
- Dr.dr.Irma Bernadette, SpKK (K)
Investigators
- Principal Investigator: Irma BS Sitohang, MD, Fakultas Kedokteran Universitas Indonesia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TretandTCAPeeling