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

D

Dr.dr.Irma Bernadette, SpKK (K)

Status

Unknown

Conditions

Photoaging

Treatments

Drug: 0.05% Tretinoin

Study type

Interventional

Funder types

Other

Identifiers

NCT05004909
TretandTCAPeeling

Details and patient eligibility

About

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.

Full 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.

Enrollment

46 estimated patients

Sex

Female

Ages

35 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

46 participants in 2 patient groups

1 Fingertip Unit 0.05% Tretinoin
Active Comparator group
Description:
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.
Treatment:
Drug: 0.05% Tretinoin
2 Fingertip Units 0.05% Tretinoin
Experimental group
Description:
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.
Treatment:
Drug: 0.05% Tretinoin

Trial contacts and locations

1

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Central trial contact

Irma BS Sitohang, MD

Data sourced from clinicaltrials.gov

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