Effectivity and Safety of Combination of Spent Grain Wax, Argan Oil, Shea Butter and Saccharide Isomerate

Last updated: January 6, 2022
Sponsor: Dr.dr.Irma Bernadette, SpKK (K)
Overall Status: Active - Recruiting

Phase

1

Condition

Acne

Rash

Inflammatory Comedones

Treatment

N/A

Clinical Study ID

NCT05186246
EffectivityCombiSpentGrain
  • Ages 18-60
  • Female
  • Accepts Healthy Volunteers

Study Summary

The clinical study will compare the efficacy and safety of Combination of Spent Grain Wax, Argan Oil, Shea Butter and Saccharide Isomerate cream post fractional CO2 laser. Combination of Spent Grain Wax, Argan Oil, and Shea Butter was formulated to reduce skin irritation and allergy symptoms such as dryness, itch and rash. The combination cream applied on one side of the face while placebo will be applied on the other side of the face in 18-60 years old female post fractional CO2 laser.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Women aged 18-60 years old with an understanding of all the information given bywritten consent form
  • Had undergone priming with tretinoin cream 0,05% for 2 weeks pre fractional CO2 lasertreatment

Exclusion

Exclusion Criteria:

  • Personal or family history of skin cancer, especially melanoma
  • Consumption of systemic retinoic acid within 3 month of enrollment
  • Use of any topical skin brightening or whitening preparations within 1 month ofenrollment
  • Pigmentary disorders or any dermatoses, which may affect the measurement within thestudy areas
  • A pregnant or breastfeeding mother
  • History of hormonal or endocrine diseases or taking medication for hormonal orendocrine diseases
  • Inability to comply research protocols

Study Design

Total Participants: 20
Study Start date:
December 20, 2021
Estimated Completion Date:
February 28, 2022

Study Description

This study is an experimental study with a randomized controlled trial (RCT) design on patients who met the inclusion criteria. All participants will receive pretreatment in the form of 0.05% tretinoin cream for two weeks, then all participants will undergo fractional CO2 laser treatment. Post laser treatment, the participants will be given cream A and B, which already randomized to be applied on to the face. All participants will be evaluated in day 3 and day 7 post fractional CO2 laser. 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 and Skin Capacitance measured with TEWAmeter.

Connect with a study center

  • Rumah Sakit Angkatan Darat Gatot Soebroto

    Jakarta, DKI Jakarta 10410
    Indonesia

    Active - Recruiting

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