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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05186246
Other study ID # EffectivityCombiSpentGrain
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date December 20, 2021
Est. completion date February 28, 2022

Study information

Verified date January 2022
Source Indonesia University
Contact Irma BS Sitohang, MD
Phone +62818130761
Email irma_bernadette@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date February 28, 2022
Est. primary completion date January 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Women aged 18-60 years old with an understanding of all the information given by written consent form - Had undergone priming with tretinoin cream 0,05% for 2 weeks pre fractional CO2 laser treatment 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 of enrollment - Pigmentary disorders or any dermatoses, which may affect the measurement within the study areas - A pregnant or breastfeeding mother - History of hormonal or endocrine diseases or taking medication for hormonal or endocrine diseases - Inability to comply research protocols

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Combination cream
Spent Grain Wax, Argan Oil, Shea Butter and Saccharide Isomerate Cream combination (10 gram), were applied on one side of the face twice daily by participants.
Placebo cream
Cream that is identical looking were given to subjects to be applied on the other side of the face twice daily

Locations

Country Name City State
Indonesia Rumah Sakit Angkatan Darat Gatot Soebroto Jakarta DKI Jakarta

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 Eryhtema Score Based on Clinical Erythema Assessment Scale. Scale range is 0-4, 0 indicates no erythema and 4 indicates severe erythema baseline; 3 days post fractional CO2 laser; and 7 days post fractional CO2 laser
Primary Change of Photoaging Skin Condition 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; 3 days post fractional CO2 laser; and 7 days post fractional CO2 laser
Primary Change of Subjective Pain Evaluation Assessed using Visual Analog Scale (VAS). Scale range is 0-10, 0 indicates no pain and 10 indicates severe pain baseline; 3 days post fractional CO2 laser; and 7 days post fractional CO2 laser
Primary Change of Skin Capacitance Assessed using TEWAmeter to see changes in Skin Capacitance baseline; 3 days post fractional CO2 laser; and 7 days post fractional CO2 laser
Primary Change of Skin Conditions of patients assessed by Janus Facial Analysis System Assessed using Janus Facial Analysis System® Skin will be assessed using Janus with three different wavelength of light which are normal, polarized and UV light. The skin will be analyzed for pores, wrinkles, sebum and skin tone baseline; 3 days post fractional CO2 laser; and 7 days post fractional CO2 laser
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