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

Acne Vulgaris Clinical Trial

Official title:

Effectivity and Safety of Combination of Spent Grain Wax, Argan Oil, Shea Butter and Saccharide Isomerate Post Fractional CO2 Laser

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05186246
• Other study ID #: EffectivityCombiSpentGrain
• Status: Recruiting
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Acne Vulgaris

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