EFFECTIVENESS AND SAFETY OF CREAM CONTAINING SPENT GRAIN WAX EXTRACT, ARGAN OIL, AND SHEA BUTTER POST-TRICHOLOROACETIC ACID 15% PEEL: RANDOMIZED, CONTROLLED, DOUBLE-BLIND, SPLIT-FACE CLINICAL TRIAL

Chemical peels are resurfacing procedures where chemical agent causes controlled exfoliation of the skin, followed by regeneration and remodelling of the epidermis and dermis layers. Chemical peels can be used to treat various skin condition, such as skin aging, pigmentary disorders, and skin texture disorders. The use of moisturizer after chemical surgery can help speed up the wound healing process and repair the skin barrier. TCA chemical peel has more side effects than other chemical peel solutions. The risk of complications after TCA chemical surgery on Fitzpatrick IV-VI skin types is also higher, especially post-inflammatory hyperpigmentation. There is no specific recommendations regarding the type of moisturizer that can be used after TCA chemical peels. This study aims to assess the effectiveness of a cream containing spent grain wax, argan oil, and shea butter in reducing TCA peel side effects.

Study Overview

• Status: Completed
• Conditions: Aging Disorder
• Intervention / Treatment: Drug: Ezerra cream

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 4

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta, Indonesia, 10430
    • Faculty of Medicine Universitas Indonesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

women, 30 - 60 years old with facial skin aging underwent chemical peeling with TCA 15%, have received priming with topical retinoic acid 0.05%, for at least 2 weeks and its use has been discontinued three days before chemical peel.

Exclusion Criteria:

Pregnant or lactating women, patients who received hormonal therapy, immunosuppressants, allergic to any of treatment ingredients, had active skin diseases on the face (acne vulgaris, seborrheic dermatitis, dll), history of keloid/hypertrophic scar, open wound, active infection, or history of recurrent herpes simplex

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cream Containing Spent Grain Wax Extract, Argan Oil, and Shea Butter (Ezerra Cream); Ezerra cream The creams are applied to the face twice daily (0,5 Finger Tip Unit/FTU), immediately after washing. group A (intervention cream on the right side of the face and control cream on the left side of the face) and group B (intervention cream on the left side of the face and control cream on the right side of the face).	Drug: Ezerra cream; The research subjects were divided into 2 groups: group A (intervention cream on the right side of the face and control cream on the left side of the face) and group B (intervention cream on the left side of the face and control cream on the right side of the face). The test material consists of a cream containing a mixture of spent grain wax extract, shea butter, and argan oil, along with a vehicle cream. Vehicle cream was prepared by the Pharmacy Department of Faculty of Medicine Universitas Indonesia and has similar consistency, color, and scent as the intervention cream.The creams are applied to the face twice daily (0,5 FTU), immediately after washing, in equal amounts on each side of the face. The creams are applied for 7 days, and participants are instructed to use appropriate sunscreen.; Other Names: Vehicle cream
Placebo Comparator: Vehicle cream; Vehicle cream was prepared by the Pharmacy Department of Faculty of Medicine Universitas Indonesia and has similar consistency, color, and scent as the intervention cream. The creams are applied to the face twice daily (0,5 Finger Tip Unit/FTU), immediately after washing.	Drug: Ezerra cream; The research subjects were divided into 2 groups: group A (intervention cream on the right side of the face and control cream on the left side of the face) and group B (intervention cream on the left side of the face and control cream on the right side of the face). The test material consists of a cream containing a mixture of spent grain wax extract, shea butter, and argan oil, along with a vehicle cream. Vehicle cream was prepared by the Pharmacy Department of Faculty of Medicine Universitas Indonesia and has similar consistency, color, and scent as the intervention cream.The creams are applied to the face twice daily (0,5 FTU), immediately after washing, in equal amounts on each side of the face. The creams are applied for 7 days, and participants are instructed to use appropriate sunscreen.; Other Names: Vehicle cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Transepidermal water loss	Baseline (30 minutes after peeling), day 3, and day 7
Skin Capacitance	Baseline (30 minutes after peeling), day 3, and day 7
Erythema index	Baseline (30 minutes after peeling), day 3, and day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
global investigator assessment	comprised individual ratings of erythema, desquamation, edema, each on 4-point-scale (0-None; 1-Mild; 2-Moderate, 3-Severe	Baseline (30 minutes after peeling), day 3, and day 7
subject self-assessment	comprised individual ratings of erythema, desquamation, burning, pain, and itch, each on a 4-point-scale (0-None; 1-Mild; 2-Moderate, 3-Severe).	Baseline (30 minutes after peeling), day 3, and day 7

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: Dina Kusumawardhani, Indonesia University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): May 30, 2023
• Study Completion (Actual): June 4, 2023

Study Registration Dates

• First Submitted: February 4, 2024
• First Submitted That Met QC Criteria: February 12, 2024
• First Posted (Actual): February 13, 2024

Study Record Updates

• Last Update Posted (Actual): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: aging; trichloroacetic acid; anti-inflammation; skin aging; moisturizer; chemical peel
• Other Study ID Numbers: 23-02-0295

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No