Clinical trial

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

Name

23-02-0295

Description

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.

Trial arms

Trial start

2023-05-01

Estimated PCD

2023-05-30

Trial end

2023-06-04

Status

Completed

Phase

Early phase I

Treatment

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.

Arms:

Cream Containing Spent Grain Wax Extract, Argan Oil, and Shea Butter (Ezerra Cream), Vehicle cream

Other names:

Vehicle cream

Size

Primary endpoint

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

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'A randomized, placebo-controlled, double-blinded, split face trial on women undergoing TCA 15% chemical peels.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'double-blinded', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 27, 'type': 'ACTUAL'}}

Updated at

2024-02-13

1 organization

1 product

1 indication

Organization

Indonesia University

Product

Ezerra

Indication

Aging Disorder