Skip to main content
OpenTrials
Completed

NCT Number: NCT06255431

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Aging Disorder

Age range

30 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Medicine Universitas Indonesia

Jakarta, 10430, Indonesia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ezerra cream

Drug

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

Primary outcomes

  1. Transepidermal water loss

    Time frame: Baseline (30 minutes after peeling), day 3, and day 7

  2. Skin Capacitance

    Time frame: Baseline (30 minutes after peeling), day 3, and day 7

  3. Erythema index

    Time frame: Baseline (30 minutes after peeling), day 3, and day 7

Secondary outcomes

  1. global investigator assessment

    Time frame: Baseline (30 minutes after peeling), day 3, and day 7

    comprised individual ratings of erythema, desquamation, edema, each on 4-point-scale (0-None; 1-Mild; 2-Moderate, 3-Severe

  2. subject self-assessment

    Time frame: Baseline (30 minutes after peeling), day 3, and day 7

    comprised individual ratings of erythema, desquamation, burning, pain, and itch, each on a 4-point-scale (0-None; 1-Mild; 2-Moderate, 3-Severe).

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 13, 2024
Registry last updated
Feb 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.