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

NCT06255431 | Completed Phase 4

• 1 other identifier: 23-02-0295
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aging Disorder

Keywords

aging; skin aging; trichloroacetic acid; chemical peel; anti-inflammation; moisturizer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• global investigator assessment

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

• subject self-assessment

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

Study Arms (2)

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

ACTIVE COMPARATOR

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

Vehicle cream

PLACEBO COMPARATOR

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

Interventions

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.

Also known as: Vehicle cream

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

Eligibility Criteria

• Age: 30 Years - 60 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Faculty of Medicine Universitas Indonesia

Jakarta, 10430, Indonesia

Location

Study Officials

• Dina Kusumawardhani

  Indonesia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blinded
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr.

Model Details: A randomized, placebo-controlled, double-blinded, split face trial on women undergoing TCA 15% chemical peels.

Study Record Dates

• First Submitted: February 4, 2024
• First Posted: February 13, 2024
• Study Start: May 1, 2023
• Primary Completion: May 30, 2023
• Study Completion: June 4, 2023
• Last Updated: February 13, 2024

Record last verified: 2024-02

Locations

ID (1)