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
- Conditions
- Aging Disorder
- Interventions
- Drug: Ezerra cream
- Registration Number
- NCT06255431
- Lead Sponsor
- Indonesia University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 27
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.
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Cream Containing Spent Grain Wax Extract, Argan Oil, and Shea Butter (Ezerra Cream) 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). Vehicle cream Ezerra 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method global investigator assessment 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
subject self-assessment 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).
Trial Locations
- Locations (1)
Faculty of Medicine Universitas Indonesia
🇮🇩Jakarta, Indonesia