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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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06255431
Enrollment
27
Registered
2024-02-13
Start date
2023-05-01
Completion date
2023-06-04
Last updated
2024-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging Disorder

Keywords

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

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.

Interventions

DRUGEzerra 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.

Sponsors

Indonesia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

double-blinded

Intervention model description

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

Eligibility

Sex/Gender
FEMALE
Age
30 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Transepidermal water lossBaseline (30 minutes after peeling), day 3, and day 7
Skin CapacitanceBaseline (30 minutes after peeling), day 3, and day 7
Erythema indexBaseline (30 minutes after peeling), day 3, and day 7

Secondary

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

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026