Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Aging Disorder
Keywords: aging
skin aging
trichloroacetic acid
chemical peel
anti-inflammation
moisturizer
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2024-02-13
Enrollment: 27
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: A randomized, placebo-controlled, double-blinded, split face trial on women undergoing TCA 15% chemical peels.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Transepidermal water loss
timeFrame: Baseline (30 minutes after peeling), day 3, and day 7
measure: Skin Capacitance
timeFrame: Baseline (30 minutes after peeling), day 3, and day 7
measure: Erythema index
timeFrame: Baseline (30 minutes after peeling), day 3, and day 7
Secondary outcomes:
measure: global investigator assessment
timeFrame: Baseline (30 minutes after peeling), day 3, and day 7
measure: subject self-assessment
timeFrame: Baseline (30 minutes after peeling), day 3, and day 7
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Faculty of Medicine Universitas Indonesia
Study officials:
affiliation: Indonesia University
name: Dina Kusumawardhani
role: PRINCIPAL_INVESTIGATOR
References: