Effect of Aromatherapy for Facial Aesthetics in Alleviating Signs of Aging: Pilot Study
NCT Number: NCT06527066
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Aging Well
Interventions: COMBINATION_PRODUCT: Geranium (Pelargonium graveolens) essential oil (EO) diluted to 1% in All.me Beauty® Gel Sérum Biocompatível|OTHER: Gel Sérum Biocompatível All.me Beauty®
Sponsor: University of Sao Paulo
Collaborators: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Sex: FEMALE
Age: ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2026-04

Summary:
Introduction: aesthetics is one of the specialties for professional nurses and presents a dialogue with Aromatherapy, a practice that uses essential oils (EO) from aromatic plants, being one of the most used integrative therapies for beauty care, youth and well-being. EOs are volatile compounds extracted from the most diverse parts of plants and some, such as geranium (Pelargonium graveolens), have antioxidant action, acting in the regeneration and maintenance of skin tissue, becoming a potential ally in the prevention and/or treatment of wrinkles, as well as general skin aging. Several anti-aging strategies are available, but consumers in aesthetics have increasingly prioritized their health and well-being, desiring non-invasive products and treatments, of natural origin, that guarantee safety and effectiveness. Objective: to evaluate the effect of Aromatherapy in alleviating the signs of aging on the facial skin of women, through a protocol of topical facial application, twice a day, with geranium EO (Pelargonium graveolens) diluted at 1% in Biocompatible Serum Gel All.me Beauty. Method: pilot study with a Randomized Clinical Trial (RCT) design, using the Consolidated Standards of Reporting Trials (CONSORT) as a reference, in its extension to randomized pilot and feasibility trials, double-blind (researcher and statistician). The sample will consist of 80 participants, estimating a loss of 10% throughout the study, who will be randomized between the Placebo Group (G1), whose treatment will be with pure use of the carrier base, and Intervention Group (G2), whose treatment will be with geranium EO diluted to 1% in All.me Beauty® Biocompatible Serum Gel. Participants must perform self-application at home, following a determined protocol and the intervention will respect a standard, in accordance with the guidelines of the manufacturer of the equipment used to measure the participants' progress in terms of wrinkles, hydration and elasticity of the facial skin, these being: Visioscan ® VC 20 Plus, Corneometer® CM 825, Tewameter® ™ Hex and Cutometer® Dual MPA 580.

Primary Outcome Measures: Facial wrinkles, Reduction of facial wrinkles using the Visioscan® VC 20 Plus as an assessment instrument, 12 weeks|Facial skin hydration, Increased facial skin hydration using the Corneometer® CM 825 and Tewameter® ™ Hex as measurement evaluation instruments, 12 weeks|Facial skin elasticity, Improvement of facial skin elasticity using the Cutometer® Dual MPA 580 as a measurement evaluation instrument, 12 weeks