NCT06527066 Effect of Aromatherapy for Facial Aesthetics in Alleviating Signs of Aging: Pilot Study
| NCT ID | NCT06527066 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Sao Paulo |
| Condition | Aging Well |
| Study Type | INTERVENTIONAL |
| Enrollment | 38 participants |
| Start Date | 2024-09-16 |
| Primary Completion | 2025-06 |
Trial Parameters
Eligibility Fast-Check
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Brief 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 38 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 and Cutometer® Dual MPA 580.
Eligibility Criteria
Inclusion Criteria: * cisgender women; * 45 to 55 years old; * classification of II and III on the Glogau Scale; * agree to participate in the research considering the conditions and stages of the study protocol; * do not present adverse reactions to the topical use of the essential oil and its carrier base. Exclusion Criteria: * pregnant women; * breastfeeding women; * people diagnosed with neurological, serious dermatological diseases and others serious illnesses; * people with facial injuries; * severe allergies or occurrence of serious adverse events due to the use of cosmetics and/or cosmeceuticals in the past; * participants who present an allergic reaction during the allergenicity test and/or during the study; * those who underwent aesthetic facial procedures with fillers (except lip fillers) and botulinum toxin up to 6 months before the start of the protocol, PDO threads up to 3 months before, and chemical, mechanical and laser peelings, as well as microneedling, up to 1 month