RecruitingNot ApplicableNCT06527066

Effect of Aromatherapy for Facial Aesthetics in Alleviating Signs of Aging: Pilot Study


Sponsor

University of Sao Paulo

Enrollment

38 participants

Start Date

Sep 16, 2024

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 45 YearsMax Age: 55 Years

Inclusion Criteria5

  • cisgender women;
  • 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 Criteria9

  • 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 before the beginning of participation;
  • use of cosmeceuticals seven to ten days before participating in the study, as well as during it, with only the use of photoprotector being permitted and recommended;
  • people who have undergone facial aesthetic surgery, except rhinoplasty.

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Interventions

COMBINATION_PRODUCTGeranium (Pelargonium graveolens) essential oil (EO) diluted to 1% in All.me Beauty® Gel Sérum Biocompatível

Volunteers must use a total of one gram of the formulation on their face, twice a day, in the morning and at night. The total duration of the protocol will be 12 weeks, with assessment of the participants' skin conditions, in relation to the item "Instrumental Facial Assessment", before treatment and after four, eight and 12 weeks.

OTHERGel Sérum Biocompatível All.me Beauty®

Volunteers must use a total of one gram of the formulation on their face, twice a day, in the morning and at night. The total duration of the protocol will be 12 weeks, with assessment of the participants' skin conditions, in relation to the item "Instrumental Facial Assessment", before treatment and after four, eight and 12 weeks.


Locations(1)

University of Sao Paulo Nursing School

São Paulo, São Paulo, Brazil

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NCT06527066


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