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

NCT06527066 | Recruiting

• 1 other identifier: AVieira
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging Well

Keywords

Aesthetics; Complementary Therapies; Aromatherapy; Nursing

Outcome Measures

Primary Outcomes (3)

• Facial wrinkles

  Reduction of facial wrinkles using the Visioscan® VC 20 Plus as an assessment instrument

  12 weeks

• Facial skin elasticity

  Improvement of facial skin elasticity using the Cutometer® Dual MPA 580 as a measurement evaluation instrument

  12 weeks

• Facial skin hydration

  Increased facial skin hydration using the Corneometer® CM 825

  12 weeks

Study Arms (2)

Placebo Group (G1)

PLACEBO COMPARATOR

The Placebo Group (G1) will be composed of those whose intervention will only be with the carrier base, the All.me Beauty® Gel Sérum Biocompatível, which constitutes a way of diluting the EO and does not interfere with its action and therapeutic process, acting as a placebo.

Other: Gel Sérum Biocompatível All.me Beauty®

Intervention Group (G2)

EXPERIMENTAL

In the Intervention Group (G2) there will be participants who will receive intervention with geranium EO (Pelargonium graveolens), diluted in All.me Beauty® Gel Sérum Biocompatível, respecting a concentration of 1%, determined based on a work where tolerability was shown in the application of this 1% EO, on oral mucosa, for the treatment of denture stomatitis; For the present study, the sensitivities of the facial skin and smell were taken into account.

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

Interventions

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

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.

Intervention Group (G2)

Gel Sérum Biocompatível All.me Beauty® OTHER

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.

Placebo Group (G1)

Eligibility Criteria

• Age: 45 Years - 55 Years
• Gender Eligibility Details: Cisgender women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator

Study Sites (1)

University of Sao Paulo Nursing School

São Paulo, São Paulo, Brazil

RECRUITING

MeSH Terms

Interventions

Oils, Volatile

Intervention Hierarchy (Ancestors)

Oils; Lipids

Study Officials

• Amanda K S Vieira, Principal researcher

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda Vieira, Principal researcher

CONTACT

+55 94811-5623; amanda.karina.vieira@usp.br

Juliana Gnatta, Advisor

CONTACT

+55 99830-1758; juliana.gnatta@usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind (researcher and statistician), it was not possible to blind the participants, since the geranium EO (Pelargonium graveolens) has a characteristic aroma. The researcher/investigator is also the one who will provide care and evaluate the results.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: G1 will be composed of those whose intervention will only be with the carrier base, the All.me Beauty® Gel Sérum Biocompatível, which serves as a way of diluting the EO and does not interfere with its action and therapeutic process, acting as a placebo. In G2 there will be participants who will receive intervention with geranium EO (Pelargonium graveolens), diluted in All.me Beauty® Gel Sérum Biocompatível, respecting a concentration of 1%, determined based on the work of Sabzghabaee et al. (2011), where tolerability was shown in the application of this 1% EO, on oral mucosa, for the treatment of denture stomatitis; For the present study, the sensitivities of the facial skin and smell were taken into account. The intervention with geranium EO (Pelargonium graveolens) will be made available to G1 after the end of the study protocol, in consideration of the ethical precepts of research involving human beings, according to Resolution nº 466/2012.

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: July 30, 2024
• Study Start: September 16, 2024
• Primary Completion: June 1, 2025
• Study Completion: July 1, 2025
• Last Updated: February 7, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)