Effect of Aromatherapy for Facial Aesthetics in Alleviating Signs of Aging: Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Facial wrinkles
研究概览
简要总结
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.
详细描述
STUDY
This is a Pilot Study with a Randomized Clinical Trial (RCT) design, using the Consolidated Standards of Reporting Trials (CONSORT) as a reference for reporting the study, in its extension for randomized pilot and feasibility trials, double-blind (researcher and statistician), it was not possible to blind the participants, since the geranium EO (Pelargonium graveolens) has a characteristic aroma.
RECRUITMENT
Participants will be recruited by disseminating the research at the Institute of Integrated and Oriental Therapy, at the School of Nursing of the University of São Paulo and also by snowballing to employees of other units of the university. Interested parties will access a page containing explanatory text with a summary of the study and a link to fill out the Screening Form, prepared via Google Forms, and referring to the exclusion criteria.
For eligible interested parties, an in-person assessment will be scheduled to carry out the topical tolerability test with geranium EO diluted at 1%, in All.me Beauty® Gel Sérum Biocompatível, to be applied to the participant's cubital fossa region, with the aim of to rule out hypersensitivity reactions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 45 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Placebo Group (G1)
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.
干预措施: Gel Sérum Biocompatível All.me Beauty® (Other)
Intervention Group (G2)
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.
干预措施: Geranium (Pelargonium graveolens) essential oil (EO) diluted to 1% in All.me Beauty® Gel Sérum Biocompatível (Combination Product)
结局指标
主要结局
Facial wrinkles
时间窗: 12 weeks
Reduction of facial wrinkles using the Visioscan® VC 20 Plus as an assessment instrument
Facial skin elasticity
时间窗: 12 weeks
Improvement of facial skin elasticity using the Cutometer® Dual MPA 580 as a measurement evaluation instrument
Facial skin hydration
时间窗: 12 weeks
Increased facial skin hydration using the Corneometer® CM 825
次要结局
未报告次要终点
研究者
Amanda Karina Santos Vieira
Principal Investigator
University of Sao Paulo