Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06527066
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-12
Brief Title:
Effect of Aromatherapy for Facial Aesthetics in Alleviating Signs of Aging Pilot Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Aromatherapy for Facial Aesthetics in Alleviating Signs of Aging Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 Allme 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 Allme 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 participantsamp39 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
Detailed Description:
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 Allme Beauty Gel Sérum Biocompatível to be applied to the participantamp39s cubital fossa region with the aim of to rule out hypersensitivity reactions
After waiting at least 24 hours for the test to take place excluding immediate and late reactions a new face-to-face appointment will be scheduled for those who did not manifest any type of adverse reaction proceeding with the signing of the Terms of Reference Free and Informed Consent and full completion of the Clinical Assessment Form prepared electronically using Research Electronic Data Capture - REDCap Brasil and completed by the researcher using electronic equipment such as a cell phone tablet or notebook
The form includes questions pertinent to facial aesthetic treatments lifestyle habits clinical history non-instrumental facial assessment and instrumental facial assessment In the latter the condition of the participantamp39s facial skin will be analyzed in terms of wrinkles degree of hydration and elasticity using the instruments Visioscan VC 20 Plus wrinkles Corneometer CM 825 and Cutometer Dual MPA 580 elasticity
SAMPLE
The sample calculation was carried out based on the result obtained by the R2 parameter of the Cutometer Dual MPA 580 equipment which is capable of measuring skin elasticity achieved in the work of Tumsutti et al 2021 with a similar design and theme The sample was sized so that an effect size f 07055230 is detected in an ANOVA model for repeated measures with type I and II errors of 5 Under these conditions the minimum sample required is 35 participants in total Estimating a loss of 10 by the end of the intervention a total of 38 women will be considered to be distributed between the Placebo Group G1 and the Intervention Group G2
STUDY LOCATION
All assessments will be carried out by the researcher in person in a private office at the Center for Nursing Laboratories in Teaching Skills Simulation and Research at School of Nursing of the University of São Paulo
RANDOMIZATION
An independent statistician will carry out the randomization using a randomized table generated by a computer program and identified by a numerical code The list with the random numbers and names of the participants will be packed in opaque envelopes numbered and sealed by a professional external to the investigation The envelopes will be drawn and opened by a third professional external to the research who will be responsible for distributing each participant into their randomized group
INTERVENTION
G1 will be composed of those whose intervention will only be with the carrier base the Allme 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 Allme 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 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 4662012
Both the geranium EO Pelargonium graveolens and its carrier base must present a report describing its components and in relation to the EO its degree of purity The preparation and dilution will be done in a microbiological testing laboratory at School of Nursing of the University of São Paulo and the formulations will be stored in a round plastic bottle with a screw cap accompanied by a measuring spoon also made of plastic The formulation which must be stored away from light humidity and heat will be distributed to participants for self-application at home following the Application and Storage Protocol
Volunteers must use a total of one gram of the formulation on their face twice a day in the morning and at night The amount and method of application will be demonstrated at the first meeting and in a video to be prepared by the researcher which will be sent to the participants There will be no association with any other technique so that there is no bias in the results obtained
The type and brand of facial soap for routine home use will be evaluated as well as the photoprotector requiring the use of formulations that do not contain anti-aging active ingredients for the face and in relation to the photoprotector the additional requirement of not presenting pigmentation which constitutes as an extra layer of protection
To minimize or avoid interference in measurements assessments will respect a pre-established standard immediately before each assessment the participant must clean her face with water and neutral liquid soap provided by the researcher and then wait 20 minutes at rest for acclimatization in a controlled environment with a thermometer and hygrometer to measure environmental temperature and humidity Assessments will be carried out during the day at a fixed time and place under indirect natural lighting and participants will be instructed to appear without makeup
The total duration of the protocol will be 12 weeks with assessment of the participantsamp39 skin conditions with regard to the item Instrumental Facial Assessment before treatment and after four eight and 12 weeks according to thematic and similar drawings At each in-person assessment and therefore once a month during the three months of treatment the participant will be given a vial unit containing 60 grams of the formulation
At the end of the intervention volunteers must respond to a Final Questionnaire also made with RedCap where they will be able to explain their impressions regarding the characteristics and performance of the product such as odor consistency and effectiveness in addition to impressions regarding the appearance of the product own skin
ASSESSMENT INSTRUMENTS
There are several techniques used in RCTs to evaluate the effectiveness of cosmeceutical treatments with formulations of plant origin or not in terms of reducing wrinkles and improving skin hydration and elasticity and most of them have worked with the following instruments subject to their updates which will be made available for this study by the company Tecnotests Produtos e Serviços Ltda
Visioscan VC 20 Plus - Skin topography assessment of wrinkles in the upper and middle thirds of the face forehead eyelid cheek junction and jowls only on the left side of the face By digitizing the image obtained by a video sensor it allows the evaluation of the skin surface obtaining the following clinical parameters SEr - skin roughness determined by the presence of dark spots SEw - number and width of wrinkles this value being greater or lesser according to the number of wrinkles SEsm - skin softness with a higher value of this variable being an indication of better skin texture and softness SEsc - skin peeling
Corneometer CM 825 - assessment of hydration in the upper and middle thirds of the face forehead eyelid cheek junction and jowls only on the left side of the face its measurement principle is the capacitance of a precision capacitor in a dielectric medium where changes in the dielectric constant in relation to the variation in hydration of the epidermis changes the capacitance The measurement is capable of detecting even the smallest changes in the level of hydration without being influenced by the deeper layers of the skin by maintaining its range between 10 and 20 µm from the stratum corneum
Cutometer Dual MPA 580 - Skin viscoelasticity assessment of elasticity in the lower third of the face forehead eyelid cheek junction and jowls only on the left side of the face The measuring principle is based on suction created by negative pressure between the instrument and the skin The depth of skin penetration is determined by an optical system composed of a light receptor whose intensity varies according to the depth of suction The resistance that the skin exerts against suction due to negative pressure represents its firmness and its action of returning to the original position elasticity both represented in graphs with curves also presenting several parameters represented by the letters R F and Q
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 Allme Beauty Gel Sérum Biocompatível to be applied to the participantamp39s cubital fossa region with the aim of to rule out hypersensitivity reactions
After waiting at least 24 hours for the test to take place excluding immediate and late reactions a new face-to-face appointment will be scheduled for those who did not manifest any type of adverse reaction proceeding with the signing of the Terms of Reference Free and Informed Consent and full completion of the Clinical Assessment Form prepared electronically using Research Electronic Data Capture - REDCap Brasil and completed by the researcher using electronic equipment such as a cell phone tablet or notebook
The form includes questions pertinent to facial aesthetic treatments lifestyle habits clinical history non-instrumental facial assessment and instrumental facial assessment In the latter the condition of the participantamp39s facial skin will be analyzed in terms of wrinkles degree of hydration and elasticity using the instruments Visioscan VC 20 Plus wrinkles Corneometer CM 825 and Cutometer Dual MPA 580 elasticity
SAMPLE
The sample calculation was carried out based on the result obtained by the R2 parameter of the Cutometer Dual MPA 580 equipment which is capable of measuring skin elasticity achieved in the work of Tumsutti et al 2021 with a similar design and theme The sample was sized so that an effect size f 07055230 is detected in an ANOVA model for repeated measures with type I and II errors of 5 Under these conditions the minimum sample required is 35 participants in total Estimating a loss of 10 by the end of the intervention a total of 38 women will be considered to be distributed between the Placebo Group G1 and the Intervention Group G2
STUDY LOCATION
All assessments will be carried out by the researcher in person in a private office at the Center for Nursing Laboratories in Teaching Skills Simulation and Research at School of Nursing of the University of São Paulo
RANDOMIZATION
An independent statistician will carry out the randomization using a randomized table generated by a computer program and identified by a numerical code The list with the random numbers and names of the participants will be packed in opaque envelopes numbered and sealed by a professional external to the investigation The envelopes will be drawn and opened by a third professional external to the research who will be responsible for distributing each participant into their randomized group
INTERVENTION
G1 will be composed of those whose intervention will only be with the carrier base the Allme 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 Allme 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 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 4662012
Both the geranium EO Pelargonium graveolens and its carrier base must present a report describing its components and in relation to the EO its degree of purity The preparation and dilution will be done in a microbiological testing laboratory at School of Nursing of the University of São Paulo and the formulations will be stored in a round plastic bottle with a screw cap accompanied by a measuring spoon also made of plastic The formulation which must be stored away from light humidity and heat will be distributed to participants for self-application at home following the Application and Storage Protocol
Volunteers must use a total of one gram of the formulation on their face twice a day in the morning and at night The amount and method of application will be demonstrated at the first meeting and in a video to be prepared by the researcher which will be sent to the participants There will be no association with any other technique so that there is no bias in the results obtained
The type and brand of facial soap for routine home use will be evaluated as well as the photoprotector requiring the use of formulations that do not contain anti-aging active ingredients for the face and in relation to the photoprotector the additional requirement of not presenting pigmentation which constitutes as an extra layer of protection
To minimize or avoid interference in measurements assessments will respect a pre-established standard immediately before each assessment the participant must clean her face with water and neutral liquid soap provided by the researcher and then wait 20 minutes at rest for acclimatization in a controlled environment with a thermometer and hygrometer to measure environmental temperature and humidity Assessments will be carried out during the day at a fixed time and place under indirect natural lighting and participants will be instructed to appear without makeup
The total duration of the protocol will be 12 weeks with assessment of the participantsamp39 skin conditions with regard to the item Instrumental Facial Assessment before treatment and after four eight and 12 weeks according to thematic and similar drawings At each in-person assessment and therefore once a month during the three months of treatment the participant will be given a vial unit containing 60 grams of the formulation
At the end of the intervention volunteers must respond to a Final Questionnaire also made with RedCap where they will be able to explain their impressions regarding the characteristics and performance of the product such as odor consistency and effectiveness in addition to impressions regarding the appearance of the product own skin
ASSESSMENT INSTRUMENTS
There are several techniques used in RCTs to evaluate the effectiveness of cosmeceutical treatments with formulations of plant origin or not in terms of reducing wrinkles and improving skin hydration and elasticity and most of them have worked with the following instruments subject to their updates which will be made available for this study by the company Tecnotests Produtos e Serviços Ltda
Visioscan VC 20 Plus - Skin topography assessment of wrinkles in the upper and middle thirds of the face forehead eyelid cheek junction and jowls only on the left side of the face By digitizing the image obtained by a video sensor it allows the evaluation of the skin surface obtaining the following clinical parameters SEr - skin roughness determined by the presence of dark spots SEw - number and width of wrinkles this value being greater or lesser according to the number of wrinkles SEsm - skin softness with a higher value of this variable being an indication of better skin texture and softness SEsc - skin peeling
Corneometer CM 825 - assessment of hydration in the upper and middle thirds of the face forehead eyelid cheek junction and jowls only on the left side of the face its measurement principle is the capacitance of a precision capacitor in a dielectric medium where changes in the dielectric constant in relation to the variation in hydration of the epidermis changes the capacitance The measurement is capable of detecting even the smallest changes in the level of hydration without being influenced by the deeper layers of the skin by maintaining its range between 10 and 20 µm from the stratum corneum
Cutometer Dual MPA 580 - Skin viscoelasticity assessment of elasticity in the lower third of the face forehead eyelid cheek junction and jowls only on the left side of the face The measuring principle is based on suction created by negative pressure between the instrument and the skin The depth of skin penetration is determined by an optical system composed of a light receptor whose intensity varies according to the depth of suction The resistance that the skin exerts against suction due to negative pressure represents its firmness and its action of returning to the original position elasticity both represented in graphs with curves also presenting several parameters represented by the letters R F and Q
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None