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.
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 participant's 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 = 0.7055230 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
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 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 466/2012.
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
participants' 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.