Xerosis Cutis Clinical Trial
Official title:
Placebo-controlled Double-blinded Trial to Evaluate the Effects of Short-term (1-2 Weeks) Treatment With 2% (Isosorbide di-(Linoleate/Oleate)) (IDL) Lotion on Skin Hydration and Transepidermal Water Loss in Females With Dry Skin
This was a placebo-controlled double-blinded trial to compare effects of 2% IDL lotion to placebo in female subjects with dry skin. Primary endpoints were skin hydration (NovaMeter) and transepidermal water loss (VapoMeter).
1. Objective: To evaluate the efficacy of two topically applied test materials and the
ability to increase hydration and decrease the transepidermal water loss of the skin.
Efficacy was evaluated instrumentally using the NovaMeter and VapoMeter.
2. Test Material Description: On January 4, 2017, two test samples labeled Hydrating Lotion
HydraSynol IDL RC-02-38, 12/21/16 and Hydrating Lotion Control RC-02-38A, 12/21/16 were
received from Sytheon Ltd. and assigned CR Lab Nos.: P0104-B1 and P0104-B2,
respectively.
3. Test Material Handling: Upon arrival at Cantor Research Laboratories, Inc., the test
materials were assigned a unique laboratory code number and entered into a daily log
identifying the lot number, sample description, sponsor, date received and tests
requested. Samples are retained for a period of three months beyond submission of final
report unless otherwise specified by the sponsor or if sample is known to be in support
of governmental applications, in which case retained samples are kept two years beyond
final report submission. Sample disposal is conducted in compliance with appropriate
federal, state and local ordinances.
4. Recruitment: Panel selection was accomplished by advertisements in local periodicals,
community bulletin boards, phone solicitation, electronic media or any combination
thereof.
5. Informed Consent: In compliance with 21 CFR Ch.1 Part 50, Subpart B, informed consent
was obtained from each volunteer prior to the commencement of the study. The consent
form described the procedures, possible adverse effects, associated risks, and potential
benefits of the study and the limits of liability. Panelists signed and dated the
informed consent document to indicate their authorization to proceed and acknowledge
their understanding of the contents.
6. NovaMeter: The Novameter is a multifunctional electronic laboratory instrument that
measures skin impedance. It is designed to provide non-invasive, objective, reproducible
method of measurement to quantify biophysical characteristics and relative hydration of
the skin.
7. VapoMeter: The VapoMeter is a fully portable instrument for measureing TEWL
(transepidermal water loss) values and evaporation rates. TEWL is an indicator of the
skin's barrier function. The core of the VapoMeter is a sensitive humidity sensor that
is inside a cylindrical measurement chamber. This chamber is closed by the skin or other
measurement surface during the measurement period and is unaffected by ambient airflows.
The sensor monitors the increase of relative humidity (RH) inside the chamber during the
measurement. The evaporation rate value (g/m²h) is automatically calculated from the RH
increase. The chamber is passively ventilated between measurements and the ventilation
time is automatically controlled. The VapoMeter is widely accepted and an efficient
instrument for TEWL measurements.
8. Washout period: Five days prior to the study the panelists were told to not use any
moisturizers or treatment products on their arms and refrain from using any other
products during the course of the study. They were asked to wash their arms with only
ivory soap and pat dry.
9. Baseline: The panelists arrived at the lab with their arms washed by water alone (if
forearm skin was not dry, the panelist was asked to wash their arms with only ivory soap
and pat dry). Panelists with Skin Dryness Grade of 6 and 7 were inducted in the study. A
trained technician examined the test areas (left and right volar arms) for any
abnormalities that would obstruct the measurements. The left arm was used for the test
material Hydrating Lotion HydraSynol IDL RC-02-38, 12/21/16 (CR Lab No. P0104-B1). The
right arm was used for Hydrating Lotion Control RC-02-38A, 12/21/16 (CR Lab No.
P0104-B2). The panelists were required to equilibrate to the controlled environment with
a constant temperature of 70 degrees F and humidity of 30% Rh for half hour.
Measurements on each arm (left and right volar arms) were taken using the NovaMeter and
VapoMeter. A trained technician then applied each test material to the respective volar
arm in order for the panelist to observe the manner in which the products should be
applied for two weeks. The test materials were allowed to dry before the dismissal of
the panelist. The panelists were then given the pre weighed test materials as well as a
study diary in order to list the time of each application, the date and any subjective
comments that they might have about the test materials.
10. Week 2: The panelists arrived at the lab with their arms applied with the test materials
at least five hours prior. A trained technician examined the test areas (left and right
volar arms) for any abnormalities that would obstruct the measurements. The panelists
were allowed to equilibrate to the controlled environment with a constant temperature of
70 degrees F and humidity of 30% Rh for a half hour. Measurements on each arm (left and
right volar arms) were taken again using the NovaMeter and VapoMeter. The test materials
were weighed and diaries collected to check for compliance.
11. Day 18 (after 4 days regression): The panelists arrived at the lab. A trained technician
examined the test areas (left and right volar arms) for any abnormalities that would
obstruct the measurements. The panelists were allowed to equilibrate to the controlled
environment with a constant temperature of 70 degrees F and humidity of 30% Rh for a
half hour. Measurements on each arm (left and right volar arms) were taken again using
the NovaMeter and VapoMeter.
12. Adverse reactions: Subjects were instructed to report any delayed reactions which might
occur after the final reading. Clients are notified immediately in the case of an
adverse reaction and a determination is made as to a treatment program if necessary.
13. Statistical Analysis: All of the data was tabulated in a Microsoft® Excel spreadsheet.
Using the t-Test, the statistical significance of the net change from baseline
(pre-application) to each subsequent time point was assessed. Statistical significance
was defined at the p=0.05 or less level (corresponding to a 95% or greater confidence
level).
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