Effects of 2% IDL Lotion on Skin Hydration and Transepidermal Water Loss in Females With Dry Skin
Condition: Xerosis Cutis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      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).
    

Detailed description: 
      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).
    

Intervention name(s): IDL lotion; Control lotion
Intervention type(s): Combination Product; Combination Product
Intervention description(s): IDL lotion is water-based (> 80%) with isosorbide di-(linoleate/oleate) (2.0%), caprylic/capric triglycerides (5%), glycerin (3%), glyceryl stearate (2.5%), dimethicone (2.0%), steareth-20 (1.5%), cetyl alcohol (1.0%), and butyrospermum parkii (shea) butter (1.0%).; Control lotion is water-based (> 80%) with caprylic/capric triglycerides (5%), glycerin (3%), glyceryl stearate (2.5%), dimethicone (2.0%), steareth-20 (1.5%), cetyl alcohol (1.0%), and butyrospermum parkii (shea) butter (1.0%).
Other intervention name(s): IDL RC-02-38 / P0104-B1; RC-02-38A / P0104-B2
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Test materials were applied to forearm skin of each subject. The left arm was used for the test material IDL lotion. The right arm was used for the hydrating control lotion.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: transepidermal water loss; skin hydration; vapometer; novameter