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Effects of 2% IDL Lotion on Skin Hydration and Transepidermal Water Loss in Females With Dry Skin

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ClinicalTrials.gov Identifier: NCT04253704
Recruitment Status : Completed
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Collaborator:
Sytheon Ltd.
Information provided by (Responsible Party):
Shyla Cantor, Sytheon Ltd.

Brief 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).

Condition or disease Intervention/treatment Phase
Xerosis Cutis Combination Product: IDL lotion Combination Product: Control lotion Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
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)
Masking Description: Participants were not told which arm received treatment versus placebo lotions.
Primary Purpose: Treatment
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
Actual Study Start Date : February 13, 2017
Actual Primary Completion Date : March 3, 2017
Actual Study Completion Date : March 3, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

Arm Intervention/treatment
Experimental: 2% IDL lotion
The left arm of each subject was used for the test material hydrating lotion (IDL).
Combination Product: IDL lotion
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%).
Other Name: IDL RC-02-38 / P0104-B1

Placebo Comparator: Control lotion
The right arm of each subject was used for control lotion lacking the IDL component.
Combination Product: Control lotion
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 Name: RC-02-38A / P0104-B2




Primary Outcome Measures :
  1. Skin Hydration [ Time Frame: Days 0, 7, 14 and 18 ]
    Change in skin hydration (NovaMeter assessment)

  2. Transepidermal water loss (TEWL) [ Time Frame: Days 0, 14 and 18 ]
    Change in transepidermal water loss (Vapometer assessment)



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Ages Eligible for Study:   35 Years to 57 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Females only
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Females who were thirty-five to fifty-seven years of age.
  2. Individuals free of any dermatological or systemic disorder, which would have interfered with the results, at the discretion of the investigator.
  3. Individuals who had completed a preliminary medical history mandated by Cantor Research Laboratories, Inc.
  4. Individuals who had read, understood and signed an informed consent document as required by Reference 21 CFR Ch. 1 Part 50, Subpart B. Consent forms are kept on file and are available for examination on the premises of Cantor Research Laboratories, Inc., only.
  5. Individuals who had abstained from the use of all moisturizing products for at least one week prior to treatment conditions.
  6. Individuals with known dry skin.

Exclusion Criteria:

  1. Individuals who were under doctor's care.
  2. Individuals who were taking medication, which in the opinion of the investigator would have masked or interfered with the results.
  3. Individuals with chronic skin allergies.
  4. Females who were pregnant or lactating.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04253704


Locations
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United States, New York
Cantor Research Laboratory
Blauvelt, New York, United States, 10913
Sponsors and Collaborators
Shyla Cantor
Sytheon Ltd.
Investigators
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Study Director: Shyla Cantor, PhD Cantor Research Laboratory
Additional Information:
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Responsible Party: Shyla Cantor, Principal Investigator, Sytheon Ltd.
ClinicalTrials.gov Identifier: NCT04253704    
Other Study ID Numbers: SYT.P0104-B1.B2
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be published in a scientific journal with raw data made available to researchers upon request.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Shyla Cantor, Sytheon Ltd.:
transepidermal water loss
skin hydration
vapometer
novameter