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
Verified date | January 2020 |
Source | Sytheon Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 16 |
Est. completion date | March 3, 2017 |
Est. primary completion date | March 3, 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 35 Years to 57 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Cantor Research Laboratory | Blauvelt | New York |
Lead Sponsor | Collaborator |
---|---|
Shyla Cantor | Sytheon Ltd. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Skin Hydration | Change in skin hydration (NovaMeter assessment) | Days 0, 7, 14 and 18 | |
Primary | Transepidermal water loss (TEWL) | Change in transepidermal water loss (Vapometer assessment) | Days 0, 14 and 18 |
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