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

NCT04253704 | Completed Phase 1 FDA Drug

• 1 other identifier: SYT.P0104-B1.B2
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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).

Conditions

Xerosis Cutis

Keywords

transepidermal water loss; skin hydration; vapometer; novameter

Outcome Measures

Primary Outcomes (2)

• Skin Hydration

  Change in skin hydration (NovaMeter assessment)

  Days 0, 7, 14 and 18

• Transepidermal water loss (TEWL)

  Change in transepidermal water loss (Vapometer assessment)

  Days 0, 14 and 18

Study Arms (2)

2% IDL lotion

EXPERIMENTAL

The left arm of each subject was used for the test material hydrating lotion (IDL).

Combination Product: IDL lotion

Control lotion

PLACEBO COMPARATOR

The right arm of each subject was used for control lotion lacking the IDL component.

Combination Product: Control lotion

Interventions

IDL lotion COMBINATION_PRODUCT

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%).

Also known as: IDL RC-02-38 / P0104-B1

2% IDL lotion

Control lotion COMBINATION_PRODUCT

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%).

Also known as: RC-02-38A / P0104-B2

Control lotion

Eligibility Criteria

• Age: 35 Years - 57 Years
• Gender Eligibility Details: Females only
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Females who were thirty-five to fifty-seven years of age.
• Individuals free of any dermatological or systemic disorder, which would have interfered with the results, at the discretion of the investigator.
• Individuals who had completed a preliminary medical history mandated by Cantor Research Laboratories, Inc.
• 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.
• Individuals who had abstained from the use of all moisturizing products for at least one week prior to treatment conditions.
• Individuals with known dry skin.

You may not qualify if:

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

Sponsors & Collaborators

• Shyla Cantor: lead
• Sytheon Ltd.: collaborator

Study Sites (1)

Cantor Research Laboratory

Blauvelt, New York, 10913, United States

Location

Related Links

• Cantor Research Laboratory Website
• Sytheon LTD Website

Study Officials

• Shyla Cantor, PhD

  Cantor Research Laboratory

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants were not told which arm received treatment versus placebo lotions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 30, 2020
• First Posted: February 5, 2020
• Study Start: February 13, 2017
• Primary Completion: March 3, 2017
• Study Completion: March 3, 2017
• Last Updated: February 5, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)