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
|Condition or disease||Intervention/treatment||Phase|
|Xerosis Cutis||Combination Product: IDL lotion Combination Product: Control lotion||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|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.|
|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|
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
- Skin Hydration [ Time Frame: Days 0, 7, 14 and 18 ]Change in skin hydration (NovaMeter assessment)
- Transepidermal water loss (TEWL) [ Time Frame: Days 0, 14 and 18 ]Change in transepidermal water loss (Vapometer assessment)
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
|United States, New York|
|Cantor Research Laboratory|
|Blauvelt, New York, United States, 10913|
|Study Director:||Shyla Cantor, PhD||Cantor Research Laboratory|