A Controlled Clinical Study of 2 Different Moisturizers for the Relief of Dry Skin

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-23

Study Completion Date

2016-04-07

Brief Summary

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Dry skin is characterized by a lack of moisture in the outer layer of the skin and can occur as a result of numerous factors including cold weather, low humidity, age, etc. In this study, the moisturizing benefits of two formulas were evaluated for barrier function improvement/impact when used by women with moderately to severely dry skin on their lower legs.

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Detailed Description

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Conditions

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Skin Skin Care Skin Cream

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Subjects were assigned to one of two procedural groups (Regression or Non-Regression) based on Visit 1 scheduling. Subjects were provided with a commercial cleanser to use during a 3-day period with no moisturizers and no hair removal allowed on their lower legs, and to continue using throughout the study. At Visit 2, all subjects received the two test moisturizers to use split-leg (right vs. left lower leg randomized) to use for 6 weeks. Subjects returned for evaluations at Week 2 (Visit 3), Week 4 (Visit 4), and Week 6 (Visit 5). At Week 6, subjects in the Regression group entered a 2-week regression period (no moisturizer usage) and returned for evaluations at Regression Days 1, 4, 7, 10, and 14. Meanwhile, at Week 6, subjects in the Non-Regression group (exploratory) continued using the moisturizers; they returned for evaluations at Week 6 + Days 1, 2, 3, and 4.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

The test moisturizers were assigned a product code; each moisturizer was assigned to a subject's right or left lower leg per a randomization schedule. Subjects were blinded to the product identities, and evaluators were blinded to which product was used on each leg. Procedural group was unblinded and based on scheduling at Visit 1.

Study Groups

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Regression Group

The Regression Group received the two test moisturizers to use split-leg (right vs. left lower leg randomized) for 6 weeks and then entered a 2-week regression period (no moisturizer usage).

Group Type OTHER

Moisturizer A, F#9155-005

Intervention Type DRUG

OTC Monograph Drug. Used twice daily on left or right lower leg per randomization schedule.

Moisturizer B, F#E1387-004

Intervention Type OTHER

Cosmetic Moisturizer. Used twice daily on left or right lower leg per randomization schedule.

Regression

Intervention Type PROCEDURE

2 week regression period after 6 weeks of moisturizer use.

Non-Regression Group

The Non-Regression Group received the two test moisturizers to use split-leg (right vs. left lower leg randomized) for 6 weeks and then underwent a physical insult (tape stripping) on the lower legs and continued using the moisturizer for 4 additional days.

Group Type OTHER

Moisturizer A, F#9155-005

Intervention Type DRUG

OTC Monograph Drug. Used twice daily on left or right lower leg per randomization schedule.

Moisturizer B, F#E1387-004

Intervention Type OTHER

Cosmetic Moisturizer. Used twice daily on left or right lower leg per randomization schedule.

Non-Regression

Intervention Type PROCEDURE

Physical insult (tape stripping) on the lower leg after 6 weeks of moisturizer use.

Interventions

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Moisturizer A, F#9155-005

OTC Monograph Drug. Used twice daily on left or right lower leg per randomization schedule.

Intervention Type DRUG

Moisturizer B, F#E1387-004

Cosmetic Moisturizer. Used twice daily on left or right lower leg per randomization schedule.

Intervention Type OTHER

Regression

2 week regression period after 6 weeks of moisturizer use.

Intervention Type PROCEDURE

Non-Regression

Physical insult (tape stripping) on the lower leg after 6 weeks of moisturizer use.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* moderately to severely dry skin on both leg legs, as determined by the investigator.
* Fitzpatrick skin types I-IV
* generally in good health
* routinely uses moisturizers on the legs at least 1-3 times per week.
* if of reproductive potential: using a medically acceptable form of birth control for at least 3 months before the study and willing to continue it for at least 1 month after study completion.
* able to read, write, speak, and understand English.
* willing and able to complete all study instructions.
* has completed the informed consent document including a HIPAA disclosure and photograph release.

Exclusion Criteria

* known allergies/sensitivities to adhesive tapes or study product ingredients.
* known skin conditions, uncontrolled medical conditions, or any other condition that could interfere with evaluations/data interpretation or increase risk to the subject.
* any active bacterial/fungal/viral skin infections or susceptibility to such infections.
* females who are pregnant, breastfeeding, or planning to become pregnant in near future.
* compromised/broken skin, tattoos, scarring, excessive hair growth, very uneven skin tone, or other conditions that would interfere with evaluations or increase risk to the subject.
* current participation in another study.
* participation in another study in past 4 weeks.
* employees or relatives of the investigator or study site.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No