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

Johnson & Johnson (J&J)

Status: Completed

Conditions: Skin Cream; Skin; Skin Care

Treatments: Procedure: Regression; Other: Moisturizer B, F#E1387-004; Procedure: Non-Regression; Drug: Moisturizer A, F#9155-005

Study type: Interventional

Funder types: Industry

Identifiers

NCT04510103

PS-150914160029-SACT

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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46 participants in 2 patient groups

Regression Group

Other group

Description:

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).

Treatment:

Procedure: Regression

Drug: Moisturizer A, F#9155-005

Other: Moisturizer B, F#E1387-004

Non-Regression Group

Other group

Description:

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.

Treatment:

Procedure: Non-Regression

Drug: Moisturizer A, F#9155-005

Other: Moisturizer B, F#E1387-004