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

NCT04510103 | Completed

• 1 other identifier: PS-150914160029-SACT
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Skin; Skin Care; Skin Cream

Keywords

Skin; Stratum Corneum; Skin Care; Skin Cream; Dryness; Moisturization; Hydration

Outcome Measures

Primary Outcomes (1)

• Mean Change from Baseline to Week 6 in Clinical Grading of Skin Dryness

  The investigator assessed each of the subject's lower legs for skin dryness on a scale of 0 (no dryness) to 4 (severe scaling/fissuring). Half-points allowed.

  Baseline to Week 6

Secondary Outcomes (59)

• Mean Change from Baseline to Week 2 in Clinical Grading of Skin Dryness

  Baseline to Week 2

• Mean Change from Baseline to Week 4 in Clinical Grading of Skin Dryness

  Baseline to Week 4

• Mean Change from Regression Baseline to Regression Day 1 in Clinical Grading of Skin Dryness

  Regression Baseline to Regression Day 1

• Mean Change from Regression Baseline to Regression Day 4 in Clinical Grading of Skin Dryness

  Regression Baseline to Regression Day 4

• Mean Change from Regression Baseline to Regression Day 7 in Clinical Grading of Skin Dryness

  Regression Baseline to Regression Day 7

Study Arms (2)

Regression Group

OTHER

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).

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

Non-Regression Group

OTHER

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.

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

Interventions

Moisturizer A, F#9155-005 DRUG

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

Non-Regression Group; Regression Group

Moisturizer B, F#E1387-004 OTHER

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

Non-Regression Group; Regression Group

Regression PROCEDURE

2 week regression period after 6 weeks of moisturizer use.

Regression Group

Non-Regression PROCEDURE

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

Non-Regression Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johnson & Johnson Consumer Inc. (J&JCI): lead

Study Sites (1)

Thomas J. Stephens & Associates, Inc.

Colorado Springs, Colorado, 80915, United States

Location

Study Officials

• Neena Tierney

  Johnson & Johnson Consumer Inc. (J&JCI)

  STUDY DIRECTOR

• Kun "Mark" Qian, M.D.

  Thomas J. Stephens & Associates, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: August 12, 2020
• Study Start: October 23, 2015
• Primary Completion: March 25, 2016
• Study Completion: April 7, 2016
• Last Updated: August 12, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)