The Role of Skin Care Regimen in Skin Health

Johns Hopkins University

Status: Completed

Conditions: Itching; Xerosis

Treatments: Other: skin care regimen

Study type: Interventional

Funder types: Other

Identifiers

NCT03497130

IRB00165140

Details and patient eligibility

About

This research is being done to evaluate the role of a regular skin care regimen comprising of a mild soap and moisturizer in improving dry skin and overall skin health. In this study, the investigators hope to learn the importance of regular skin care regimen in improving dry skin and overall skin health.

Full description

Dry skin is a common phenomenon and can dramatically decrease a person's quality of life as well as contribute to a wide variety of skin diseases. Skin care products hydrate the skin and breaks the dry skin cycle. While there is extensive evidence of benefits of using mild cleansers and moisturizers, much of the previous studies are limited to the effects of single cleanser or moisturizer.

In this study, the investigators are going to enroll up to 100 people over the age of 18 with dry, itchy skin and they will be split into 2 groups. Participants will be randomly assigned to skin care regimen group (approximately 75% of total enrolled) and control group (approximately 25% of total enrolled). All evaluation include clinical assessments, subject questionnaires and photography will be conducted similarly in both groups.

Analysis will include paired and unpaired t-tests with two-tailed p-values. Values obtained at baseline, in middle of the study and after completing the study will be compared. The difference of measure values will be compared between application group and control group.

The moisturizing lotion and wash are generally very well tolerated.Rarely, they can induce a burning sensation, dryness, skin irritation, erythema, stinging, sensitization, and dermatitis. Risk events, problems, and deviations will be reported by the PI directly to the Institutional Review Boards.

The investigators hope to learn the importance of regular skin care regimen in improving dry skin and overall skin health.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants must be over the age of 18 years old with dry, itchy skin;
• Participant must be willing to comply with the requirements of the protocol;
• Participant must have the ability to understand and communicate with the investigator;
• Participant must provide informed consent.

Exclusion criteria

• Subjects who are unable to provide informed consent;
• Subjects who are unable to refrain from swimming or hot tub use throughout the study duration
• Subject with significant medical history or current skin diseases that the investigator feels is not safe for study participation;
• Subjects who have been treated with systemic retinoids or steroids within the past month prior to entry to the study;
• Subjects who have been treated with topical steroids, retinoids or other topical drugs within 2 weeks prior to entry to the study;
• Recently treated or current skin diseases that would affect clinical evaluation;
• Subjects who self-report that they are pregnant or nursing;
• Patients with history of investigational drug use in the 30 days prior to entry into the study.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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54 participants in 2 patient groups

regimen group

Experimental group

Description:

After 1 week washout period using provided Dove® Soap without any moisturizer, participants in the skin care regimen group will receive Vaseline® Moisturizer, Dove® Soap, and application log. These participants will be asked to apply the Vaseline® Moisturizer twice a day and use Dove® Soap daily for 2 weeks. All applications should be reported in the application log by the participants. A demonstration and verbal instructions for how and where to apply the products will be provided to the subjects along with the application log for daily use.

Treatment:

Other: skin care regimen

control group

No Intervention group

Description:

After 1 week washout period using provided Dove® Soap without any moisturizer, Individuals in the control group will continue with the provided Dove® Soap for 2 weeks. All applications should be reported in the application log by the participants. A demonstration and verbal instructions for how and where to apply the products will be provided to the subjects along with the application log for daily use.