Clinical trial NCT03497130: The Role of Skin Care Regimen in Skin Health
Official title: The Role of Skin Care Regimen in Skin Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Itching
Xerosis
Keywords: skin regimen
moisturizer
dry skin
dry
itchy skin
skin care
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2018-04-13
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Total Clinical Score (TCS) Between the Final Visit and Baseline
timeFrame: Baseline and 3 weeks
measure: Change in Visual Dryness 5-point Severity Score for Total Body Score Between the Final Visit and the Baseline
timeFrame: Baseline and 3 weeks
Secondary outcomes:
measure: Change in Frequency of Itchy-specific Quality-of-life (ItchyQoL) Score Between the Final Visit and Baseline
timeFrame: Baseline and 3 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Cutaneous Translational Research Program
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Anna Chien, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kawada C, Yoshida T, Yoshida H, Matsuoka R, Sakamoto W, Odanaka W, Sato T, Yamasaki T, Kanemitsu T, Masuda Y, Urushibata O. Ingested hyaluronan moisturizes dry skin. Nutr J. 2014 Jul 11;13:70. doi: 10.1186/1475-2891-13-70.
citation: Feng L, Chandar P, Lu N, Vincent C, Bajor J, McGuiness H. Characteristic differences in barrier and hygroscopic properties between normal and cosmetic dry skin. II. Depth profile of natural moisturizing factor and cohesivity. Int J Cosmet Sci. 2014 Jun;36(3):231-8. doi: 10.1111/ics.12118. Epub 2014 Mar 29.
citation: Rawlings AV, Harding CR. Moisturization and skin barrier function. Dermatol Ther. 2004;17 Suppl 1:43-8. doi: 10.1111/j.1396-0296.2004.04s1005.x.