The Role of Skin Care Regimen in Skin Health

NCT03497130 | Completed Results

• 1 other identifier: IRB00165140
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Itching; Xerosis

Keywords

skin regimen; moisturizer; dry skin; dry; itchy skin; skin care

Outcome Measures

Primary Outcomes (2)

• Change in Total Clinical Score (TCS) Between the Final Visit and Baseline

  Evaluated by blinded investigator, consists of three section; erythema (0=no erythema; 4=fiery red with oedema), scaling(0=no scaling; 3=severe scaling), and fissures scored 0-3 (0=no fissure; 3=wide cracks with hemorrhage) yield total between 0 and 10. The evaluation will be done for four sites: both lower legs and both forearms.Total Body Score (TCS) is the sum of three symptoms, i.e., erythema (0 = no erythema, 1 = slight erythema, 2 = moderate uniform redness, 3 = intense redness, 4 = fiery red with edema), scaling (0 = no scaling, 1 = fine scaling, 2 = moderate scaling, 3 = severe scaling with large flakes), and fissure (0 = no crack/fissure, 1 = fine cracks, 2 = single or multiple broader fissures, 3 = wide cracks with hemorrhage or exudation). Thus, the TCS could range from 0 to 10, with the higher scores representing more severe condition.

  Baseline and 3 weeks

• Change in Visual Dryness 5-point Severity Score for Total Body Score Between the Final Visit and the Baseline

  Visual Dryness Severity (VDS) was evaluated by blinded investigator, scored on a 5-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe, yield total between 0 and 4. The evaluation will be done for four sites: both lower legs and both forearms. Total body score is the sum of the four sites, ranging from 0 to 16 with the higher scores representing more severe dryness.

  Baseline and 3 weeks

Secondary Outcomes (1)

• Change in Frequency of Itchy-specific Quality-of-life (ItchyQoL) Score Between the Final Visit and Baseline

  Baseline and 3 weeks

Study Arms (2)

regimen group

EXPERIMENTAL

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.

Other: skin care regimen

control group

NO INTERVENTION

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.

Interventions

skin care regimen OTHER

These participants will be asked to apply skin care regimen, the Vaseline® Moisturizer twice a day and use Dove® Soap daily for 2 weeks.

regimen group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Cutaneous Translational Research Program

Baltimore, Maryland, 21287, United States

Location

Related Publications (3)

• 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.

  PMID: 25014997 BACKGROUND

• 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.

  PMID: 24517532 BACKGROUND

• 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.

  PMID: 14728698 BACKGROUND

MeSH Terms

Conditions

Pruritus

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Anna Chien
• Organization: Department of Dermatology at Johns Hopkins University

achien3@jhmi.edu

410-502-7546

Study Officials

• Anna Chien, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2018
• First Posted: April 13, 2018
• Study Start: April 10, 2018
• Primary Completion: April 9, 2020
• Study Completion: April 9, 2020
• Last Updated: May 13, 2020
• Results First Posted: May 13, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)