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The Role of Skin Care Regimen in Skin Health

Primary Purpose

Itching, Xerosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
skin care regimen
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Itching focused on measuring skin regimen, moisturizer, dry skin, dry, itchy skin, skin care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Cutaneous Translational Research Program

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

regimen group

control group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Change in Frequency of Itchy-specific Quality-of-life (ItchyQoL) Score Between the Final Visit and Baseline
Self-reported itchy related quality of life questions. Total 22 items and each item is scored as frequency. Frequency items are scored on scale of 1-5 (1 = never, 2 = rarely, 3 = sometimes, 4 = often, 5 = all the time) by four measures : Symptom with score range (6-30), Function with score range (7-35), Emotion with score range(9-45) and Overall with score range(22-110). The higher score represents more severe condition.

Full Information

First Posted
April 6, 2018
Last Updated
May 4, 2020
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT03497130
Brief Title
The Role of Skin Care Regimen in Skin Health
Official Title
The Role of Skin Care Regimen in Skin Health
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
April 10, 2018 (Actual)
Primary Completion Date
April 9, 2020 (Actual)
Study Completion Date
April 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Itching, Xerosis
Keywords
skin regimen, moisturizer, dry skin, dry, itchy skin, skin care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
regimen group
Arm Type
Experimental
Arm 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.
Arm Title
control group
Arm Type
No Intervention
Arm 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.
Intervention Type
Other
Intervention Name(s)
skin care regimen
Intervention Description
These participants will be asked to apply skin care regimen, the Vaseline® Moisturizer twice a day and use Dove® Soap daily for 2 weeks.
Primary Outcome Measure Information:
Title
Change in Total Clinical Score (TCS) Between the Final Visit and Baseline
Description
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.
Time Frame
Baseline and 3 weeks
Title
Change in Visual Dryness 5-point Severity Score for Total Body Score Between the Final Visit and the Baseline
Description
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.
Time Frame
Baseline and 3 weeks
Secondary Outcome Measure Information:
Title
Change in Frequency of Itchy-specific Quality-of-life (ItchyQoL) Score Between the Final Visit and Baseline
Description
Self-reported itchy related quality of life questions. Total 22 items and each item is scored as frequency. Frequency items are scored on scale of 1-5 (1 = never, 2 = rarely, 3 = sometimes, 4 = often, 5 = all the time) by four measures : Symptom with score range (6-30), Function with score range (7-35), Emotion with score range(9-45) and Overall with score range(22-110). The higher score represents more severe condition.
Time Frame
Baseline and 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Chien, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cutaneous Translational Research Program
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25014997
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.
Results Reference
background
PubMed Identifier
24517532
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.
Results Reference
background
PubMed Identifier
14728698
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.
Results Reference
background

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The Role of Skin Care Regimen in Skin Health

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