The Role of Skin Care Regimen in Skin Health

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03497130
• Collaborator: (none)
• Enrollment: 54
• Location: 1
• Arms: 2
• Actual Duration (Months): 24
• Patients Per Site Per Month: 2.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Itching; Xerosis	Other: skin care regimen	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 54 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: The Role of Skin Care Regimen in Skin Health
• Actual Study Start Date: Apr 10, 2018
• Actual Primary Completion Date: Apr 9, 2020
• Actual Study Completion Date: Apr 9, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: regimen group 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; These participants will be asked to apply skin care regimen, the Vaseline® Moisturizer twice a day and use Dove® Soap daily for 2 weeks.
No Intervention: control group 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.

Outcome Measures

Primary Outcome Measures

1. Change in Total Clinical Score (TCS) Between the Final Visit and Baseline [Baseline and 3 weeks]

   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.

2. Change in Visual Dryness 5-point Severity Score for Total Body Score Between the Final Visit and the Baseline [Baseline and 3 weeks]

   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

1. Change in Frequency of Itchy-specific Quality-of-life (ItchyQoL) Score Between the Final Visit and Baseline [Baseline and 3 weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cutaneous Translational Research Program	Baltimore	Maryland	United States	21287

Sponsors and Collaborators

• Johns Hopkins University

Investigators

• Principal Investigator: Anna Chien, MD, Johns Hopkins University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 5, 2018
• Informed Consent Form - Apr 10, 2018

More Information

Publications

• 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.
• 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. Review.
• Rawlings AV, Harding CR. Moisturization and skin barrier function. Dermatol Ther. 2004;17 Suppl 1:43-8. Review.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT03497130
• Other Study ID Numbers: IRB00165140
• First Posted: Apr 13, 2018
• Last Update Posted: May 13, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Johns Hopkins University: skin regimen; moisturizer; dry skin; dry; itchy skin; skin care
• Additional relevant MeSH terms: Pruritus

Study Results

Participant Flow

Arm/Group Title	Regimen Group	Control Group
Arm/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.	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.
Period Title: Overall Study
STARTED	40	14
COMPLETED	39	13
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Regimen Group	Control Group	Total
Arm/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.	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.	Total of all reporting groups
Overall Participants	40	14	54
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	30	24	28
Sex: Female, Male (Count of Participants)
Female	25 62.5%	10 71.4%	35 64.8%
Male	15 37.5%	4 28.6%	19 35.2%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	40 100%	14 100%	54 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Regimen Group	Control Group
Arm/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.	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.
Measure Participants	39	13
Median (Inter-Quartile Range) [score on a scale]	-4	-2

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Regimen Group	Control Group
Arm/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.	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.
Measure Participants	39	13
Median (Inter-Quartile Range) [score on a scale]	-4	-3

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Regimen Group	Control Group
Arm/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.	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.
Measure Participants	39	13
symptom	-3	0
function	-1	0
emotion	-1	0
overall	-4	0

Adverse Events

Time Frame	Adverse event data were collected within 2 weeks of product application in the study
Arm/Group Title	Regimen Group		Control Group
Arm/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.		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.
All Cause Mortality
	Regimen Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/39 (0%)		0/13 (0%)
Serious Adverse Events
	Regimen Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/39 (0%)		0/13 (0%)
Other (Not Including Serious) Adverse Events
	Regimen Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/39 (0%)		0/13 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.