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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03497130
Other study ID # IRB00165140
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 10, 2018
Est. completion date April 9, 2020

Study information

Verified date May 2020
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Cutaneous Translational Research Program Baltimore Maryland

Sponsors (1)

Lead Sponsor Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. Review. — View Citation

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

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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. Baseline and 3 weeks
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