NCT03497130

The Role of Skin Care Regimen in Skin Health

Completed NA Results posted Last updated 13 May 2020

What this trial tests

NA trial testing skin care regimen in Itching in 54 participants. Completed in 9 April 2020.

Timeline

10 April 2018

Primary endpoint
9 April 2020

9 April 2020

Quick facts

Lead sponsor	Johns Hopkins University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	54
Start date	10 April 2018
Primary completion	9 April 2020
Estimated completion	9 April 2020
Sites	1 location across United States

Drugs / interventions tested

• skin care regimen

Conditions studied

• Itching — all drugs for Itching →
• Xerosis — all drugs for Xerosis →

Sponsor

Johns Hopkins University

Who can join

18 and older, any sex, with Itching or Xerosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Group	Value	95% CI
Regimen Group	-4	-7 – -2
Control Group	-2	-4 – -1

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

Group	Value	95% CI
Regimen Group	-4	-7 – -2
Control Group	-3	-4 – -1

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

symptom

Group	Value	95% CI
Regimen Group	-3	-4 – -1
Control Group	0	-2 – 2

function

Group	Value	95% CI
Regimen Group	-1	-3 – 0
Control Group	0	-2 – 2.5

emotion

Group	Value	95% CI
Regimen Group	-1	-4 – 0
Control Group	0	-1.5 – 1.5

overall

Group	Value	95% CI
Regimen Group	-4	-6 – -1
Control Group	0	-5.5 – 2

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A consistent skin care regimen leads to objective and subjective improvements in dry human skin: investigator-blinded randomized clinical trial.
   Kim S, Ly BK, Ha JH, Carson KA, et al · · 2022 · cited 12× · PMID 32239984 · DOI 10.1080/09546634.2020.1751037