An interventional study of Mild, moisturizing hand cleanser in Hand Dermatosis, sponsored by Wake Forest University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-09-10.
Sponsored by Wake Forest University · Not applicable, Interventional, and Treatment
The purpose of this study is to find out if the use of a hand cleanser that adds moisture to the skin will help improve skin rashes caused by frequent hand washing (hand dermatitis).
The objective of this protocol is to evaluate compatibility and potential benefits of daily use of a marketed mild, moisturizing hand cleanser for subjects/patients who experience mild to moderate hand dermatitis induced by frequent cleansing.
1,435 studies on the registry are indexed under Dermatitis; 131 are open to participants now.
This study's enrollment of 46 is below the median of 64 across 1,131 interventional studies indexed under Dermatitis.
Browse Dermatitis studies →Wake Forest University is the lead sponsor of 116 studies on the registry; 7 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 27 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The test group will be provided with a mild moisturizing hand cleanser for all hand cleansing needs during the duration of the study.
Other: Mild, moisturizing hand cleanser
The control group will continue to use their current cleanser for all hand washing.
Hand cleanser ingredient list: Ammonium Lauryl Sulfate, Ammonium Laureth Sulfate, Cocamide MEA, PEG-5 Cocamide Cocamidopropyl Betaine Sodium Lauroyl Sarcosinate Glycerin Petrolatum Soybean Oil Sodium Hydroxypropyl Starch Phosphate Lauric Acid Lauryl Alcohol PEG-14M Guar hydroxypropyl trimonium chloride DMDM Hydantoin; Iodopropynyl Butylcarbamate Etidronic Acid Tetrasodium EDTA Titanium Dioxide Fragrance Sodium Hydroxide Water
Investigator Global Assessment
Changes in global disease severity on a scale from 0-4 with 0 being clear and 4 being severe
Time frame: Wk 4
Recruitment was from May 22,2007 to May 12, 2008 at Wake Forest University in Winston Salem.
| Milestone | Test Product | Control Group (Current Product) |
|---|---|---|
| Started | 24 | 18 |
| Completed | 24 | 18 |
| Not completed | 0 | 0 |
Changes in global disease severity on a scale from 0-4 with 0 being clear and 4 being severe
| units on a scale | Mild Moisturizing Hand Cleanser Test Product | No Treatment |
|---|---|---|
| Investigator Global Assessment | 1.0 (0.8 to 1.2) | 1.1 (0.7 to 1.4) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Test Product | — | 0/24 (0%) | 0/24 (0%) |
| Control Group (Current Product) | — | 0/18 (0%) | 0/18 (0%) |
| Age, Categorical(Participants) | Test Product | Control Group (Current Product) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 24 | 18 | 42 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Test Product | Control Group (Current Product) | Total |
|---|---|---|---|
| Median | 45 (18 to 78) | 40 (20 to 65) | 41 (18 to 78) |
| Sex: Female, Male(Participants) | Test Product | Control Group (Current Product) | Total |
|---|---|---|---|
| Female | 20 | 14 | 34 |
| Male | 4 | 4 | 8 |
| Region of Enrollment(participants) | Test Product | Control Group (Current Product) | Total |
|---|---|---|---|
| United States | 24 | 18 | 42 |
Plan to share: No
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This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Wake Forest University