Hand Dermatosis
Conditions
Keywords
Hand dermatitis
Brief summary
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).
Detailed description
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.
Interventions
OTHERMild, moisturizing hand cleanser
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
Sponsors
Wake Forest University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Between 18 and 65 years of age * In general good health * Hands free of cuts and abrasions * Agree to adhere to the requirements listed in the informed consent * Willing and able to use a mild, moisturizing, non-antibacterial cleanser for all hand washing purposes for the duration of the test period * Willing to refrain from participating in any other clinical research trial for the duration of the study
Exclusion criteria
* Documented allergies to study product components, soaps, latex, or fragrances * History of the following conditions which may affect the response of the skin or the interpretation of the results: insulin dependent diabetes, or peripheral vascular diseases * Participating in a concurrent clinical study involving treatment of your hands * Currently using a prescription medication for hand dermatitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigator Global Assessment | Wk 4 | Changes in global disease severity on a scale from 0-4 with 0 being clear and 4 being severe |
Countries
United States
Participant flow
Recruitment details
Recruitment was from May 22,2007 to May 12, 2008 at Wake Forest University in Winston Salem.
Participants by arm
| Arm | Count |
|---|---|
| Test Product The test group was provided with a test product for all hand cleansing needs during the duration of the study. | 24 |
| Control Group (Current Product) The control group continued to use their current cleanser for hand washing. | 18 |
| Total | 42 |
Baseline characteristics
| Characteristic | Control Group (Current Product) | Test Product | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 24 Participants | 42 Participants |
| Age, Continuous | 40 years | 45 years | 41 years |
| Region of Enrollment United States | 18 participants | 24 participants | 42 participants |
| Sex: Female, Male Female | 14 Participants | 20 Participants | 34 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 24 | 0 / 18 |
| serious Total, serious adverse events | 0 / 24 | 0 / 18 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Mild Moisturizing Hand Cleanser Test Product | Investigator Global Assessment | 1.0 units on a scale |
| No Treatment | Investigator Global Assessment | 1.1 units on a scale |