Moisture-associated DermatitisNCT01724229
Clinical Case Series Evaluating Skin Wellness System
A study of Moisture-associated Dermatitis and Fungal Infection in Perineal Area, run by GM Associates at 2 sites in United States.
Trial summary
The purpose of this evaluation is to observe the performance of two (2) different skin care treatment protocols on the skin: #1 Kendall™ Body Wash \& Shampoo in combination with the Moisture Barrier Cream; or #2 Kendall™ 2-in-1 Cleanser in combination with the Anti-fungal Cream. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moisture-associated Dermatitis, Fungal Infection in Perineal Area
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2012to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult subjects with any of the following indications:
- Erythema, maceration, or broken (denuded) skin from moisture, urinary or fecal incontinence
- Irritated, unbroken skin (perineal area)
- Fungal infection present in the perineal area
Who cannot join
- An existing pressure ulcer of any stage where the product will be applied
- Subjects not expected to survive the two week trial
- Subjects under age 18
- Subjects unable to provide informed consent (or whose designated power of attorney is unable to provide)
- Subjects with known sensitivity to any product preservative or other ingredient.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Deer Meadows Retirement Community
Southampton, Pennsylvania
Villa Maria Care Center
Tucson, Arizona
About this study
Official title: An Open-Label Clinical Case Series to Demonstrate Efficacy of the Kendall Skin Wellness System
The purpose of this evaluation is to observe the performance of two (2) different skin care treatment protocols on the skin:
#1 Kendall™ Body Wash \& Shampoo in combination with the Moisture Barrier Cream; or #2 Kendall™ 2-in-1 Cleanser in combination with the Anti-fungal Cream.
The scientific evidence supports using these types of skin care products to keep the skin healthy in the presence of moisture, urine, stool, or fungal infection. The cleansers are preferred over soap and water and can be applied on all areas of the skin. The Moisture Barrier Cream is formulated especially for skin exposed to moisture, urine, or stool. The Antifungal Cream is utilized for fungal infections associated with athlete's foot, jock itch, and ring worm to relieve itching, soreness, and irritation.
Read the detailed description
The Kendall™ Body Wash \& Shampoo is a no-rinse cleanser that gently removed dirt, urine, and stool while maintaining the natural pH of the skin (although it contains a shampoo component); it can be applied on all areas of the skin. Kendall™ Moisture Barrier Cream performs as a barrier to moisture and irritants when the natural barrier ability of the skin has been compromised.
Kendall™ 2-in-1 Cleanser is a no-rinse cleanser that gently removes dirt, urine, and stool and protects the skin from damage. Kendall™ Antifungal Cream is used on fungal infections to relieve itching and discomfort.
- Being tested
- Kendall Body Wash & Shampoo; Moisture Barrier Cream; 2-in-1 Cleanser; Antifungal Cream
- Keywords
- Incontinence-associated dermatitis, Skin care regimen for moisture-associated conditions, Perineal skin care, Fungal infection in perineal area
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kendall Body Wash & Shampoo; Moisture Barrier Cream; 2-in-1 Cleanser; Antifungal CreamDrug
| Study group | Role | What they receive |
|---|---|---|
| treatment with OTC drug products | Other | * Body Wash \& Shampoo applied directly to the skin or cloth; soiled area gently wiped clean. No rinsing necessary.
* Moisture Barrier Cream: Once area cleansed and dried thoroughly, a thin coat is gently applied to the area of the skin exposed to moisture twice daily for two weeks or as directed by doctor.
* 2-in-1 Cleanser: applied directly to the skin or a cloth and skin gently wiped clean. No rinsing necessary.
* Antifungal Cream: Once reddened area cleansed and dried thoroughly a thin layer is applied over the affected area twice daily for two weeks or as directed by doctor. Receives: Drug: Kendall Body Wash & Shampoo; Moisture Barrier Cream; 2-in-1 Cleanser; Antifungal Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
skin condition following treatment
Results of skin assessment will be documented using the IAD (Incontinence-Associated Dermatitis) Skin Condition Assessment Tool. Individual subscores will be added together to provide a ten-point scale for measurement of skin condition
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Moisture-associated DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- GM Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Glenda J Motta, BSN, MPH, ET, Study director, GM Associates Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01724229
- Sponsor's protocol ID
- COV2012
- Status last verified
- Jun 2013
- First submitted
- 7 Nov 2012
- Last updated
- 25 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gray M, Beeckman D, Bliss DZ, Fader M, Logan S, Junkin J, Selekof J, Doughty D, Kurz P. Incontinence-associated dermatitis: a comprehensive review and update. J Wound Ostomy Continence Nurs. 2012 Jan-Feb;39(1):61-74. doi: 10.1097/WON.0b013e31823fe246.
PubMed 22193141Kennedy K, Leighton B, Lutz J. Cost-effectiveness evaluation of a new alchool-free, film-forming incontinence skin protectant. proceedings from the European Conference on Advances in Wound Management, Amsterdam, Oct. 1996
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Clinical Case Series to Demonstrate Efficacy of the Kendall Skin Wellness System
- ClinicalTrials.gov ID
- NCT01724229
- Acronym / sponsor ID
- COV2012
- Keywords
- Incontinence-associated dermatitis, Skin care regimen for moisture-associated conditions, Perineal skin care, Fungal infection in perineal area
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- GM AssociatesIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 9 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this evaluation is to observe the performance of two (2) different skin care treatment protocols on the skin:
#1 Kendall™ Body Wash \& Shampoo in combination with the Moisture Barrier Cream; or #2 Kendall™ 2-in-1 Cleanser in combination with the Anti-fungal Cream.
The scientific evidence supports using these types of skin care products to keep the skin healthy in the presence of moisture, urine, stool, or fungal infection. The cleansers are preferred over soap and water and can be applied on all areas of the skin. The Moisture Barrier Cream is formulated especially for skin exposed to moisture, urine, or stool. The Antifungal Cream is utilized for fungal infections associated with athlete's foot, jock itch, and ring worm to relieve itching, soreness, and irritation.
Detailed description
The Kendall™ Body Wash \& Shampoo is a no-rinse cleanser that gently removed dirt, urine, and stool while maintaining the natural pH of the skin (although it contains a shampoo component); it can be applied on all areas of the skin. Kendall™ Moisture Barrier Cream performs as a barrier to moisture and irritants when the natural barrier ability of the skin has been compromised.
Kendall™ 2-in-1 Cleanser is a no-rinse cleanser that gently removes dirt, urine, and stool and protects the skin from damage. Kendall™ Antifungal Cream is used on fungal infections to relieve itching and discomfort.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment with OTC drug products | Other | Drug: Kendall Body Wash & Shampoo; Moisture Barrier Cream; 2-in-1 Cleanser; Antifungal Cream* Body Wash \& Shampoo applied directly to the skin or cloth; soiled area gently wiped clean. No rinsing necessary. * Moisture Barrier Cream: Once area cleansed and dried thoroughly, a thin coat is gently applied to the area of the skin exposed to moisture twice daily for two weeks or as directed by doctor. * 2-in-1 Cleanser: applied directly to the skin or a cloth and skin gently wiped clean. No rinsing necessary. * Antifungal Cream: Once reddened area cleansed and dried thoroughly a thin layer is applied over the affected area twice daily for two weeks or as directed by doctor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Erythema, maceration, or broken (denuded) skin from moisture, urinary or fecal incontinence
- Irritated, unbroken skin (perineal area)
- Fungal infection present in the perineal area
Key exclusion criteria (5 listed)
- An existing pressure ulcer of any stage where the product will be applied
- Subjects not expected to survive the two week trial
- Subjects under age 18
- Subjects unable to provide informed consent (or whose designated power of attorney is unable to provide)
- Subjects with known sensitivity to any product preservative or other ingredient.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kendall Body Wash & Shampoo; Moisture Barrier Cream; 2-in-1 Cleanser; Antifungal Cream | Drug | treatment with OTC drug products |
Primary outcome
skin condition following treatment
Time frame: 14 days
Results of skin assessment will be documented using the IAD (Incontinence-Associated Dermatitis) Skin Condition Assessment Tool. Individual subscores will be added together to provide a ten-point scale for measurement of skin condition
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2013.
- Background: PubMed 22193141Gray M, Beeckman D, Bliss DZ, Fader M, Logan S, Junkin J, Selekof J, Doughty D, Kurz P. Incontinence-associated dermatitis: a comprehensive review and update. J Wound Ostomy Continence Nurs. 2012 Jan-Feb;39(1):61-74. doi: 10.1097/WON.0b013e31823fe246.
- BackgroundKennedy K, Leighton B, Lutz J. Cost-effectiveness evaluation of a new alchool-free, film-forming incontinence skin protectant. proceedings from the European Conference on Advances in Wound Management, Amsterdam, Oct. 1996
Related trials for Moisture-associated Dermatitis
Enrolling by invitation
Effect of a Standardized Moisture-Care Protocol Using Skin Barrier Spray on Prevention of Pressure Injuries in the Perineal-Sacral Area Among Incontinent Inpatients: A 3-month Pilot Study.
Pressure Injury, Pressure Injury Prevention
Not yet recruiting
Testing the Safety and Efficacy of a Novel Barrier Cream for the Treatment of Moisture Associated Skin Damage
Moisture Associated Skin Damage, Incontinence Associated Dermatitis
Not yet recruiting
Testing a Novel Barrier Cream for Fecal Incontinence in an Ambulatory Population
Moisture Associated Skin Damage, Fecal Incontinence
Enrolling by invitation
Effectiveness of 3M Cavilon Advanced Skin Protectant in the Treatment of Moisture-associated Skin Damage in Hospitals
Irritant Dermatitis, Stoma Site Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glenda J Motta, BSN, MPH, ET study director
GM Associates Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Moisture-associated Dermatitis and Fungal Infection in Perineal Area, run by GM Associates at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
skin condition following treatment (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01724229, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2013.