Skin Protectant Textile for Moisture-Associated Skin Damage

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medline Industries

Must not be taking: Antibiotics, Antifungals, Ointments, others

Disqualifiers: Allergy to SPT, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 5 days

47 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will evaluate the efficacy of the DriGo skin protectant textile (SPT) to manage erythema, maceration, denudation, satellite lesions, pain, itching, burning, moisture, and odor associated with skin folds (henceforth together referred to as "skin fold conditions"). Participants will be patients with skin fold conditions, which will be treated with the SPT. Healthcare providers will apply the SPT to the participants' target areas. A given participant can have up to two target areas enrolled in the study. An independent licensed clinician with experience in identifying and treating skin fold conditions, will use photographs of the skin folds and other skin-on-skin contact areas (henceforth referred to as "target area\[s\]") to assess the status of erythema, maceration, denudation, and satellite lesions in the target areas when the SPT is first applied (Day 0), and on Days 1, 3, and 5, during SPT changes. The Principal Investigator (PI) or qualified designee will take photographs of the target areas and assess moisture and odor in these areas. Participants will provide their impressions of pain, itching and burning in the target area(s) on the same days as the skin fold condition photography. In addition, the study will include feedback from the Health Care Providers (HCPs) about the SPT and overall experience of the participants with the SPT.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if your skin conditions are being treated with certain topical treatments like antibiotics or antifungals.

What data supports the effectiveness of the treatment DriGo Skin Protectant Textile for moisture-associated skin damage?

Research on similar treatments, like a breathable protective ointment and a skin-protection powder, shows they can protect the skin from moisture damage and irritants while maintaining skin hydration. Additionally, a study on a special fabric for atopic dermatitis found it improved skin condition and comfort, suggesting that textiles can be effective in managing skin issues. ^{1 2 3 4 5}

Is the Skin Protectant Textile safe for human use?

The safety of skin protectants, including those similar to DriGo Skin Protectant Textile, has been evaluated in studies with healthy volunteers. These studies generally show that such products are safe and effective in protecting the skin from irritants and moisture without causing harm. ^{1 6 7 8 9}

What makes the DriGo Skin Protectant Textile treatment unique for moisture-associated skin damage?

The DriGo Skin Protectant Textile is unique because it uses a special fabric design with hydrophobic and superhydrophilic layers that can effectively transport moisture away from the skin, keeping it dry and maintaining a warmer body temperature compared to traditional fabrics like cotton. ^{10 11 12 13 14}

Eligibility Criteria

This trial is for adults over 18 with skin fold conditions like redness, moisture damage, and lesions. They must be able to have their condition assessed for up to six days. People with allergies to the SPT's ingredients or those using certain topical treatments can't participate.

Inclusion Criteria

You have skin conditions such as redness, moisture, odor, or discomfort in certain areas.

People whose skin can be checked for up to six days as part of their treatment plan.

Exclusion Criteria

You are allergic to the materials used in the skin prick test or the tape used to secure it.

You are using topical treatments like antibiotics, antifungals, or ointments in the area being studied.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive the DriGo skin protectant textile (SPT) applied to their skin fold conditions. Assessments are conducted on Day 0, and on Days 1, 3, and 5.

5 days

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

Treatment Details

Interventions

• DriGo Skin Protectant Textile

Trial Overview The study tests DriGo Skin Protectant Textile on managing symptoms associated with skin folds such as erythema, lesions, and discomfort. Healthcare providers apply it and monitor changes over five days through photographs and patient feedback.

Participant Groups

Group I: DriGo SPT Experimental Treatment 1 Intervention

All participants will have the DriGo skin protectant textile applied to their skin fold condition.

Who Is Running the Clinical Trial?

Medline Industries

Lead Sponsor

Trials

46

Recruited

23,000+

References

1. Japan pubmed.ncbi.nlm.nih.gov

[Development of a Breathable Protective Ointment for Moisture-associated Skin Damage]. [2020]

2. England pubmed.ncbi.nlm.nih.gov

A pilot study of silver-loaded cellulose fabric with incorporated seaweed for the treatment of atopic dermatitis. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Efficacy of a skin-protection powder for use as a dressing for intractable ulcers. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Management of Moisture-Associated Skin Damage: A Scoping Review. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Moisture-associated skin damage: use of a skin protectant containing manuka honey. [2019]

6. France pubmed.ncbi.nlm.nih.gov

[Invasive and non-invasive studies of the protective action of a silicon-containing cream and its excipient in skin irritation induced by sodium laurylsulfate]. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

A controlled, three-part trial to investigate the barrier function and skin hydration properties of six skin protectants. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

Durability of an Advanced Skin Protectant Compared With Other Commercially Available Products in Healthy Human Volunteers. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Evaluation of moisture penetration through skin protectant barriers by paper chromatography. [2007]

10. England pubmed.ncbi.nlm.nih.gov

Radiative cooling and anisotropic wettability in E-textile for comfortable biofluid monitoring. [2023]

11. Germany pubmed.ncbi.nlm.nih.gov

Bioinspired Janus Textile with Conical Micropores for Human Body Moisture and Thermal Management. [2020]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Flammability and Thermoregulation Properties of Knitted Fabrics as a Potential Candidate for Protective Undergarments. [2022]

13. Bulgaria pubmed.ncbi.nlm.nih.gov

[Hygienic study and evaluation of textile materials with reduced combustibility with reference to the use of the new anti-inflammable preparations Pyrofix 2 and Torflam]. [2006]

14. United States pubmed.ncbi.nlm.nih.gov

The effects of pajama fabrics' water absorption properties on the stratum corneum under mildly cold conditions. [2013]