Trial Outcomes & Findings for Skin Protectant Textile Efficacy Study for Managing Skin Fold Conditions (NCT NCT05742347)
NCT ID: NCT05742347
Last Updated: 2025-05-21
Results Overview
The efficacy of the SPT to improve skinfold condition of erythema over three days of treatment were assessed by third party clinicians using a 5-point Likert scales, with "0" being least severe and "4" being most severe. Data is reported as the mean and standard deviation on the scale for each timepoint.
TERMINATED
NA
47 participants
day 0, day 1, day 3
2025-05-21
Participant Flow
Enrollment was based on the total number of target areas for review. A minimum of 80 target areas were required to complete the enrollment.
Unit of analysis: target areas
Participant milestones
| Measure |
DriGo SPT
All participants will have the DriGo skin protectant textile applied to their skin fold condition.
DriGo Skin Protectant Textile: All participants in this study will have the DriGo skin protectant textile applied to their skin fold condition. Erythema, denudation, maceration, odor, and moisture will be assessed following application of the SPT.
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|---|---|
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Overall Study
STARTED
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47 83
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Overall Study
COMPLETED
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46 82
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Overall Study
NOT COMPLETED
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1 1
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
DriGo SPT
n=46 Participants
All participants will have the DriGo skin protectant textile applied to their skin fold condition.
DriGo Skin Protectant Textile: All participants in this study will have the DriGo skin protectant textile applied to their skin fold condition. Erythema, denudation, maceration, odor, and moisture will be assessed following application of the SPT.
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Age, Continuous
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67.61 years
STANDARD_DEVIATION 10.90 • n=46 Participants
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Sex: Female, Male
Female
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37 Participants
n=46 Participants
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Sex: Female, Male
Male
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9 Participants
n=46 Participants
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Region of Enrollment
United States
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46 Participants
n=46 Participants
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PRIMARY outcome
Timeframe: day 0, day 1, day 3Population: Individuals ≥ 18 years of age. who have evidence of one or more of the following skin fold conditions: erythema, maceration, denudation, satellite lesions, pain, itching, burning, moisture, and odor
The efficacy of the SPT to improve skinfold condition of erythema over three days of treatment were assessed by third party clinicians using a 5-point Likert scales, with "0" being least severe and "4" being most severe. Data is reported as the mean and standard deviation on the scale for each timepoint.
Outcome measures
| Measure |
DriGo SPT
n=46 Participants
All participants will have the DriGo skin protectant textile applied to their skin fold condition.
DriGo Skin Protectant Textile: All participants in this study will have the DriGo skin protectant textile applied to their skin fold condition. Erythema, denudation, maceration, odor, and moisture will be assessed following application of the SPT.
|
Summary Statistics of HCP
Summary Statistics of HCP: SPT helped alleviate the skin fold conditions of my patient.
|
Summary Statistics of HCP Was Easy to Apply
Summary Statistics of: SPT was easy to apply - VAS score 0-100 mm
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Summary Statistics of: I Would Recommend DriGo to Others.
Summary Statistics of: I would recommend DriGo to others. Using VAS score 0-100 mm
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|---|---|---|---|---|
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Erythema
Day 0
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2.15 units on a scale
Standard Deviation .82
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—
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—
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—
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Erythema
Day 1
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2.15 units on a scale
Standard Deviation 0.72
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—
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—
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—
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Erythema
Day 3
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.78 units on a scale
Standard Deviation .81
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—
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—
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—
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PRIMARY outcome
Timeframe: day 0, day 1, day 3.Population: Individuals ≥ 18 years of age. who have evidence of one or more of the following skin fold conditions: erythema, maceration, denudation, satellite lesions, pain, itching, burning, moisture, and odor
The efficacy of the SPT to improve skinfold conditions of maceration over three days of treatment were assessed by third party clinician using a 5-point Likert scales, with "0" being least severe and "4" being most severe. Data is reported as the mean and standard deviation values from the scale for each timepoint measured.
Outcome measures
| Measure |
DriGo SPT
n=46 Participants
All participants will have the DriGo skin protectant textile applied to their skin fold condition.
DriGo Skin Protectant Textile: All participants in this study will have the DriGo skin protectant textile applied to their skin fold condition. Erythema, denudation, maceration, odor, and moisture will be assessed following application of the SPT.
|
Summary Statistics of HCP
Summary Statistics of HCP: SPT helped alleviate the skin fold conditions of my patient.
|
Summary Statistics of HCP Was Easy to Apply
Summary Statistics of: SPT was easy to apply - VAS score 0-100 mm
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Summary Statistics of: I Would Recommend DriGo to Others.
Summary Statistics of: I would recommend DriGo to others. Using VAS score 0-100 mm
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|---|---|---|---|---|
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Maceration
Day 0
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0.73 units on a scale
Standard Deviation 0.82
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—
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—
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—
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Maceration
Day 1
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0.49 units on a scale
Standard Deviation 0.65
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—
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—
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—
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Maceration
Day 3
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0.45 units on a scale
Standard Deviation 0.64
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—
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—
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—
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PRIMARY outcome
Timeframe: day 0, day 1, and day 3.Population: Individuals ≥ 18 years of age. who have evidence of one or more of the following skin fold conditions: erythema, maceration, denudation, satellite lesions, pain, itching, burning, moisture, and odor
The efficacy of the SPT to improve skinfold conditions denudation were assessed over 3 days by a third party clinician using a 5-point Likert scales, with "0" being least severe and "4" being most severe. Data is reported as the mean and standard deviation value on the scale for each timepoint measured.
Outcome measures
| Measure |
DriGo SPT
n=46 Participants
All participants will have the DriGo skin protectant textile applied to their skin fold condition.
DriGo Skin Protectant Textile: All participants in this study will have the DriGo skin protectant textile applied to their skin fold condition. Erythema, denudation, maceration, odor, and moisture will be assessed following application of the SPT.
|
Summary Statistics of HCP
Summary Statistics of HCP: SPT helped alleviate the skin fold conditions of my patient.
|
Summary Statistics of HCP Was Easy to Apply
Summary Statistics of: SPT was easy to apply - VAS score 0-100 mm
|
Summary Statistics of: I Would Recommend DriGo to Others.
Summary Statistics of: I would recommend DriGo to others. Using VAS score 0-100 mm
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|---|---|---|---|---|
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Denudation
Day 0
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0.88 units on a scale
Standard Deviation 0.84
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—
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—
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—
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Denudation
Day 1
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0.60 units on a scale
Standard Deviation 0.66
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—
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—
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—
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Denudation
Day 3
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0.20 units on a scale
Standard Deviation 0.44
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—
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—
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—
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PRIMARY outcome
Timeframe: 5 daysPopulation: Individuals ≥ 18 years of age. who have evidence of one or more of the following skin fold conditions: erythema, maceration, denudation, satellite lesions, pain, itching, burning, moisture, and odor
The efficacy of the SPT to improve skinfold conditions of satellite lesions were assessed by a third party clinician as absent or present each day over 5 days. Results for present lesions detected presented below. Data is reported as the percentage of participants identified with any satellite lesions.
Outcome measures
| Measure |
DriGo SPT
n=46 Participants
All participants will have the DriGo skin protectant textile applied to their skin fold condition.
DriGo Skin Protectant Textile: All participants in this study will have the DriGo skin protectant textile applied to their skin fold condition. Erythema, denudation, maceration, odor, and moisture will be assessed following application of the SPT.
|
Summary Statistics of HCP
Summary Statistics of HCP: SPT helped alleviate the skin fold conditions of my patient.
|
Summary Statistics of HCP Was Easy to Apply
Summary Statistics of: SPT was easy to apply - VAS score 0-100 mm
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Summary Statistics of: I Would Recommend DriGo to Others.
Summary Statistics of: I would recommend DriGo to others. Using VAS score 0-100 mm
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|---|---|---|---|---|
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Satellite Lesions
day 0
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5 participants
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—
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—
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—
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Satellite Lesions
day 1
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5 participants
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—
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—
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—
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Satellite Lesions
day 3
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3 participants
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—
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—
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—
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Satellite Lesions
day 5
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0 participants
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—
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—
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—
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PRIMARY outcome
Timeframe: Day 0, day 1, day 3 and day 5Population: Individuals ≥ 18 years of age. who have evidence of one or more of the following skin fold conditions: erythema, maceration, denudation, satellite lesions, pain, itching, burning, moisture, and odor
The efficacy of the SPT to improve skinfold conditions of odor over five days of treatment was assessed by a third party clinician as absent or present with values for present noted below. Data is presented as the percentage of participants identified with any odor at the target area for each timepoint measured.
Outcome measures
| Measure |
DriGo SPT
n=46 Participants
All participants will have the DriGo skin protectant textile applied to their skin fold condition.
DriGo Skin Protectant Textile: All participants in this study will have the DriGo skin protectant textile applied to their skin fold condition. Erythema, denudation, maceration, odor, and moisture will be assessed following application of the SPT.
|
Summary Statistics of HCP
Summary Statistics of HCP: SPT helped alleviate the skin fold conditions of my patient.
|
Summary Statistics of HCP Was Easy to Apply
Summary Statistics of: SPT was easy to apply - VAS score 0-100 mm
|
Summary Statistics of: I Would Recommend DriGo to Others.
Summary Statistics of: I would recommend DriGo to others. Using VAS score 0-100 mm
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|---|---|---|---|---|
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Odor
Odor Present day 0
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23 participants
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—
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—
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—
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Odor
Odor present day 1
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11 participants
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—
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—
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—
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Odor
Odor present day 3
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12 participants
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—
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—
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—
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Odor
odor present day 5
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10 participants
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—
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—
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—
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SECONDARY outcome
Timeframe: Day 0, day 1, day 3, and day 5Population: Individuals ≥ 18 years of age. who have evidence of one or more of the following skin fold conditions: erythema, maceration, denudation, satellite lesions, pain, itching, burning, moisture, and odor
survey responses for moisture in the target area(s) on Day 0, and on Days 1, 3, and 5, during SPT changes, third party clinicians assessed the moisture as either abscent/scant or small/moderate. All other patients were coded as not able to detect. Data is presented as the percentage of participants with abscent/scant moisture at each timepoint and the percentage of participants with small/moderate moisture at each timepoint.
Outcome measures
| Measure |
DriGo SPT
n=46 Participants
All participants will have the DriGo skin protectant textile applied to their skin fold condition.
DriGo Skin Protectant Textile: All participants in this study will have the DriGo skin protectant textile applied to their skin fold condition. Erythema, denudation, maceration, odor, and moisture will be assessed following application of the SPT.
|
Summary Statistics of HCP
Summary Statistics of HCP: SPT helped alleviate the skin fold conditions of my patient.
|
Summary Statistics of HCP Was Easy to Apply
Summary Statistics of: SPT was easy to apply - VAS score 0-100 mm
|
Summary Statistics of: I Would Recommend DriGo to Others.
Summary Statistics of: I would recommend DriGo to others. Using VAS score 0-100 mm
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|---|---|---|---|---|
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Survey Responses for Moisture in the Target Area(s) on Assessment of Moisture Control.
Moisture absent/scant day 0
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15 participants
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—
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—
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—
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Survey Responses for Moisture in the Target Area(s) on Assessment of Moisture Control.
Moisture small/moderate day 0
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20 participants
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—
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—
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—
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Survey Responses for Moisture in the Target Area(s) on Assessment of Moisture Control.
Moisture absent/scant day 1
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13 participants
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—
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—
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—
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Survey Responses for Moisture in the Target Area(s) on Assessment of Moisture Control.
Moisture small/moderate day 1
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16 participants
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—
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—
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—
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Survey Responses for Moisture in the Target Area(s) on Assessment of Moisture Control.
Moisture absent/scant day 3
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15 participants
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—
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—
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—
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Survey Responses for Moisture in the Target Area(s) on Assessment of Moisture Control.
Moisture small/moderate day 3
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7 participants
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—
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—
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—
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Survey Responses for Moisture in the Target Area(s) on Assessment of Moisture Control.
Moisture absent/scant day 5
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10 participants
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—
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—
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—
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Survey Responses for Moisture in the Target Area(s) on Assessment of Moisture Control.
Moisture small/moderate day 5
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4 participants
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—
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—
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—
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SECONDARY outcome
Timeframe: day 0, day 1, day 3Population: Individuals ≥ 18 years of age. who have evidence of one or more of the following skin fold conditions: erythema, maceration, denudation, satellite lesions, pain, itching, burning, moisture, and odor
Assessing Patient reported outcomes before the dressing change - VAS score 0-100 mm with 0 being the least amount of pain and 100 being the most painful.
Outcome measures
| Measure |
DriGo SPT
n=46 Participants
All participants will have the DriGo skin protectant textile applied to their skin fold condition.
DriGo Skin Protectant Textile: All participants in this study will have the DriGo skin protectant textile applied to their skin fold condition. Erythema, denudation, maceration, odor, and moisture will be assessed following application of the SPT.
|
Summary Statistics of HCP
Summary Statistics of HCP: SPT helped alleviate the skin fold conditions of my patient.
|
Summary Statistics of HCP Was Easy to Apply
Summary Statistics of: SPT was easy to apply - VAS score 0-100 mm
|
Summary Statistics of: I Would Recommend DriGo to Others.
Summary Statistics of: I would recommend DriGo to others. Using VAS score 0-100 mm
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|---|---|---|---|---|
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Assessing Patient Reported Outcomes of Discomfort (Pain, Itching, Burning) Before Dressing Change
Discomfort (Pain, Itching, or Burning) experienced before the dressing change. Day 0
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17 score on a scale - VAS score 0-100 mm
Standard Deviation 34
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—
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—
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—
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Assessing Patient Reported Outcomes of Discomfort (Pain, Itching, Burning) Before Dressing Change
Discomfort (Pain, Itching, or Burning) experienced before the dressing change. Day 1
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0 score on a scale - VAS score 0-100 mm
Standard Deviation 23
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—
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—
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—
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Assessing Patient Reported Outcomes of Discomfort (Pain, Itching, Burning) Before Dressing Change
Discomfort (Pain, Itching, or Burning) experienced before the dressing change. Day 3
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0 score on a scale - VAS score 0-100 mm
Standard Deviation 22
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—
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—
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—
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SECONDARY outcome
Timeframe: day 0, day 1, day3Population: Individuals ≥ 18 years of age. who have evidence of one or more of the following skin fold conditions: erythema, maceration, denudation, satellite lesions, pain, itching, burning, moisture, and odor
Assessing patient reported outcomes of discomfort (Pain, Itching, or Burning) experienced after the dressing change Patient Reported Outcomes: VAS score 0-100 mm with 0 being the least painful and 100 being the most painful
Outcome measures
| Measure |
DriGo SPT
n=46 Participants
All participants will have the DriGo skin protectant textile applied to their skin fold condition.
DriGo Skin Protectant Textile: All participants in this study will have the DriGo skin protectant textile applied to their skin fold condition. Erythema, denudation, maceration, odor, and moisture will be assessed following application of the SPT.
|
Summary Statistics of HCP
Summary Statistics of HCP: SPT helped alleviate the skin fold conditions of my patient.
|
Summary Statistics of HCP Was Easy to Apply
Summary Statistics of: SPT was easy to apply - VAS score 0-100 mm
|
Summary Statistics of: I Would Recommend DriGo to Others.
Summary Statistics of: I would recommend DriGo to others. Using VAS score 0-100 mm
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|---|---|---|---|---|
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Patient Report of Pain Itching or Burning After Dressing Change Day 0, Day 1, and Day 3
discomfort (Pain, Itching, or Burning) experienced after the dressing change Day 3
|
8.1 score on a scale - VAS score 0-100 mm
Standard Deviation 17
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—
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—
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—
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Patient Report of Pain Itching or Burning After Dressing Change Day 0, Day 1, and Day 3
discomfort (Pain, Itching, or Burning) experienced after the dressing change Day 0
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24.7 score on a scale - VAS score 0-100 mm
Standard Deviation 32
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—
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—
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—
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Patient Report of Pain Itching or Burning After Dressing Change Day 0, Day 1, and Day 3
discomfort (Pain, Itching, or Burning) experienced after the dressing change Day 1
|
10.6 score on a scale - VAS score 0-100 mm
Standard Deviation 18
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—
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—
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—
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SECONDARY outcome
Timeframe: Day 5Population: ndividuals ≥ 18 years of age. who have evidence of one or more of the following skin fold conditions: erythema, maceration, denudation, satellite lesions, pain, itching, burning, moisture, and odor
Summary Statistics of: The dressing significantly reduced discomfort (Pain, Itching, and Burning) in the skin-on-skin contact area (target area) at Day 5 with 0 being not at all and 100 being absolutely yes it helped reduce my discomfort.
Outcome measures
| Measure |
DriGo SPT
n=46 Participants
All participants will have the DriGo skin protectant textile applied to their skin fold condition.
DriGo Skin Protectant Textile: All participants in this study will have the DriGo skin protectant textile applied to their skin fold condition. Erythema, denudation, maceration, odor, and moisture will be assessed following application of the SPT.
|
Summary Statistics of HCP
Summary Statistics of HCP: SPT helped alleviate the skin fold conditions of my patient.
|
Summary Statistics of HCP Was Easy to Apply
Summary Statistics of: SPT was easy to apply - VAS score 0-100 mm
|
Summary Statistics of: I Would Recommend DriGo to Others.
Summary Statistics of: I would recommend DriGo to others. Using VAS score 0-100 mm
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|---|---|---|---|---|
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Did the Product Reduce Your Discomfort Assessed at Discharge Day 5
|
98 score on a scale VAS score 0-100 mm
Standard Deviation 23
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—
|
—
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—
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SECONDARY outcome
Timeframe: Day 5Population: Individuals ≥ 18 years of age. who have evidence of one or more of the following skin fold conditions: erythema, maceration, denudation, satellite lesions, pain, itching, burning, moisture, and odor
Summary Statistics of: The dressing was comfortable to wear at at Day 5. VAS score 0-100 mm with 0 being not at all comfortable and 100 being the most comfortable.
Outcome measures
| Measure |
DriGo SPT
n=46 Participants
All participants will have the DriGo skin protectant textile applied to their skin fold condition.
DriGo Skin Protectant Textile: All participants in this study will have the DriGo skin protectant textile applied to their skin fold condition. Erythema, denudation, maceration, odor, and moisture will be assessed following application of the SPT.
|
Summary Statistics of HCP
Summary Statistics of HCP: SPT helped alleviate the skin fold conditions of my patient.
|
Summary Statistics of HCP Was Easy to Apply
Summary Statistics of: SPT was easy to apply - VAS score 0-100 mm
|
Summary Statistics of: I Would Recommend DriGo to Others.
Summary Statistics of: I would recommend DriGo to others. Using VAS score 0-100 mm
|
|---|---|---|---|---|
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The Product Dressing Was Comfortable to Wear
|
96 score on a scale - VAS score 0-100 mm
Standard Deviation 8.9
|
—
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—
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—
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SECONDARY outcome
Timeframe: End of the study on day 5Population: HCP
Summary Statistics of HCP: Instructions for application of the skin protectant textile (SPT) were easy to understand. Health care practioniers (HCPs) answered a series of questions regarding the instructions for the product. Each question answered on a scale of 0-100 with 0 being negative/difficult/not likely to reccomend and 100 being positive/easy to use/likely to reccomend to others. Data is reported as the mean value for the question asked based on the scale value of 0-100. These questions were only asked of the HCP at the end of the study on day 5.
Outcome measures
| Measure |
DriGo SPT
n=40 Participants
All participants will have the DriGo skin protectant textile applied to their skin fold condition.
DriGo Skin Protectant Textile: All participants in this study will have the DriGo skin protectant textile applied to their skin fold condition. Erythema, denudation, maceration, odor, and moisture will be assessed following application of the SPT.
|
Summary Statistics of HCP
n=40 Participants
Summary Statistics of HCP: SPT helped alleviate the skin fold conditions of my patient.
|
Summary Statistics of HCP Was Easy to Apply
n=40 Participants
Summary Statistics of: SPT was easy to apply - VAS score 0-100 mm
|
Summary Statistics of: I Would Recommend DriGo to Others.
n=40 Participants
Summary Statistics of: I would recommend DriGo to others. Using VAS score 0-100 mm
|
|---|---|---|---|---|
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Summary Statistics of HCP - HCP Reported Ease of Use: VAS Score 0-100 mm
|
93 score on a scale - VAS score 0-100 mm
Standard Deviation 12
|
89 score on a scale - VAS score 0-100 mm
Standard Deviation 20
|
97 score on a scale - VAS score 0-100 mm
Standard Deviation 6.8
|
94 score on a scale - VAS score 0-100 mm
Standard Deviation 18
|
Adverse Events
All Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60