Trial Outcomes & Findings for An Exploratory Study Investigating Human Skin Reaction to Output (NCT NCT02351791)

Results Overview

Trans Epidermal Water Loss is a standardized non-invasive method for describing the barrier function of the skin. Damage to the skin surface (stratum corneum) will lower the barrier of the skin and thereby increase water loss. This can be used as a measure for the damaging effect of the adhesives to the skin. Trans Epidermal Water Loss is measured by applying a probe to the skin surface and is assessed nine times for each patch after applying the patch: three repeated measurements of the skin covered by the center of the patch (Center), as well as three repeated measurements of the skin covered by the adhesive (Under adhesive).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

22 participants

Primary outcome timeframe

Approximately 7-10 hours

Results posted on

2023-10-02

Participant Flow

Participant milestones

Participant milestones
Measure	Peristomal Patches: Patch 1, 3 and 5 Patch 1, Patch 3 and Patch 5 applied on peristomal skin. Patch 1 - Patch 6 applied on healthy abdominal skin Measurements of skin at three locations of each patch: Center and under adhesive. Patch 1: Patch 1:standard adhesive with own feces in sleeve Patch 2: Patch 2:standard adhesive with own feces mixture in sleeve Patch 3: Patch 3: standard adhesive with simulated feces in sleeve Patch 4: Patch 4:standard adhesive with simulated feces mixture in sleeve Patch 5: Patch 5:standard adhesive with buffer in sleeve Patch 6: Patch 6:standard adhesive with buffer mixture in sleeve	Peristomal Patches: Patch 2, 4 and 6 Patch 2, Patch 4 and Patch 6 applied on peristomal skin. Patch 1- Patch 6 applied on healthy abdominal skin Measurements of skin at three locations of each patch: Center and under adhesive. Patch 1: Patch 1:standard adhesive with own feces in sleeve Patch 2: Patch 2:standard adhesive with own feces mixture in sleeve Patch 3: Patch 3: standard adhesive with simulated feces in sleeve Patch 4: Patch 4:standard adhesive with simulated feces mixture in sleeve Patch 5: Patch 5:standard adhesive with buffer in sleeve Patch 6: Patch 6:standard adhesive with buffer mixture in sleeve
Overall Study STARTED	12	10
Overall Study COMPLETED	12	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Exploratory Study Investigating Human Skin Reaction to Output

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Peristomal Patches: Patch 1, 3 and 5 n=12 Participants Patch 1, Patch 3 and Patch 5 applied on peristomal skin. Patch 1 - Patch 6 applied on healthy abdominal skin Measurements of skin at three locations of each patch: Center and under adhesive. Patch 1: Patch 1:standard adhesive with own feces in sleeve Patch 2: Patch 2:standard adhesive with own feces mixture in sleeve Patch 3: Patch 3: standard adhesive with simulated feces in sleeve Patch 4: Patch 4:standard adhesive with simulated feces mixture in sleeve Patch 5: Patch 5:standard adhesive with buffer in sleeve Patch 6: Patch 6:standard adhesive with buffer mixture in sleeve	Peristomal Patches: Patch 2, 4 and 6 n=10 Participants Patch 2, Patch 4 and Patch 6 applied on peristomal skin. Patch 1- Patch 6 applied on healthy abdominal skin Measurements of skin at three locations of each patch: Center and under adhesive. Patch 1: Patch 1:standard adhesive with own feces in sleeve Patch 2: Patch 2:standard adhesive with own feces mixture in sleeve Patch 3: Patch 3: standard adhesive with simulated feces in sleeve Patch 4: Patch 4:standard adhesive with simulated feces mixture in sleeve Patch 5: Patch 5:standard adhesive with buffer in sleeve Patch 6: Patch 6:standard adhesive with buffer mixture in sleeve	Total n=22 Participants Total of all reporting groups
Age, Continuous	63.1 years STANDARD_DEVIATION 12.9 • n=5 Participants	64.1 years STANDARD_DEVIATION 5.2 • n=7 Participants	63.5 years STANDARD_DEVIATION 10.0 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: Approximately 7-10 hours

Population: three repeated measurements per participant were performed and used in analysis e.g. 12 participants have 3x12=36 units analysed.

Trans Epidermal Water Loss is a standardized non-invasive method for describing the barrier function of the skin. Damage to the skin surface (stratum corneum) will lower the barrier of the skin and thereby increase water loss. This can be used as a measure for the damaging effect of the adhesives to the skin. Trans Epidermal Water Loss is measured by applying a probe to the skin surface and is assessed nine times for each patch after applying the patch: three repeated measurements of the skin covered by the center of the patch (Center), as well as three repeated measurements of the skin covered by the adhesive (Under adhesive).

Outcome measures

Outcome measures
Measure	Peristomal Skin Patch 1 Center n=36 3 repeated measurements per participant Measurement on skin (in the center of the patch) exposed to patch 1 (standard adhesive with own feces in sleeve)	Peristomal Skin Patch 2 Center n=30 3 repeated measurements per participant Measurement on skin (in the center of the patch) exposed to patch 2 (standard adhesive with own feces mixture in sleeve)	Peristomal Skin Patch 3 Center n=36 3 repeated measurements per participant Measurement on skin (in the center of the patch) exposed to patch 3 (standard adhesive with simulated feces in sleeve)	Peristomal Skin Patch 4 Center n=30 3 repeated measurements per participant Measurement on skin (in the center of the patch) exposed to patch 4 (standard adhesive with simualted feces mixture in sleeve)	Peristomal Skin Patch 5 Center n=36 3 repeated measurements per participant Measurement on skin (in the center of the patch) exposed to patch 5 (standard adhesive with buffer in sleeve)	Peristomal Skin Patch 6 Center n=30 3 repeated measurements per participant Measurement on skin (in the center of the patch) exposed to patch 6 (standard adhesive with buffer mixture in sleeve)	Abdominal Skin Patch 1 Center n=66 3 repeated measurements per participant Measurement on skin (in the center of the patch) exposed to patch 1 (standard adhesive with own feces in sleeve)	Abdominal Skin Patch 2 Center n=66 3 repeated measurements per participant Measurement on skin (in the center of the patch) exposed to patch 2 (standard adhesive with own feces mixture in sleeve)	Abdominal Skin Patch 3 Center n=66 3 repeated measurements per participant Measurement on skin (in the center of the patch) exposed to patch 3 (standard adhesive with simulated feces in sleeve)	Abdominal Skin Patch 4 Center n=66 3 repeated measurements per participant Measurement on skin (in the center of the patch) exposed to patch 4 (standard adhesive with simulated feces mixture in sleeve)	Abdominal Skin Patch 5 Center n=66 3 repeated measurements per participant Measurement on skin (in the center of the patch) exposed to patch 5 (standard adhesive with buffer in sleeve)	Abdominal Skin Patch 6 Center n=66 3 repeated measurements per participant Measurement on skin (in the center of the patch) exposed to patch 6 (standard adhesive with buffer mixture in sleeve)	Peristomal Skin Patch 1 Under Adhesive n=36 3 repeated measurements per participant Measurement on skin (covered by adhesive after removal of patch) exposed to patch 1 (standard adhesive with own feces in sleeve)	Peristomal Skin Patch 2 Under Adhesive n=30 3 repeated measurements per participant Measurement on skin (covered by adhesive after removal of patch) exposed to patch 2 (standard adhesive with own feces mixture in sleeve)	Peristomal Skin Patch 3 Under Adhesive n=36 3 repeated measurements per participant Measurement on skin (covered by adhesive after removal of patch) exposed to patch 3 (standard adhesive with simulated feces in sleeve)	Peristomal Skin Patch 4 Under Patch n=30 3 repeated measurements per participant Measurement on skin (covered by adhesive after removal of patch) exposed to patch 4(standard adhesive with simulated feces mixture in sleeve)	Peristomal Skin Patch 5 Under Adhesive n=36 3 repeated measurements per participant Measurement on skin (covered by adhesive after removal of patch) exposed to patch 5 (standard adhesive with buffer in sleeve)	Peristomal Skin Patch 6 Under Patch n=30 3 repeated measurements per participant Measurement on skin (covered by adhesive after removal of patch) exposed to patch 6 (standard adhesive with buffer mixture in sleeve)	Abdominal Skin Patch 1 Under Adhesive n=66 3 repeated measurements per participant Measurement on skin (covered by adhesive after removal of patch) exposed to patch 1 (standard adhesive with own feces in sleeve)	Abdominal Skin Patch 2 Under Adhesive n=66 3 repeated measurements per participant Measurement on skin (covered by adhesive after removal of patch) exposed to patch 2 (standard adhesive with own feces mixture in sleeve)	Abdominal Skin Patch 3 Under Adhesive n=66 3 repeated measurements per participant Measurement on skin (covered by adhesive after removal of patch) exposed to patch 3 (standard adhesive with simulated feces in sleeve)	Abdominal Skin Patch 4 Under Adhesive n=66 3 repeated measurements per participant Measurement on skin (covered by adhesive after removal of patch) exposed to patch 4 (standard adhesive with simulated feces mixture in sleeve)	Abdominal Skin Patch 5 Under Adhesive n=66 3 repeated measurements per participant Measurement on skin (covered by adhesive after removal of patch) exposed to patch 5 (standard adhesive with buffer in sleeve)	Abdominal Skin Patch 6 Under Adhesive n=66 3 repeated measurements per participant Measurement on skin (covered by adhesive after removal of patch) exposed to patch 6 (standard adhesive withbuffer mixture in sleeve)
Trans Epidermal Water Loss After Test of Patches.	45.8 g/m^2/h Standard Deviation 29.3	22.9 g/m^2/h Standard Deviation 16.4	36.8 g/m^2/h Standard Deviation 21.7	19.6 g/m^2/h Standard Deviation 11.6	15.7 g/m^2/h Standard Deviation 6.9	13.3 g/m^2/h Standard Deviation 7.1	30.1 g/m^2/h Standard Deviation 25.5	22.7 g/m^2/h Standard Deviation 23.1	31.5 g/m^2/h Standard Deviation 27.7	14.5 g/m^2/h Standard Deviation 12.7	13.2 g/m^2/h Standard Deviation 8.7	12.2 g/m^2/h Standard Deviation 7.6	19.5 g/m^2/h Standard Deviation 16.4	12.3 g/m^2/h Standard Deviation 8.7	14.5 g/m^2/h Standard Deviation 11.7	14.7 g/m^2/h Standard Deviation 7.6	13.8 g/m^2/h Standard Deviation 8.8	15.1 g/m^2/h Standard Deviation 8.1	19.0 g/m^2/h Standard Deviation 12.7	19.9 g/m^2/h Standard Deviation 16.5	18.7 g/m^2/h Standard Deviation 15.4	17.3 g/m^2/h Standard Deviation 15.1	15.3 g/m^2/h Standard Deviation 11.1	15.7 g/m^2/h Standard Deviation 10.4

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	All Participants n=24 participants at risk This population also includes the two subject who were included in the screening period. Both AEs were related to the investigational procedures (one to the biopsy and one to the pre-stripping of the skin). Thus the AEs are not reported for each intervention separately as the AEs were unrelated to intervention.
Infections and infestations infection in biopsies	4.2% 1/24 • Number of events 1 • 17 days Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
Skin and subcutaneous tissue disorders dermatitis	4.2% 1/24 • Number of events 1 • 17 days Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research

Additional Information

Sara Gosk

Scientific and Regulatory affairs

Phone: +45 49113568

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place