NCT05824351 is a NA clinical trial of Tanzanian beeswax-pine resin in Abdominal Site, sponsored by Duke University.

Who is sponsoring NCT05824351?

NCT05824351 is sponsored by Duke University.

What drugs are being tested in NCT05824351?

Interventions in NCT05824351: Tanzanian beeswax-pine resin, Domestic beeswax-pine resin, Hollister's AdaptTM Barrier Rings.

What condition does NCT05824351 study?

NCT05824351 studies Abdominal Site, Colostomy Site.

Is NCT05824351 still recruiting?

NCT05824351 is currently completed. Last updated 26 September 2024.

Are results published for NCT05824351?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-09-26 · How we verify

NCT05824351

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

LowCostomy: Dedicated Toward Creating a High-quality, Low-cost Colostomy Appliance for Those in Sub-Saharan Africa

Completed NA Results posted Last updated 26 September 2024

What this trial tests

NA trial testing Tanzanian beeswax-pine resin in Abdominal Site in 50 participants. Completed in 23 June 2023.

Timeline

10 June 2023

Primary endpoint
23 June 2023

23 June 2023

Quick facts

Lead sponsor	Duke University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	50
Start date	10 June 2023
Primary completion	23 June 2023
Estimated completion	23 June 2023
Sites	1 location across United States

Drugs / interventions tested

Tanzanian beeswax-pine resin
Domestic beeswax-pine resin
Hollister's AdaptTM Barrier Rings

Conditions studied

Abdominal Site — all drugs for Abdominal Site →
Colostomy Site — all drugs for Colostomy Site →

Sponsor

Duke University

Who can join

18 and older, any sex, with Abdominal Site or Colostomy Site. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Skin Irritation as Measured by Draize Score for Erythema and Edema Primary · Assessed daily up to 7 days, day 7 reported

The Draize score (for each erythema and edema) has a range of 0 to 4, where a higher score indicated greater irritation. Individual scores below 3 were classified as not severe.

Edema

Group	Value	95% CI
Tanzanian Beeswax-pine Adhesive	0.86	± 0.28
Domestic Beeswax-pine Adhesive	0.03	± 0.17
Control	0	± 0

Erythema

Group	Value	95% CI
Tanzanian Beeswax-pine Adhesive	0.38	± 0.65
Domestic Beeswax-pine Adhesive	0.15	± 0.50
Control	0.44	± 0.66

Skin Irritation as Measured by Survey: "During the Last Week, How Many Hours a Day Have You Been Itching?" Primary · Assessed daily up to 7 days, day 7 reported

Group	Value	95% CI
Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control	40
Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control	2

Skin Irritation as Measured by Survey: "Please Rate the Intensity of Your Itching Over the Past Two Weeks" Primary · Assessed daily up to 14 days, day 14 reported

Group	Value	95% CI
Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control	17
Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control	20
Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control	5

Skin Irritation as Measured by Survey: "Over the Past Week, Has Your Itching Progressively Gotten Better or Worse?" Primary · Assessed daily up to 7 days, day 7 reported

Group	Value	95% CI
Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control	7
Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control	10
Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control	4
Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control	2

Skin Irritation as Measured by Survey: "Rate the Impact of Your Itching (if Any) on SLEEP Over the Last Week" Primary · Assessed daily up to 7 days, day 7 reported

Group	Value	95% CI
Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control	37
Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control	5

Skin Irritation as Measured by Survey: "Rate the Impact of Your Itching (if Any) on LEISURE/SOCIAL ACTIVITIES Over the Last Week" Primary · Assessed daily up to 7 days, day 7 reported

Group	Value	95% CI
Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control	23
Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control	1
Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control	2
Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control	16

Skin Irritation as Measured by Survey: "Rate the Impact of Your Itching (if Any) on HOUSEWORK/ERRANDS Over the Last Week" Primary · Assessed daily up to 7 days, day 7 reported

Group	Value	95% CI
Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control	24
Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control	2
Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control	0
Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control	16

Skin Irritation as Measured by Survey: "Rate the Impact of Your Itching (if Any) on WORK/SCHOOL Over the Last Week" Primary · Assessed daily up to 7 days, day 7 reported

Group	Value	95% CI
Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control	24
Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control	2
Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control	0
Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control	16

Skin Irritation as Measured by Survey: "Mark Whether the Itching (if Any) Spread to the Following Parts of Your Body" Primary · Assessed daily up to 7 days, day 7 reported

Group	Value	95% CI
Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control	2
Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control	1
Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control	39

Number of Participants With Adverse Side Effects Such as Redness, Rash, Skin Irritation, and Infection Secondary · Assessed daily up to 7 days, day 7 reported

Group	Value	95% CI
Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control	6

Overall Well-being as Measured by Daily Survey Secondary · Daily, days 1-7

Number of participants who responded "yes" to the question, "Have you had any major discomfort/irritation/redness/swelling caused any of the three samples?"

Day 1

Group	Value	95% CI
Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control	0

Day 2

Group	Value	95% CI
Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control	0

Day 3

Group	Value	95% CI
Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control	0

Day 4

Group	Value	95% CI
Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control	0

Day 5

Group	Value	95% CI
Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control	1

Day 6

Group	Value	95% CI
Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control	0

Day 7

Group	Value	95% CI
Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control	2

Overall Well-being as Measured by Daily Survey Secondary · Daily, days 1-6

Number of participants who responded "yes" to the question, "Were you able to successfully remove and reattach all three samples + Tegaderm (the clear adhesive) today?"

Day 1

Group	Value	95% CI
Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control	44

Day 2

Group	Value	95% CI
Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control	44

Day 3

Group	Value	95% CI
Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control	43

Day 4

Group	Value	95% CI
Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control	42

Day 5

Group	Value	95% CI
Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control	42

Day 6

Group	Value	95% CI
Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control	44

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 7 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control

Serious: 0/50 (0%)

Deaths: 0/50

Other adverse events (1 terms — click to expand)

Reaction	System	Tanzanian Beeswax-pine Adh…
Skin redness/irritation	Skin and subcutaneous tissue disorders	—

Data from ClinicalTrials.gov NCT05824351 adverse events section.

Sponsor's own description

The purpose of this study is to examine the safety of the LowCostomy appliance's peristomal adhesive interface composed of a mix of beeswax and pine resin.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05824351 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Duke University
Last refreshed: 26 September 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05824351.

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