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Skin Protectant
Skin Protectant Textile for Moisture-Associated Skin Damage
N/A
Waitlist Available
Research Sponsored by Medline Industries
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 days
Awards & highlights
Study Summary
This trial will assess the effectiveness of a skin protectant textile to treat skin fold conditions like erythema, maceration, denudation, and satellite lesions. Participants will be monitored for symptoms like pain, itching, and burning, and their impressions will be recorded. Healthcare providers will also give feedback on the product.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include reactions at the application site due to sensitivity to the textile's materials or any adhesives used.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To evaluate the efficacy of SPT to improve skin fold conditions as it pertains to participant assessment
To evaluate the efficacy of SPT to improve skin fold conditions as it pertains to skin fold healing
Secondary outcome measures
To assess HCP feedback on the SPT
To assess the overall participant experience with the SPT
To gather PI or qualified designee's assessment of moisture control in the target areas
Side effects data
From 2019 Phase 3 trial • 80 Patients • NCT0182971139%
Oedema peripheral
35%
Nausea
33%
Headache
33%
Fatigue
28%
Pyrexia
24%
Hypocalcaemia
24%
Hypophosphataemia
23%
Constipation
21%
Alanine aminotransferase increased
21%
Anaemia
21%
Diarrhoea
20%
Lymphocyte count decreased
20%
Hypoalbuminaemia
19%
Aspartate aminotransferase increased
19%
Chills
18%
Vomiting
16%
Arthralgia
16%
Hypokalaemia
15%
Hypertension
15%
Back pain
15%
Pain in extremity
14%
Decreased appetite
14%
Face oedema
14%
Myalgia
13%
Abdominal distension
13%
Asthenia
11%
Anxiety
11%
Hyponatraemia
11%
Platelet count decreased
10%
Dizziness
10%
Insomnia
10%
Dyspnoea
10%
Blood creatinine increased
10%
Hyperglycaemia
10%
White blood cell count decreased
9%
Paraesthesia
9%
Cough
9%
Vision blurred
9%
Abdominal pain
8%
Haptoglobin decreased
8%
Pruritus
8%
Hypotension
8%
Oropharyngeal pain
8%
Hyperkalaemia
8%
Hypomagnesaemia
8%
Weight increased
8%
Haemolytic uraemic syndrome
8%
Sinus tachycardia
8%
Dry eye
6%
Dysgeusia
6%
Infusion related reaction
6%
Nasal congestion
6%
Pleural effusion
6%
Upper respiratory tract infection
6%
Haematuria
6%
Blood bilirubin increased
6%
Neutrophil count decreased
6%
Flatulence
6%
Musculoskeletal pain
5%
Rash
5%
Rash maculo-papular
5%
Capillary leak syndrome
5%
Non-cardiac chest pain
5%
Flushing
5%
Blood alkaline phosphatase increased
5%
Hypernatraemia
5%
Neutropenia
5%
Cataract
5%
Abdominal pain upper
5%
Dyspepsia
5%
Oedema
5%
Peripheral swelling
5%
Nasopharyngitis
5%
Rhinitis
5%
Sinusitis
5%
Musculoskeletal chest pain
3%
Hypoxia
3%
Febrile neutropenia
1%
Tachypnoea
1%
Multiple organ dysfunction syndrome
1%
Pain
1%
Clostridium difficile colitis
1%
Erysipelas
1%
Rhabdomyolysis
1%
Pharyngeal cyst
1%
Respiratory failure
1%
Left ventricular dysfunction
1%
Neutropenic colitis
1%
Glioblastoma
1%
Mental status changes
1%
Acute kidney injury
1%
Renal failure
1%
Lung infection
1%
Pneumonia
1%
Pneumonia fungal
1%
Sepsis syndrome
1%
Infection
1%
Septic shock
100%
80%
60%
40%
20%
0%
Study treatment Arm
Moxetumomab Pasudotox 40 µg/kg
Trial Design
1Treatment groups
Experimental Treatment
Group I: DriGo SPTExperimental Treatment1 Intervention
All participants will have the DriGo skin protectant textile applied to their skin fold condition.
Find a Location
Who is running the clinical trial?
Medline IndustriesLead Sponsor
45 Previous Clinical Trials
22,961 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.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.You are 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: DriGo SPT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research study have any available openings for participants?
"As reported on clinicaltrials.gov, this medical trial is not currently recruiting patients - the study was initially published on July 1st 2022 and updated most recently on February 20th 2023. Despite that, there are 21 other studies actively looking for recruits at present."
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