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Barrier Film

Cavilon Advanced Skin Protectant for Incontinence Associated Dermatitis

N/A
Waitlist Available
Research Sponsored by 3M
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 21 days depending on length of hospitalization
Awards & highlights

Study Summary

The purpose of the study is to evaluate the safety and efficacy of the investigational product (3M™ Cavilon™ Advanced High Endurance Skin Protectant) for the treatment of incontinence associated dermatitis.

Eligible Conditions
  • Incontinence Associated Dermatitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 21 days depending on length of hospitalization
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 21 days depending on length of hospitalization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent Change From Baseline to End of Study in Incontinence Associated Dermatitis (IAD) Scores
Secondary outcome measures
Pain Scores During Incontinence Management
Prevention of IAD.
Re-epithelialization to a Category 1 or Lower

Side effects data

From 2019 Phase 3 trial • 80 Patients • NCT01829711
39%
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%
Dyspnoea
10%
Insomnia
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%
Oropharyngeal pain
8%
Pruritus
8%
Hypotension
8%
Hyperkalaemia
8%
Hypomagnesaemia
8%
Weight increased
8%
Haemolytic uraemic syndrome
8%
Sinus tachycardia
8%
Dry eye
6%
Haematuria
6%
Infusion related reaction
6%
Dysgeusia
6%
Nasal congestion
6%
Upper respiratory tract infection
6%
Pleural effusion
6%
Blood bilirubin increased
6%
Neutrophil count decreased
6%
Flatulence
6%
Musculoskeletal pain
5%
Rash
5%
Non-cardiac chest pain
5%
Rash maculo-papular
5%
Capillary leak syndrome
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

2Treatment groups
Experimental Treatment
Active Control
Group I: Cavilon Advanced Skin ProtectantExperimental Treatment1 Intervention
Product applicator contains liquid barrier applied on buttocks/thighs with it drying rapidly to durable barrier film. It's applied 3x/per week.
Group II: ConvaTec Sensi-Care Protective BarrierActive Control1 Intervention
Marketed product applied following manufacturer's recommendation. The product is 15% zinc oxide with petrolatum.

Find a Location

Who is running the clinical trial?

3MLead Sponsor
157 Previous Clinical Trials
31,429 Total Patients Enrolled
3 Trials studying Incontinence Associated Dermatitis
611 Patients Enrolled for Incontinence Associated Dermatitis
Pat Parks, MDStudy Director3M
~5 spots leftby Jun 2025
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