N/A
N=86
HRIPT for Collagen Dressing
Skin Sensitisation
Bottom Line
View on ClinicalTrials.gov: NCT06283173 ↗Enrolled (actual)
86
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Skin Sensitization Reaction Using Berger and Bowman Scale — 0; 0; 0; 0 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ColActive Plus Collagen Matrix Dressing (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Covalon Technologies Inc.
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Skin Sensitization Reaction Using Berger and Bowman Scale |
0; 0; 0; 0; 0; 0 | — |
Summary
The objectives of this study are to determine by repetitive epidermal contact, the primary or cumulative irritation and the allergic contact sensitization potential of the ColActive Plus Collagen Matrix Dressing, under maximized conditions, with controlled product quantity and application site.
Eligibility Criteria
Inclusion Criteria
- Age: 18-70
- Sex: Male & Female
- Fitzpatrick: I-V, minimum 10% of panel Fitzpatrick V.
- Individuals who will be able to read, understand and give an informed consent relating to the study they are participating in.
- Individuals who will be free of any dermatological or systemic disorder, which in the Investigator's opinion, could interfere with the study results.
- Individuals who will be in general good health and who will complete a preliminary medical history form mandated by the testing facility.
- Individuals who will be able to and agree to cooperate with the Investigator and clinical staff.
- Individuals who will agree to have test products applied in accordance with the protocol and are able to complete the full course of the study.
- Individuals who have not participated in a similar study in the past 30 days.
- Individuals who agree to refrain from sun tanning/bathing and prolonged exposure to sunlight (outdoors).
- Female volunteers who are willing to undergo a urine pregnancy test.
- Individuals who agree to not change their current brand of personal care products such as soaps, body washes, laundry detergents, body sprays, body spritzes, etc. while participating on the study.
Exclusion Criteria
- Individuals who are currently taking any medications (topical or systemic) that may mask or interfere with the test results (specifically, corticosteroids, topical and/or systemic [except nasal steroids], non steroidal anti-inflammatory drugs [e.g. ibuprofen, Advil, Motrin, aspirin > 325mg/day], antihistamines, and topical/oral immunosuppressive medications). Subjects must refrain from using any topical/oral anti-inflammatory medications during the length of the study (6 weeks).
- Individuals who have a history of any acute or chronic disease that might interfere with or increase the risk on study participation. (e.g., systemic lupus erythematosus, rheumatoid arthritis, HIV positive).
- Individuals who are diagnosed with chronic skin allergies (atopic dermatitis/eczema) or recently treated skin cancer within the last 12 months.
- Individuals who have damaged skin in close proximity to test sites (e.g., sunburn, uneven skin pigmentation, tattoos, scars, excessive hair, active acne papules or other disfigurations).
- Individuals who control their diabetes using insulin.
- Individuals with any history, which in the Investigator's opinion, indicates the potential for harm to the subject or places the validity of the study in jeopardy.
- Female volunteers who indicate that they are pregnant or are planning to become pregnant or nursing.
- Individuals with a known history of hypersensitivity to any cosmetics, personal care products, fragrances, and/or adhesives.
- Employees of ALS.
- Individuals with a known fish allergy.
Data sourced from ClinicalTrials.gov (NCT06283173). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.