HRIPT for Collagen Dressing

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-31

Study Completion Date

2024-03-22

Brief Summary

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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.

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Detailed Description

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Approximately 75 healthy subjects satisfying all criteria listed below will be enrolled to complete the study with a minimum of 50 subjects. The test product will be applied on the 25-millimeter Hill Top Chamber®, which will be applied directly to the test site. The positive control will be applied to each subject for the first 48 hours only, and the negative control will be applied throughout the study along with the test product. Enough product will be used to cover the chamber. The procedure involves occlusive patching of the test product and control(s) for a minimum of 48 hours followed by an assessment. The procedure will be repeated until a series of 9 consecutive 48-hour exposures have been made over 3 consecutive weeks. This induction phase is followed by an approximate two-week rest period. The challenge phase consists of a challenge or test dose applied once to a previously unexposed test site. Clinical staff will remove the patches 48 hours post-application. Reactions will be scored 30 minutes post-removal, 24-hours post-removal, and 48-hours post-removal. Skin response at each application site will be evaluated according to the Berger and Bowman Scale.

Conditions

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Skin Sensitisation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This will be a single center, with no randomization or blinding, study design in 50 healthy adult subjects, age 18-70 years. Based on prior experience approximately 75 subjects will be enrolled to ensure 50 subjects complete the study.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Collagen wound dressing with positive and negative controls

Application of test dressing, 0.5% sodium lauryl sulfate in distilled water, and distilled water on areas of the back or upper arm.

Group Type EXPERIMENTAL

ColActive Plus Collagen Matrix Dressing

Intervention Type DEVICE

Induction phase: Test article applied with Hill Top chamber every 48+ hours over 3 weeks. Rest phase: 10-day rest period with no application.

Challenge phase: Test article applied for 48 hours and evaluated through 48 hours post removal.

The positive control is evaluated at Induction 1 only. The negative control is applied following the same schedule as the test article.

Interventions

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ColActive Plus Collagen Matrix Dressing

Induction phase: Test article applied with Hill Top chamber every 48+ hours over 3 weeks. Rest phase: 10-day rest period with no application.

Challenge phase: Test article applied for 48 hours and evaluated through 48 hours post removal.

The positive control is evaluated at Induction 1 only. The negative control is applied following the same schedule as the test article.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Age: 18-70
2. Sex: Male \& Female
3. Fitzpatrick: I-V, minimum 10% of panel Fitzpatrick V.
4. Individuals who will be able to read, understand and give an informed consent relating to the study they are participating in.
5. Individuals who will be free of any dermatological or systemic disorder, which in the Investigator's opinion, could interfere with the study results.
6. Individuals who will be in general good health and who will complete a preliminary medical history form mandated by the testing facility.
7. Individuals who will be able to and agree to cooperate with the Investigator and clinical staff.
8. 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.
9. Individuals who have not participated in a similar study in the past 30 days.
10. Individuals who agree to refrain from sun tanning/bathing and prolonged exposure to sunlight (outdoors).
11. Female volunteers who are willing to undergo a urine pregnancy test.
12. 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

1. 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).
2. 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).
3. Individuals who are diagnosed with chronic skin allergies (atopic dermatitis/eczema) or recently treated skin cancer within the last 12 months.
4. 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).
5. Individuals who control their diabetes using insulin.
6. 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.
7. Female volunteers who indicate that they are pregnant or are planning to become pregnant or nursing.
8. Individuals with a known history of hypersensitivity to any cosmetics, personal care products, fragrances, and/or adhesives.
9. Employees of ALS.
10. Individuals with a known fish allergy.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes