Skin Sensitisation
Conditions
Brief 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.
Detailed description
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.
Interventions
DEVICEColActive 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.
Sponsors
ALS Beauty and Personal Care
Covalon Technologies Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin Sensitization Reaction Using Berger and Bowman Scale | 48 hours post challenge and 24 hours and 48 hours post-challenge removal | Inflammatory response graded as 0 through 3: 0=no visible reaction; +=slight, confluent, or patchy erythema; 1=Mild erythema (pink); 2=moderate erythema (definite redness); 3=strong erythema (very intense redness) Definition of letter grades appended to a numerical grade: E = Edema - swelling, spongy feeling when palpated P = Papule - red, solid, pinpoint elevation V = Vesicle - small elevation containing fluid B = Bulla reaction - fluid-filled lesion (blister) S = Spreading - evidence of the reaction beyond the Webril® pad area W = Weeping - result of a vesicular or bulla reaction - serous exudate I = Induration - solid, elevated, hardened, thickened skin Superficial Effects g = Glazing y = Peeling c = Scab, dried film of serous exudate of vesicular or bulla reaction d = Hyperpigmentation (reddish-brown discoloration of test site) h = Hypopigmentation (loss of visible pigmentation at test site) f = Fissuring - grooves in the superficial layers of the skin |
Other
| Measure | Time frame | Description |
|---|---|---|
| Induction Phase Skin Response | Every 48-72 hours for 1 (positive control) or 9 (negative control and test) applications | Assessment of irritation based on the Berger and Bowman scale: Numeric Scores 0 = No evidence of irritation 1. = Minimal erythema, barely perceptible 2. = Moderate erythema, readily visible; or minimal edema; or minimal papular response 3. = Strong erythema; or erythema and papules 4. = Definite edema 5. = Erythema, edema and papules 6. = Vesicular eruption 7. = Strong reaction spreading beyond test site Letter Grades (always upper case) A = Slight glazed appearance B = Marked glazing C = Glazing with peeling and cracking F = Glazing with fissures G = Film of dried serous exudate covering all or a portion of the patch site H = Small petechial erosions and/or scabs Positive control should show a response and negative control should not show a response. |
Countries
United States
Participant flow
Pre-assignment details
All subjects receive the positive control, negative control and test product at the same time. The positive control is only applied at the first visit to ensure the subject responds appropriately to a sensitizer. From then on, both the negative control and test products are applied at the same times at different sites, and both sites are evaluated for a local reaction.
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 57 |
| Total | 57 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not show for first visit | 10 |
| Overall Study | Lost to Follow-up | 12 |
| Overall Study | Physician Decision | 7 |
Baseline characteristics
| Characteristic | Collagen Wound Dressing With Positive and Negative Controls |
|---|---|
| Age, Continuous | 48 years STANDARD_DEVIATION 13 |
| Fitzpatrick Skin Type I - always burn, does not tan | 3 Participants |
| Fitzpatrick Skin Type II - burn easily, tan slightly | 14 Participants |
| Fitzpatrick Skin Type III - burn moderately, tan progressively | 10 Participants |
| Fitzpatrick Skin Type IV - burn a little, always tan | 13 Participants |
| Fitzpatrick Skin Type VI - never burn, tan very intensely | 0 Participants |
| Fitzpatrick Skin Type V - rarely burn, tan intensely | 17 Participants |
| Race/Ethnicity, Customized Race African American | 18 Participants |
| Race/Ethnicity, Customized Race Asian | 10 Participants |
| Race/Ethnicity, Customized Race Caucasian | 11 Participants |
| Race/Ethnicity, Customized Race Hispanic | 14 Participants |
| Race/Ethnicity, Customized Race Other | 4 Participants |
| Region of Enrollment United States | 57 participants |
| Sex: Female, Male Female | 53 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 86 |
| other Total, other adverse events | 1 / 86 |
| serious Total, serious adverse events | 0 / 86 |
Outcome results
Primary
Skin Sensitization Reaction Using Berger and Bowman Scale
Inflammatory response graded as 0 through 3: 0=no visible reaction; +=slight, confluent, or patchy erythema; 1=Mild erythema (pink); 2=moderate erythema (definite redness); 3=strong erythema (very intense redness) Definition of letter grades appended to a numerical grade: E = Edema - swelling, spongy feeling when palpated P = Papule - red, solid, pinpoint elevation V = Vesicle - small elevation containing fluid B = Bulla reaction - fluid-filled lesion (blister) S = Spreading - evidence of the reaction beyond the Webril® pad area W = Weeping - result of a vesicular or bulla reaction - serous exudate I = Induration - solid, elevated, hardened, thickened skin Superficial Effects g = Glazing y = Peeling c = Scab, dried film of serous exudate of vesicular or bulla reaction d = Hyperpigmentation (reddish-brown discoloration of test site) h = Hypopigmentation (loss of visible pigmentation at test site) f = Fissuring - grooves in the superficial layers of the skin
Time frame: 48 hours post challenge and 24 hours and 48 hours post-challenge removal
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Test Article (Collagen Wound Dressing) | Skin Sensitization Reaction Using Berger and Bowman Scale | Mean score at 48 hours post challenge | 0 score on a scale |
| Test Article (Collagen Wound Dressing) | Skin Sensitization Reaction Using Berger and Bowman Scale | Mean score at 24 hours post challenge removal | 0 score on a scale |
| Test Article (Collagen Wound Dressing) | Skin Sensitization Reaction Using Berger and Bowman Scale | Mean score at 48 hours post-challenge removal | 0 score on a scale |
| Negative Control (Distilled Water) | Skin Sensitization Reaction Using Berger and Bowman Scale | Mean score at 48 hours post challenge | 0 score on a scale |
| Negative Control (Distilled Water) | Skin Sensitization Reaction Using Berger and Bowman Scale | Mean score at 24 hours post challenge removal | 0 score on a scale |
| Negative Control (Distilled Water) | Skin Sensitization Reaction Using Berger and Bowman Scale | Mean score at 48 hours post-challenge removal | 0 score on a scale |
Other Pre-specified
Induction Phase Skin Response
Assessment of irritation based on the Berger and Bowman scale: Numeric Scores 0 = No evidence of irritation 1. = Minimal erythema, barely perceptible 2. = Moderate erythema, readily visible; or minimal edema; or minimal papular response 3. = Strong erythema; or erythema and papules 4. = Definite edema 5. = Erythema, edema and papules 6. = Vesicular eruption 7. = Strong reaction spreading beyond test site Letter Grades (always upper case) A = Slight glazed appearance B = Marked glazing C = Glazing with peeling and cracking F = Glazing with fissures G = Film of dried serous exudate covering all or a portion of the patch site H = Small petechial erosions and/or scabs Positive control should show a response and negative control should not show a response.
Time frame: Every 48-72 hours for 1 (positive control) or 9 (negative control and test) applications
Population: Assessment of the positive control was only planned post-application #1 but was also performed post-application #2.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Test Article (Collagen Wound Dressing) | Induction Phase Skin Response | Post-application 1 | 0 score on a scale |
| Test Article (Collagen Wound Dressing) | Induction Phase Skin Response | Post-application 2 | 0 score on a scale |
| Test Article (Collagen Wound Dressing) | Induction Phase Skin Response | Post-application 3 | 0 score on a scale |
| Test Article (Collagen Wound Dressing) | Induction Phase Skin Response | Post-application 4 | 0 score on a scale |
| Test Article (Collagen Wound Dressing) | Induction Phase Skin Response | Post-application 5 | 0 score on a scale |
| Test Article (Collagen Wound Dressing) | Induction Phase Skin Response | Post-application 6 | 0 score on a scale |
| Test Article (Collagen Wound Dressing) | Induction Phase Skin Response | Post-application 7 | 0 score on a scale |
| Test Article (Collagen Wound Dressing) | Induction Phase Skin Response | Post-application 8 | 0 score on a scale |
| Test Article (Collagen Wound Dressing) | Induction Phase Skin Response | Post-application 9 | 0 score on a scale |
| Negative Control (Distilled Water) | Induction Phase Skin Response | Post-application 8 | 0 score on a scale |
| Negative Control (Distilled Water) | Induction Phase Skin Response | Post-application 7 | 0 score on a scale |
| Negative Control (Distilled Water) | Induction Phase Skin Response | Post-application 5 | 0 score on a scale |
| Negative Control (Distilled Water) | Induction Phase Skin Response | Post-application 1 | 0 score on a scale |
| Negative Control (Distilled Water) | Induction Phase Skin Response | Post-application 3 | 0 score on a scale |
| Negative Control (Distilled Water) | Induction Phase Skin Response | Post-application 4 | 0 score on a scale |
| Negative Control (Distilled Water) | Induction Phase Skin Response | Post-application 9 | 0 score on a scale |
| Negative Control (Distilled Water) | Induction Phase Skin Response | Post-application 2 | 0 score on a scale |
| Negative Control (Distilled Water) | Induction Phase Skin Response | Post-application 6 | 0 score on a scale |
| Positive Control (0.5% Sodium Lauryl Sulfate) | Induction Phase Skin Response | Post-application 1 | 0.6 score on a scale |
| Positive Control (0.5% Sodium Lauryl Sulfate) | Induction Phase Skin Response | Post-application 2 | 0.5 score on a scale |