Trials Sponsors Conditions Drugs Pricing

Conditions

Skin Sensitisation

Outcome Measures

Primary Outcomes (1)

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
48 hours post challenge and 24 hours and 48 hours post-challenge removal

Other Outcomes (1)

Induction Phase Skin Response
Every 48-72 hours for 1 (positive control) or 9 (negative control and test) applications

Study Arms (1)

Collagen wound dressing with positive and negative controls

EXPERIMENTAL

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

Device: ColActive Plus Collagen Matrix Dressing

Interventions

ColActive Plus Collagen Matrix DressingDevice

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.

Collagen wound dressing with positive and negative controls

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age: 18-70
Sex: Male \& Female

Sponsors & Collaborators

ALS Beauty and Personal Care
Industrycollaborator
Covalon Technologies Inc.
Industrylead

Study Sites (1)

ALS Beauty and Personal Care

Torrance, California, 90501, United States

Related Publications (1)

Bowman JP, Berger RS, Mills OH, Kligman AM, Stoudemayer T. The 21-day human cumulative irritation test can be reduced to 14 days without loss of sensitivity. J Cosmet Sci. 2003 Sep-Oct;54(5):443-9.
PMID: 14605686BACKGROUND

Results Point of Contact

Title: Director of Regulatory Affairs
Organization: Covalon Technologies Inc.

Study Officials

Jordan DeSantis, MHI, BS
ALS
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

86 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: OTHER
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 22, 2024

First Posted

February 28, 2024

Study Start

January 31, 2024

HRIPT for Collagen Dressing

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Other Outcomes (1)

Study Arms (1)

Collagen wound dressing with positive and negative controls

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Other Outcomes (1)

Study Arms (1)

Collagen wound dressing with positive and negative controls

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations