Human Repeat Insult Patch Test (HRIPT): Assessment of Primary and Cumulative Skin Irritation and Skin Sensitization of a Product, Under Controlled and Maximized Conditions
Phase: NA
Conditions: Skin Sensitisation
Sponsor: Covalon Technologies Inc.

Protocol approved 2/27/2024

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TABLE OF CONTENTS 
 
Page 
TABLE OF CONTENTS....................................................................................................................................... 2 
1. ABBREVIATION AND DEFINITION LIST ......................................................................................................... 3 
2. OBJECTIVE ................................................................................................................................................... 4 
3. QUALITY REVIEW AND VERIFICATION ......................................................................................................... 4 
4. BACKGROUND 1, 2 ........................................................................................................................................ 4 
5. TEST PRODUCT ............................................................................................................................................ 4 
6. SUBJECT SELECTION CRITERIA ..................................................................................................................... 5 
6.1 INCLUSION CRITERIA ................................................................................................................................. 5 
6.2 EXCLUSION CRITERIA................................................................................................................................. 5 
7. INFORMED CONSENT FORM AND MEDICAL HISTORY FORM ....................................................................... 6 
8. EXPERIMENTAL TECHNIQUES AND METHODS ............................................................................................. 6 
9. PROCEDURE ................................................................................................................................................ 7 
9.1 Consent ..................................................................................................................................................... 7 
9.2 Method of Application: .............................................................................................................................. 7 
9.3 Test Products: ........................................................................................................................................... 7 
9.4 Test Product Preparation ........................................................................................................................... 7 
9.5 Test Sites/ Procedure: ................................................................................................................................ 8 
10. SUBJECT DISCONTINUATION ..................................................................................................................... 8 
11. ADVERSE EVENTS ...................................................................................................................................... 9 
12. PROTOCOL AMENDMENT.......................................................................................................................... 9 
13. STUDY REPORT .......................................................................................................................................... 9 
14. DATA REPORTING ................................................................................................................................... 10 
15. RECORDS RETENTION .............................................................................................................................. 10 
16.  ACCEPTANCE OF PROTOCOL ................................................................................................................... 11 
APPENDIX I: .................................................................................................................................................. 13 
APPENDIX II: ................................................................................................................................................. 14 
 
 
 
 
 

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1. ABBREVIATION AND DEFINITION LIST 
 
µg/cm2 
Micrograms Per Square Centimeter 
AE 
Adverse Event 
Ave. 
Avenue 
cm 
Centimeter 
Dr. 
Doctor 
e.g 
For Example 
GCP 
Good Clinical Practices. 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonisation 
LTDA 
Limited 
PDF 
Portable Document Format 
SAE 
Serious Adverse Event 
SOP 
Standard Operating Procedure 
Test Article/Product 
These terms may appear interchangeably in the protocol and are defined as the test 
article/product used in the study 
Subject/Participant 
These terms may appear interchangeably in the protocol and are defined as the 
individual(s) that will participate in the study.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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known health risk when used as intended.  The test articles will be stored in a secured location with the temperature 
monitored until use. 
 
Upon arrival at ALS the test product will be assigned a unique laboratory code number and entered into a daily log 
identifying the lot number, sample description, sponsor, date received, and tests requested. 
 
Sample will be retained for a minimum of 30 days beyond submission of final report. Sample disposition will be 
conducted in compliance with appropriate federal, state and local ordinances. 
 
6. SUBJECT SELECTION CRITERIA 
 
Approximately 75 healthy subjects satisfying all criteria listed below will be enrolled to complete the study with a 
minimum of 50 subjects.  
 
6.1 Inclusion Criteria  
 
Individuals included in the study will be enrolled based upon the following 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. 
 
6.2 Exclusion Criteria 
 
Individuals meeting any of the following criteria will be excluded from study participation.  
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. 

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10. Individuals with a known fish allergy.  
 
7. INFORMED CONSENT FORM AND MEDICAL HISTORY FORM 
 
An informed consent will be obtained from each subject consistent with requirements in 21 CFR 50 prior to initiating 
the study describing reasons for the study, possible adverse effects, associated risks and potential benefits of the 
treatment and their limits of liability. Subjects will sign and date the informed consent document to indicate their 
authorization to proceed and acknowledge their understanding of the contents. Each subject will be sent home with a 
signed and dated copy of the informed consent form. Each subject will be assigned a subject identification number 
and medical history information will be collected. This information, along with the signed consent forms will be 
available for inspection on the premises of ALS only. 
 
8. EXPERIMENTAL TECHNIQUES AND METHODS 
 
Skin response to the test product will be evaluated according to the Berger and Bowman6 Scale listed below. 
 
Induction Phase (Berger and Bowman1 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 
 
Challenge Phase 
Inflammatory Responses 
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 

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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 
 
Each of the scores represents the presence of a clinically significant effect that is localized in a 
representative portion of the patch area, defined as 25% or more of the patch site. Questionable 
(barely perceptible, minimal or involving less than 25% of the patch site) reactions as well as the 
+ designation are inconclusive and are not included in calculation. 
 
9. PROCEDURE 
 
9.1 Consent 
 
Subjects will be given an informed consent form (ICF) to read and sign.  They will have all of their study related 
questions answered by the Investigator or designated staff. Subjects who qualify based on the inclusion and exclusion 
criteria will be enrolled into the study.   
 
9.2 Method of Application:  
 
Occlusive – Test products to be studied under occlusive conditions will be applied on a 25-millimeter Hill Top 
Chamber®, consisting of an outer ring and an inner, flexible flange.  Within the chamber is a non-woven Webril ® 
pad.  The chamber is surrounded by a Durapore® semi-occlusive, hypoallergenic adhesive tape. 
 
 9.3 Test Products:  
 
The test product will be applied on the 25-millimeter Hill Top Chamber®, which will be applied directly to the test 
site. Enough product will be used to cover the chamber.   
 
Positive Control: 
0.5% sodium lauryl sulfate (Sigma Chemicals, St. Louis, Missouri) in distilled water will be applied as a positive 
control.  Positive control is applied on the same type of occlusive patch as the test product and is applied to the 
intrascapular region of the subjects’ back.  Positive control remains on the subjects’ skin for 48 hours.  The patch is 
removed, and the positive control site will be evaluated according to the Berger and Bowman6 Scale by a trained 
ALS staff member.  Positive reactions are notated and reported in final report.  Positive Control will only be applied 
for Induction 1. 
 
Negative Control: 
Distilled water will be applied as a negative control. Negative control is applied on the same type of occlusive patch 
as the test product and is applied intrascapular regions of the subjects’ back.  Negative control remains on the 
subject skin for 48-72 hours.  The patch is removed and will be evaluated according to Berger and Bowman6 Scale 
by a trained ALS staff member.  Positive reactions are notated and reported in final report.  Subjects who observe a 
positive reaction are dropped from the study.  The negative control will be applied throughout the entire study along 
with test product. 
 
9.4 Test Product Preparation 
 
Test Product Preparation will be performed as noted below unless otherwise requested by Sponsor. 
Prepare ColActive Plus Collagen Matrix Dressing samples using the following method: 
 
Step 1:  ColActive Plus Collagen Matrix Dressing: cut with sterile scissors to fit the chamber of the patch (25-
millimeter diameter).  
Step 2:  Place the test article directly on the Hill Top Chamber®. 
   Step 3:  0.8mL of distilled water will be dispensed to saturate the test product.* 

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   Step 4:  Place a Hill Top Chamber® on the test site. 
 *Visual inspection will be done to confirm the entire test article has come in contact with distilled water and test 
product has transformed into a gel.  
  
9.5 Test Sites/ Procedure:  
 
The patches will be applied directly to the skin of the intrascapular regions of the back, to the right and/or left of the 
midline, and/or upper arms. 
 
Subjects will be given a Panelist Instructions for the Safety Patch Test. Subjects will be dismissed with instructions 
to keep the test area dry while the patches are in place and to not expose the test area to direct sunlight.  Subjects 
will be instructed to notify clinical staff during the course of the study should they begin using any new medications, 
cease taking any medications or have any change in their medical condition. 
 
Patches will remain in place for a minimum of 48 hours. Subjects will be instructed to not remove the patches prior 
to their next scheduled visit.  Subjects patched on Friday will have patches remain on until the following Monday 
(72 hours).  The procedure will be repeated until a series of 9 consecutive 48-hour exposures have been made over 3 
consecutive weeks. This is considered the induction phase. 
 
Before each re-application, the test sites will be visually evaluated for any reaction. 
 
Following the induction phase, subject will be given a minimum of 10-day rest period.   
 
A challenge or test dose will be 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.   The skin grader will be blinded to the treatment assignments and any previous scores. 
 
Skin response to the test product will be evaluated according to the Berger and Bowman6 Scale (Section 8. 
Experimental Techniques and Methods). 
 
The Sponsor will be notified within 1-2 business days of any subject who:  
•exhibits an erythema score of 2 or greater 
•exhibits papules, vesicles, bullae and/or spreading beyond the patch site, regardless of the degree of erythema 
•requires follow-up 
 
If any subject exhibits a grade 2 during induction phase, the test site will be changed.  If the subject shows another 
grade 2 of the same test product during induction phase at the new test site, the test product will be discontinued for 
safety concerns. If any subject shows a grade 3 or greater during induction phase, the test site will be discontinued 
for safety concerns. 
 
If any subject shows a significant reaction at the 30 minutes post-removal, 24-hours post-removal, or 48-hours post-
removal evaluation during the challenge phase (Grade 1, 2, and 3 only), the Investigator may decide to schedule a 
re-challenge patch test for confirmatory purposes.  This follow-up investigation will be conducted approximately 4-8 
weeks after the completion of the challenge phase and will be identical to the challenge phase. 
 
In the event of a re-challenge patch the original test substance should be applied under the same testing conditions 
(concentration and patch type) to confirm delayed contact hyper-reactivity. Related substances (product 
reformulations, individual ingredients, ingredient groups, etc.) can also be applied to aid in determining the 
causative relationship but must be pre-approved prior to application. 
 
 
10. SUBJECT DISCONTINUATION 
 
The removal of a study subject by the Principal Investigator could occur due to the following reasons: 
1. Adverse Event 
2. Concomitant treatments or illnesses incompatible with the study 

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3. Withdrawal of consent by the participant 
a. 
All subjects will be informed of the fact that they may, of their own free will, withdraw 
their consent to participate in the study, if they so wish. 
4. Loss of follow-up 
5. Emergence of a non-inclusion criterion 
6. Researchers' decision 
7. Protocol violation 
 
Those subjects who, for some reason, are discontinued from the study will not be replaced. Data from these subjects 
will not be analyzed unless the reason for their discontinuation was related to the investigational product. 
The Investigator should carefully track and document all premature discontinuations and their reasons on study 
documentation and also, when necessary, on the "adverse event" form, as well as on the study documentation. 
 
11. ADVERSE EVENTS 
 
The most commonly observed reactions in this study are: 
1.  Itching, redness, rash, peeling, swelling and in rare cases blistering. 
2.  There is also a possibility of getting a reaction from the tape possible resulting in hyperpigmentation.  
There also may be risks and discomforts, which are not yet known. 
 
An adverse event (AE) is any unfavorable medical occurrence experienced by the subject, whether or not the event 
may be related to the test article.  
 
Each adverse event must be promptly recorded and sufficiently documented by the Study Director in the source 
documentation and case report form even if the adverse event is assessed by the Study Director as unlikely to be 
related to the study. Adverse events are graded on a scale of severity (mild, moderate, severe, or lift threatening) and 
on a scale of relationship to the product (unknown, unrelated, unlikely, possible, probable, or definite). All adverse 
events will be reported to the Sponsor within five business days.  All adverse events will be followed up until 
resolved, stabilized, the subject is lost to follow-up or the event is otherwise explained.  All follow-up information 
should be reported to the Sponsor. 
 
A serious adverse event (SAE) as defined in the CFR 312.32 is "any experience that is fatal or life threatening, is 
permanently disabling, requires inpatient hospitalization, or is a congenital anomaly, cancer, or overdose". All 
serious adverse events will be reported to the Sponsor within 24 hours of ALS Beauty & Personal Care notification.   
 
If, according to the Investigator, medical care is warranted, appropriate referrals will be made. ALS Beauty & 
Personal Care will follow adverse events until resolution. 
 
12. PROTOCOL AMENDMENT 
 
Any changes to the study protocol will be approved in writing by the client and ALS then submitted to the IRB for 
approval prior to implementation in the study, unless immediate change is necessary to eliminate hazard to the 
subject(s).  Any violations in the study conduct will be documented as protocol deviations.  Protocol amendments will 
be signed by the Investigator and Sponsor representative.   
 
13. STUDY REPORT 
 
A final report will be issued to the sponsor within 4 weeks of study completion. 
 

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14. DATA REPORTING 
 
Skin responses to the test product for each subject will be presented in a table in the final report. Product reporting for 
skin irritation will be based on scores after the first 48hour patch removal. Product reporting for skin sensitization 
(contact allergy) will be based on scores after the 72hour patch removal of challenge phase. 
 
15. RECORDS RETENTION 
 
All original samples, raw data sheets, technician’s notebooks, correspondence files, a copy of final report and 
remaining specimens will be maintained on the premises of the clinic in limited access marked storage files. A 
duplicate copy of the final report will be separately archived at ALS. All records pertaining to this study will be 
retained by ALS, for a period of not less than six (6) years following the submission of the final report. 
 
 

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16.  ACCEPTANCE OF PROTOCOL 
 
 
_________________ 
Covalon Technologies Ltd. 
 
 
 
 Date 
 
 
 
 
 
_________________ 
Principal Investigator 
 
 
 
               Date 
 
 
 
 
 
 
2/27/2024
2/14/2024

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REFERENCES 
 
1. 21 CFR. Ch.1. Part 50, Subpart B. 
2. Weltfriend S, Ramon M, and Maibach H. Irritation Dermatitis, In Dermatotoxicology, 6th edition, CRC 
press, 2004, pp.181-235. 
3. Contact Dermatitis, Dermatology, Volume 1, 2nd edition, by S Moschella MD, H Hurley MD, W.B 
Saunders, Company, 1985. 
4. Fischer T, and Maibach HI. Finn chamber patch test technique. Contact Dermatitis .11:137-40. 1984. 
5. Rietschel, R.L., Fowler, J.F., Ed., Fisher’s Contact Dermatitis (fourth Ed.). Baltimore, Williams & 
Wilkins, 1995. 
6. Berger, R.S., Bowman, J.P. (1982). A reappraisal of the 21-day cumulative irritation test in man. J. 
Toxicol. Ot. & Ocular Toxicol. 1(2);109-115. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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APPENDIX I: 
QUESTIONNAIRE FOR SUBJECT RECRUITMENT HRIPT 
Study Number: 23-401  
 
Subject ID:    
 
Fitz: _______    
Subject Initials:  
 
 
 
Age:    
(18-70)  Date of Birth:  ___________ Race: ______ Sex: ______   
 
 
 
Test Site:  Upper Arms and Back 
Circle Response 
1. 
Do you understand that this is a pre-screening recruitment and does not guarantee you will be 
enrolled on the study?  The study is enrolled on a first come first serve basis. 
YES        NO 
2. 
Do you have a history of hypersensitivity or allergic reactions to any cosmetics, personal care 
products, fragrances, adhesives and/or a known allergy to fish? 
YES        NO 
3. 
Are you willing to have your back photographed? 
YES        NO 
4. 
Have you participated in any study involving the same test site in the past 30 days?  
YES        NO 
5. 
Do you have damaged skin on or in close proximity to test sites (e.g., sunburn, excessive hair, 
back acne, uneven skin pigmentation, tattoos, scars or other disfigurations)? 
YES        NO 
6. 
Do you agree to refrain from swimming, sun bathing and prolonged exposure to sunlight 
(outdoors) during the length of the study? 
YES        NO 
7. 
Have you been diagnosed with any of the following that might interfere with or increase the risk on study participation? 
a. 
active or chronic skin allergies (atopic dermatitis/eczema) 
YES             NO 
b. 
acute or chronic diseases 
YES             NO 
c. 
recently treated skin cancer within the last 12 months  
YES             NO 
d. 
are you insulin dependent for diabetes?                                            
YES            NO 
10.  Are you pregnant, or nursing or planning to get pregnant?       
YES     NO    MALE 
10a. For Females ONLY, please list your method of birth control: ____________________ 
11.   Do you agree to refrain from using any topical/oral anti-inflammatory medications (i.e. 
Tylenol, Aspirin, Ibuprofen, Naproxen) or/and anti-histamines and/or immunosuppressive 
medication during the length of the study (6 weeks)? 
YES             NO 
12.  Are you willing to wear the patches the entire study as instructed?   
YES             NO 
13.   Do you agree to protect the patch during the length of the study (6 weeks) from water and/or 
damage? 
YES             NO 
 
Recruited by: _____________________           Verified by: ___________________ 
                               Initial/Date    
 
 
 
Initial/Date   

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APPENDIX II: 
23-401 A QUESTIONNAIRE FOR SUBJECT ENROLLMENT 
 
       Subject ID: _________ 
 
 
Subject Initials: __________ 
 
1) Are you aware that this study involves research?  
 
YES / NO (circle one) 
2) How long is your study participation? 
 
 
 
__________________ 
3) For the first 9 patching visits, where will the patches containing test product be applied? 
__________ 
4) For the visit 11, where will the patches containing test product be applied? ______________ 
5) Female volunteers:    
Are you pregnant, or nursing or planning to get pregnant?     YES   /   NO   /   MALE   (circle one) 
 
If of child bearing potential, list means of birth control subject agrees to use while participating on study.
 
 
 
_____________________________________________________________________ 
6) What are some possible side reactions expected from this study?    
 
 
 
7) How many total visits will you make to the facility?   __________________________ 
 
8) What is the expected duration of the testing visits? ___________ 
9) You have been given a study calendar for the required visit dates and the open patch hours.  Are 
you able to make all required dates and open hours listed? 
 
 
 
 
 
 
 
 
YES / NO (circle one) 
10) Do you understand that you will be discontinued from the study without full compensation if you 
fail to complete all required study visits? 
 
 
 
 
 
 
 
 
 
YES / NO (circle one) 
11) Do you understand the reminder calls and emails are a courtesy and not a requirement of the 
facility, you will be responsible to making the required visits listed on the calendar? 
 
 
 
 
 
 
 
 
 
YES / NO (circle one) 
12) Have all your questions about the study process been answered? YES / NO (circle one) 
 
L: ________ 
b*________   Fitzpatrick Score: _______ (I-V) 
 
 
                                                                                                                                                 
       ALS Staff Initial               Date                                       Subject Initial               Date