To Investigate Primary Irritation Potential of Four Skin Serum Products on Human Subjects Assessed by 24 Hour Patch Test

Study Overview
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Brief Summary
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To assess the irritation potential of four prototype daily defense serum formulations after 24 (± 2) hours under semi-occlusive patch application to the skin of healthy volunteers.

Detailed Description
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This is an evaluator (single) blind, test site randomized and intra-subject comparison patch test study to evaluate the cutaneous irritation potential of four experimental daily defense serum formulations, including a saline solution as a negative control.

Official Title
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A Human Subject 24 Hour Patch Test to Assess the Irritation Potential of Four Skin Serum Products

Conditions
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Skin Care

Intervention / Treatment
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* Other: Experimental Daily Defense Serum A
* Other: Experimental Daily Defense Serum C
* Other: Experimental Daily Defense Serum G
* Other: Experimental Daily Defense Serum N
* Other: Saline Solution Sodium Chloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form. General health: Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon physical examination and participants must have intact skin on the proposed application site; dorsum (scapular region). Fitzpatrick photo type I to IV. Agreement to comply with the procedures and requirements of the study and to attend the scheduled assessment visits. Exclusion Criteria: Women who are known to be pregnant or who are intending to become pregnant over the duration of the study. Women who are breast-feeding. Any history of significant dermatological diseases or conditions or medical conditions known to alter skin appearance or physiologic response (e.g. diabetes,) which could, in the opinion of the Investigator, preclude topical application of the investigational products and/or interfere with the evaluation of the test site reaction. Presence of open sores, pimples, or cysts at the application site. Active dermatosis (local or disseminated) that might interfere with the results of the study Considered immune compromised. History of diseases aggravated or triggered by ultraviolet radiation. Participants with dermatographism. Currently using any medication which in the opinion of the investigator, may affect the evaluation of the study product, or place the participant at undue risk. Use of the following topical or systemic medications: immunosuppressants, antihistamines, non-hormonal anti-inflammatory drugs, and corticosteroids up to 2 weeks before Screening visit. Oral or topical treatment with vitamin A acid and/or its derivatives up to 1 month before the screening visit. Intention of being vaccinated during the study period or vaccination within 3 weeks of the Screening visit. Currently receiving allergy injections, or due to receive an injection within 7 days prior to Visit 1, or expects to begin injections during study participation. Previous history of atopy, allergic reactions, irritation or intense discomfort feelings to topical-use products, cosmetics or medication. Known or suspected intolerance or hypersensitivity to any of the study materials (or closely related compounds) or any of their stated ingredients, including any component of the patches. History of sensitization in a previous patch study. Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the Screening visit. Previous participation in this study. Recent history (within the last 5 years) of alcohol or other substance abuse. Intense sunlight exposure or sun tanning sessions up to 30 days before the Screening evaluation Intention of bathing, sauna, water sports, or activities that lead to intense sweating. Any participant who, in the judgment of the Investigator, should not participate in the study. Any skin marks on the test site that might interfere with the evaluation of possible skin reactions (e.g. pigmentation disorders, vascular malformations, scars, tattoos, excessive hair, numerous freckles). Prisoner or involuntary incarcerated participant. Participant from an indigenous tribe. An employee of the sponsor or the study site or members of their immediate family.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Product 1<br>Participants will topically apply test product 1 via semi occlusive patch. | Other: Experimental Daily Defense Serum A<br>* Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).<br>|
| Experimental: Test Product 2<br>Participants will topically apply test product 2 via semi occlusive patch. | Other: Experimental Daily Defense Serum C<br>* Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).<br>|
| Experimental: Test Product 3<br>Participants will topically apply test product 3 via semi occlusive patch. | Other: Experimental Daily Defense Serum G<br>* Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).<br>|
| Experimental: Test Product 4<br>Participants will topically apply test product 4 via semi occlusive patch. | Other: Experimental Daily Defense Serum N<br>* Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).<br>|
| Sham Comparator: Reference Product<br>Participants will topically apply Reference product via semi occlusive patch. | Other: Saline Solution Sodium Chloride<br>* Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Dermal Response Score at 15-30 Minutes Post Patch Removal | Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 15-30 minutes following patch removal on Day 2 post 24 hrs of patch application. Response score from 0 to 7; 0= No evidence of irritation, 1= Minimal erythema, barely perceptible, 2= Definite erythema, readily visible; minimal edema or minimal papular response, 3= Erythema and papules, 4= Definite edema, 5= Erythema, edema and papules, 6= Vesicular eruption, 7= Strong reaction spreading beyond test site. | At Day 2 (15-30 minutes post patch removal) | 
| Frequency of Dermal Response Score at 24 Hours Post Patch Removal | Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 24 hours following patch removal on Day 3 post 48 hrs of patch application. Response score from 0 to 7; 0= No evidence of irritation, 1= Minimal erythema, barely perceptible, 2= Definite erythema, readily visible; minimal edema or minimal papular response, 3= Erythema and papules, 4= Definite edema, 5= Erythema, edema and papules, 6= Vesicular eruption, 7= Strong reaction spreading beyond test site. | At Day 3 (24 hours post patch removal) | 
| Frequency of Dermal Response Score at 48 Hours Post Patch Removal | Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 48 hours following patch removal on Day 4 post 72 hours of patch application. Response score from 0 to 7; 0= No evidence of irritation, 1= Minimal erythema, barely perceptible, 2= Definite erythema, readily visible; minimal edema or minimal papular response, 3= Erythema and papules, 4= Definite edema, 5= Erythema, edema and papules, 6= Vesicular eruption, 7= Strong reaction spreading beyond test site. | At Day 4 (48 hours post patch removal) | 
| Average Dermal Response Score at 30 Minutes Post Patch Removal | Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 15-30 minutes following patch removal on Day 2 post 24 hours of patch application. Response score from 0 to 7; 0= No evidence of irritation, 1= Minimal erythema, barely perceptible, 2= Definite erythema, readily visible; minimal edema or minimal papular response, 3= Erythema and papules, 4= Definite edema, 5= Erythema, edema and papules, 6= Vesicular eruption, 7= Strong reaction spreading beyond test site. | At Day 2 (15-30 minutes post patch removal) | 
| Average Dermal Response Score at 24 Hours Post Patch Removal | Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 24 hours following patch removal on Day 3 post 48 hours of patch application. Response score from 0 to 7; 0= No evidence of irritation, 1= Minimal erythema, barely perceptible, 2= Definite erythema, readily visible; minimal edema or minimal papular response, 3= Erythema and papules, 4= Definite edema, 5= Erythema, edema and papules, 6= Vesicular eruption, 7= Strong reaction spreading beyond test site. | At Day 3 (24 hours post patch removal) | 
| Average Dermal Response Score at 48 Hours Post Patch Removal | Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 48 hours following patch removal on Day 4 post 72 hours of patch application. Response score from 0 to 7; 0= No evidence of irritation, 1= Minimal erythema, barely perceptible, 2= Definite erythema, readily visible; minimal edema or minimal papular response, 3= Erythema and papules, 4= Definite edema, 5= Erythema, edema and papules, 6= Vesicular eruption, 7= Strong reaction spreading beyond test site. | At Day 4 (48 hours post patch removal) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Combined Skin Irritation (Dermal Response) Scores at 30 Minutes, 24 Hours and 48 Hours Post Patch Removal | A trained assessor assessed all patch sites.Following scores were used to express response observed at time of examination:0=No evidence of irritation,1=Minimal erythema;barely perceptible,2=Definite erythema,readily visible;or minimal edema; or minimal papular response,3=Erythema and papules,4=Definite edema,5=Erythema, edema,and papules,6=Vesicular eruption,7=Strong reaction spreading beyond test site.Other features indicative irritation (Superficial irritation) scores were:GradeA/Score0=Slight glazed appearance,GradeB/Score1=Marked glazing,GradeC/Score2=Glazing with peeling and cracking,GradeF/Score3=Glazing with fissures,Grade G/Score 3=Film of dried serous exudate covering all or portion of patch,Grade H/Score3=Small petechial erosions and/or scabs.The letter grades were converted to scores.Superficial irritation scores were only provided if there was a dermal response score >0.No effect is 0 score(i.e. no evidence).Full Range 0-10.Lower score indicates better product tolerabily | At Day 2 (15-30 minutes), Day 3 (24 hours) and Day 4 (48 hours) post patch removal |