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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
43
Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).
Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).
Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).
GSK Investigational Site
Valinhos, Brazil
GSK Investigational Site
Valinhos, Brazil
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).
Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).
Time frame: 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.
Time frame: 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.
Time frame: At Day 4 (48 hours post patch removal)
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
Time frame: At Day 2 (15-30 minutes), Day 3 (24 hours) and Day 4 (48 hours) post patch removal