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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Product 1 | Experimental | Participants will topically apply test product 1 via semi occlusive patch. |
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| Test Product 2 | Experimental | Participants will topically apply test product 2 via semi occlusive patch. |
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| Test Product 3 | Experimental | Participants will topically apply test product 3 via semi occlusive patch. |
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| Test Product 4 | Experimental | Participants will topically apply test product 4 via semi occlusive patch. |
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| Reference Product | Sham Comparator | Participants will topically apply Reference product via semi occlusive patch. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental Daily Defense Serum A | Other | Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region). |
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| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| GSK Clinical Trials | GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Valinhos | 13271-130 | Brazil | |||
| GSK Investigational Site |
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 46 participants were screened, out of which 3 participants did not meet study criteria, 43 participants were enrolled in the study out of which 3 participants withdrew their consent. Remaining 40 participants were randomized to the study.
All the participants were enrolled at one center in Brazil.
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Participants | All participants enrolled in the study received all the study products. Test and control products were applied to a paper disc (or cell) contained within an adhesive patch in a randomized manner. The number of cells available on the patch test tape is 6 (but only 5 cells were used, 4 test and 1 reference products). The patch was then applied onto the dorsum (scapula region) of each participant for a period of 24 ± 2 hours, the sequence of the product application to the cells was as per the randomization schedule. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 7, 2017 | Apr 11, 2018 |
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| Experimental Daily Defense Serum C | Other | Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region). |
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| Experimental Daily Defense Serum G | Other | Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region). |
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| Experimental Daily Defense Serum N | Other | Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region). |
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| Saline Solution Sodium Chloride | Other | Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region). |
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| 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) |
| At Day 2 (15-30 minutes), Day 3 (24 hours) and Day 4 (48 hours) post patch removal |
| Valinhos |
| 13271- |
| Brazil |
| Test Product 1 |
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| Test Product 2 |
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| Test Product 3 |
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| Test Product 4 |
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| Reference Product |
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| COMPLETED | 1 participant lost to follow-up was removed from all the treatment arms. |
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| NOT COMPLETED |
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Baseline population reflects the safety population. The safety population (N= 40) included all participants who received any of the test products
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Participants | All participants randomized to the study. Test and control products were applied to a paper disc (or cell) contained within an adhesive patch. The number of cells available on the patch test tape is 6 (but only 5 cells were used, 4 test and 1 reference products). The patch was then applied onto the dorsum (scapula region) of each participant for a period of 24 ± 2 hours, the sequence of the product application to the cells was as per the randomization schedule. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The ITT (N= 39) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available. | Posted | Count of Participants | Participants | At Day 2 (15-30 minutes post patch removal) |
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| Primary | 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. | The ITT (N= 39) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available. | Posted | Count of Participants | Participants | At Day 3 (24 hours post patch removal) |
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| Primary | 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. | The ITT (N= 39) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available. | Posted | Count of Participants | Participants | At Day 4 (48 hours post patch removal) |
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| Primary | 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. | The ITT (N= 39) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available. | Posted | Mean | Standard Deviation | Score on Scale | At Day 2 (15-30 minutes post patch removal) |
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| Primary | 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. | The ITT (N= 39) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available. | Posted | Mean | Standard Deviation | Score on Scale | At Day 3 (24 hours post patch removal) |
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| Primary | 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. | The ITT (N= 39) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available. | Posted | Mean | Standard Deviation | Score on scale | At Day 4 (48 hours post patch removal) |
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| Secondary | 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 | The ITT (N= 39) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available. | Posted | Count of Participants | Participants | At Day 2 (15-30 minutes), Day 3 (24 hours) and Day 4 (48 hours) post patch removal |
|
Approximately 4 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test Product 1 | This arm includes data from the test sites where test product 1 was applied. | 0 | 40 | 0 | 40 | 0 | 40 |
| EG001 | Test Product 2 | This arm includes data from the test sites where test product 2 was applied. | 0 | 40 | 0 | 40 | 0 | 40 |
| EG002 | Test Product 3 | This arm includes data from the test sites where test product 3 was applied. | 0 | 40 | 0 | 40 | 0 | 40 |
| EG003 | Test Product 4 | This arm includes data from the test sites where test product 4 was applied. | 0 | 40 | 0 | 40 | 0 | 40 |
| EG004 | Reference Product | This arm includes data from the test sites where reference product was applied. | 0 | 40 | 0 | 40 | 0 | 40 |
| EG005 | Overall Participants | All participants randomized to the study. Test and control products were applied to a paper disc (or cell) contained within an adhesive patch. The number of cells available on the patch test tape is 6 (but only 5 cells were used, 4 test and 1 reference products). The patch was then applied onto the dorsum (scapula region) of each participant for a period of 24 ± 2 hours, the sequence of the product application to the cells was as per the randomization schedule | 0 | 40 | 0 | 40 | 0 | 40 |
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GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 31, 2017 | Apr 17, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D012462 | Saline Solution, Hypertonic |
| ID | Term |
|---|---|
| D006982 | Hypertonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| 0 |
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| 1 |
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| 2 |
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| 3 |
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| 4 |
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| 5 |
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| 6 |
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| 7 |
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| OG003 |
| Test Product 4 |
This arm includes data from the test sites where test product 4 was applied. |
| OG004 | Reference Product | This arm includes data from the test sites where reference product was applied. |
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| OG003 |
| Test Product 4 |
This arm includes data from the test sites where test product 4 was applied. |
| OG004 | Reference Product | This arm includes data from the test sites where reference product was applied. |
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| OG003 | Test Product 4 | This arm includes data from the test sites where test product 4 was applied. |
| OG004 | Reference Product | This arm includes data from the test sites where reference product was applied. |
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| OG003 |
| Test Product 4 |
This arm includes data from the test sites where test product 4 was applied. |
| OG004 | Reference Product | This arm includes data from the test sites where reference product was applied. |
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| OG003 |
| Test Product 4 |
This arm includes data from the test sites where test product 4 was applied. |
| OG004 | Reference Product | This arm includes data from the test sites where reference product was applied. |
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This arm includes data from the test sites where test product 2 was applied. |
| OG002 | Test Product 3 | This arm includes data from the test sites where test product 3 was applied. |
| OG003 | Test Product 4 | This arm includes data from the test sites where test product 4 was applied. |
| OG004 | Reference Product | This arm includes data from the test sites where reference product was applied. |
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| Missing |
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| Grade A/Score 0 |
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| Grade B/Score 1 |
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| Grade C/Score 2 |
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| Grade F/Score 3 |
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| Grade G/Score 3 |
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| Grade H/Score 3 |
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| Missing |
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| Grade A/Score 0 |
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| Grade B/Score 1 |
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| Grade C/Score 2 |
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| Grade F/Score 3 |
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| Grade G/Score 3 |
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| Grade H/Score 3 |
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