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To Assess the Photosensitisation and Photoallergy Potential of a Cosmetic Facial Product in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03183518
Recruitment Status : Completed
First Posted : June 12, 2017
Results First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Basic Science
Condition Skin Care
Interventions Other: Facial micellar cleanser
Other: Saline Solution: Sodium Chloride (NaCl; 0.9%)
Enrollment 48
Recruitment Details All participants were enrolled at one center in Brazil.
Pre-assignment Details A total of 49 participants were screened, out of which 1 participant did not meet study criteria. Remaining 48 participants were enrolled in the study, out of which 12 participants withdrew their consent before randomization.
Arm/Group Title All Participants
Hide Arm/Group Description Included all participants who were randomized to receive the study treatment. In this study, the test product (cosmetic facial cleanser) and the negative control (saline solution) were randomly assigned and dispensed to 2 separated cells within a single semi-occlusive patch that was subsequently applied to the upper back (test site).
Period Title: Overall Study
Started 36
Test Product [1] 36
Negative Control [1] 36
Completed 33
Not Completed 3
Reason Not Completed
Other (Not specified)             2
Other (Withdrawal of consent)             1
[1]
All participants received both the study treatments in single semi-occlusive patch
Arm/Group Title All Participants
Hide Arm/Group Description Baseline population includes safety population (N=36). The Safety population included all participants who received any study product.
Overall Number of Baseline Participants 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants
40.6  (11.40)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
Female
29
  80.6%
Male
7
  19.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   2.8%
White
35
  97.2%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 2
Hide Description A trained assessor assessed all patch sites. The following scores were used to express the response observed at the 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: Grade A/Score 0=Slight glazed appearance, Grade B/Score 1=Marked glazing, Grade C/Score 2=Glazing with peeling and cracking, Grade F/Score 3=Glazing with fissures, Grade G/Score 3=Film of dried serous exudate covering all or portion of the patch, Grade H/Score 3=Small petechial erosions and/or scabs. Superficial irritation scores were only provided if there was a dermal response score >0. Full range was 0-10. Lower score indicates better tolerability.
Time Frame At Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent to treat (ITT, N=36) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.
Arm/Group Title Test Product Negative Control
Hide Arm/Group Description:
This arm included data from all the test sites were test product was applied.
This arm included data from all the test sites were negative control was applied.
Overall Number of Participants Analyzed 36 36
Mean (Standard Deviation)
Unit of Measure: Score on scale
0  (0) 0  (0)
2.Primary Outcome
Title Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 4
Hide Description A trained assessor assessed all patch sites. The following scores were used to express the response observed at the 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: Grade A/Score 0=Slight glazed appearance, Grade B/Score 1=Marked glazing, Grade C/Score 2=Glazing with peeling and cracking, Grade F/Score 3=Glazing with fissures, Grade G/Score 3=Film of dried serous exudate covering all or portion of the patch, Grade H/Score 3=Small petechial erosions and/or scabs. Superficial irritation scores were only provided if there was a dermal response score >0. Full range was 0-10. Lower score indicates better tolerability.
Time Frame At Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent to treat (ITT, N=36) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.
Arm/Group Title Test Product Negative Control
Hide Arm/Group Description:
This arm included data from all the test sites were test product was applied.
This arm included data from all the test sites were negative control was applied.
Overall Number of Participants Analyzed 36 36
Mean (Standard Deviation)
Unit of Measure: Score on scale
0  (0) 0  (0)
3.Primary Outcome
Title Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 5
Hide Description A trained assessor assessed all patch sites. The following scores were used to express the response observed at the 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: Grade A/Score 0=Slight glazed appearance, Grade B/Score 1=Marked glazing, Grade C/Score 2=Glazing with peeling and cracking, Grade F/Score 3=Glazing with fissures, Grade G/Score 3=Film of dried serous exudate covering all or portion of the patch, Grade H/Score 3=Small petechial erosions and/or scabs. Superficial irritation scores were only provided if there was a dermal response score >0. Full range was 0-10. Lower score indicates better tolerability.
Time Frame At Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT (N=36) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.
Arm/Group Title Test Product Negative Control
Hide Arm/Group Description:
This arm included data from all the test sites were test product was applied.
This arm included data from all the test sites were negative control was applied.
Overall Number of Participants Analyzed 36 36
Mean (Standard Deviation)
Unit of Measure: Score on scale
0  (0) 0  (0)
4.Primary Outcome
Title Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 8
Hide Description A trained assessor assessed all patch sites. The following scores were used to express the response observed at the 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: Grade A/Score 0=Slight glazed appearance, Grade B/Score 1=Marked glazing, Grade C/Score 2=Glazing with peeling and cracking, Grade F/Score 3=Glazing with fissures, Grade G/Score 3=Film of dried serous exudate covering all or portion of the patch, Grade H/Score 3=Small petechial erosions and/or scabs. Superficial irritation scores were only provided if there was a dermal response score >0. Full range was 0-10. Lower score indicates better tolerability.
Time Frame At Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT (N=36) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.
Arm/Group Title Test Product Negative Control
Hide Arm/Group Description:
This arm included data from all the test sites were test product was applied.
This arm included data from all the test sites were negative control was applied.
Overall Number of Participants Analyzed 36 36
Mean (Standard Deviation)
Unit of Measure: Score on scale
0  (0) 0  (0)
5.Primary Outcome
Title Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 9
Hide Description A trained assessor assessed all patch sites. The following scores were used to express the response observed at the 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: Grade A/Score 0=Slight glazed appearance, Grade B/Score 1=Marked glazing, Grade C/Score 2=Glazing with peeling and cracking, Grade F/Score 3=Glazing with fissures, Grade G/Score 3=Film of dried serous exudate covering all or portion of the patch, Grade H/Score 3=Small petechial erosions and/or scabs. Superficial irritation scores were only provided if there was a dermal response score >0. Full range was 0-10. Lower score indicates better tolerability.
Time Frame At Day 9
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT (N=36) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.
Arm/Group Title Test Product Negative Control
Hide Arm/Group Description:
This arm included data from all the test sites were test product was applied.
This arm included data from all the test sites were negative control was applied.
Overall Number of Participants Analyzed 36 36
Mean (Standard Deviation)
Unit of Measure: Score on scale
0  (0) 0  (0)
6.Primary Outcome
Title Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 11
Hide Description A trained assessor assessed all patch sites. The following scores were used to express the response observed at the 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: Grade A/Score 0=Slight glazed appearance, Grade B/Score 1=Marked glazing, Grade C/Score 2=Glazing with peeling and cracking, Grade F/Score 3=Glazing with fissures, Grade G/Score 3=Film of dried serous exudate covering all or portion of the patch, Grade H/Score 3=Small petechial erosions and/or scabs. Superficial irritation scores were only provided if there was a dermal response score >0. Full range was 0-10. Lower score indicates better tolerability.
Time Frame At Day 11
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT (N=36) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.
Arm/Group Title Test Product Negative Control
Hide Arm/Group Description:
This arm included data from all the test sites were test product was applied.
This arm included data from all the test sites were negative control was applied.
Overall Number of Participants Analyzed 36 36
Mean (Standard Deviation)
Unit of Measure: Score on scale
0  (0) 0  (0)
7.Primary Outcome
Title Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 12
Hide Description A trained assessor assessed all patch sites. The following scores were used to express the response observed at the 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: Grade A/Score 0=Slight glazed appearance, Grade B/Score 1=Marked glazing, Grade C/Score 2=Glazing with peeling and cracking, Grade F/Score 3=Glazing with fissures, Grade G/Score 3=Film of dried serous exudate covering all or portion of the patch, Grade H/Score 3=Small petechial erosions and/or scabs. Superficial irritation scores were only provided if there was a dermal response score >0. Full range was 0-10. Lower score indicates better tolerability.
Time Frame At Day 12
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT (N=36) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.
Arm/Group Title Test Product Negative Control
Hide Arm/Group Description:
This arm included data from all the test sites were test product was applied.
This arm included data from all the test sites were negative control was applied.
Overall Number of Participants Analyzed 36 36
Mean (Standard Deviation)
Unit of Measure: Score on scale
0  (0) 0  (0)
8.Primary Outcome
Title Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 15
Hide Description A trained assessor assessed all patch sites. The following scores were used to express the response observed at the 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: Grade A/Score 0=Slight glazed appearance, Grade B/Score 1=Marked glazing, Grade C/Score 2=Glazing with peeling and cracking, Grade F/Score 3=Glazing with fissures, Grade G/Score 3=Film of dried serous exudate covering all or portion of the patch, Grade H/Score 3=Small petechial erosions and/or scabs. Superficial irritation scores were only provided if there was a dermal response score >0. Full range was 0-10. Lower score indicates better tolerability.
Time Frame At Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT (N=36) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.
Arm/Group Title Test Product Negative Control
Hide Arm/Group Description:
This arm included data from all the test sites were test product was applied.
This arm included data from all the test sites were negative control was applied.
Overall Number of Participants Analyzed 36 36
Mean (Standard Deviation)
Unit of Measure: Score on scale
0  (0) 0  (0)
9.Primary Outcome
Title Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 16
Hide Description A trained assessor assessed all patch sites. The following scores were used to express the response observed at the 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: Grade A/Score 0=Slight glazed appearance, Grade B/Score 1=Marked glazing, Grade C/Score 2=Glazing with peeling and cracking, Grade F/Score 3=Glazing with fissures, Grade G/Score 3=Film of dried serous exudate covering all or portion of the patch, Grade H/Score 3=Small petechial erosions and/or scabs. Superficial irritation scores were only provided if there was a dermal response score >0. Full range was 0-10. Lower score indicates better tolerability.
Time Frame At Day 16
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT (N=36) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.
Arm/Group Title Test Product Negative Control
Hide Arm/Group Description:
This arm included data from all the test sites were test product was applied.
This arm included data from all the test sites were negative control was applied.
Overall Number of Participants Analyzed 36 36
Mean (Standard Deviation)
Unit of Measure: Score on scale
0  (0) 0  (0)
10.Primary Outcome
Title Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 18
Hide Description A trained assessor assessed all patch sites. The following scores were used to express the response observed at the 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: Grade A/Score 0=Slight glazed appearance, Grade B/Score 1=Marked glazing, Grade C/Score 2=Glazing with peeling and cracking, Grade F/Score 3=Glazing with fissures, Grade G/Score 3=Film of dried serous exudate covering all or portion of the patch, Grade H/Score 3=Small petechial erosions and/or scabs. Superficial irritation scores were only provided if there was a dermal response score >0. Full range was 0-10. Lower score indicates better tolerability.
Time Frame At Day 18
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT (N=36) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.
Arm/Group Title Test Product Negative Control
Hide Arm/Group Description:
This arm included data from all the test sites were test product was applied.
This arm included data from all the test sites were negative control was applied.
Overall Number of Participants Analyzed 36 36
Mean (Standard Deviation)
Unit of Measure: Score on scale
0  (0) 0  (0)
11.Primary Outcome
Title Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 19
Hide Description A trained assessor assessed all patch sites. The following scores were used to express the response observed at the 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: Grade A/Score 0=Slight glazed appearance, Grade B/Score 1=Marked glazing, Grade C/Score 2=Glazing with peeling and cracking, Grade F/Score 3=Glazing with fissures, Grade G/Score 3=Film of dried serous exudate covering all or portion of the patch, Grade H/Score 3=Small petechial erosions and/or scabs. Superficial irritation scores were only provided if there was a dermal response score >0. Full range was 0-10. Lower score indicates better tolerability.
Time Frame At Day 19
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT (N=36) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.
Arm/Group Title Test Product Negative Control
Hide Arm/Group Description:
This arm included data from all the test sites were test product was applied.
This arm included data from all the test sites were negative control was applied.
Overall Number of Participants Analyzed 36 36
Mean (Standard Deviation)
Unit of Measure: Score on scale
0  (0) 0  (0)
12.Primary Outcome
Title Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Challenge Phase At Week 6 (After 30 Minutes [Maximum 1 Hour], Post Patch Removal)
Hide Description A trained assessor assessed all patch sites. The following scores were used to express the response observed at the 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: Grade A/Score 0=Slight glazed appearance, Grade B/Score 1=Marked glazing, Grade C/Score 2=Glazing with peeling and cracking, Grade F/Score 3=Glazing with fissures, Grade G/Score 3=Film of dried serous exudate covering all or portion of the patch, Grade H/Score 3=Small petechial erosions and/or scabs. Superficial irritation scores were only provided if there was a dermal response score >0. Full range was 0-10. Lower score indicates better tolerability.
Time Frame At Week 6 (after 30 minutes [maximum 1 hour], post patch removal)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT (N=36) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.
Arm/Group Title Test Product Negative Control
Hide Arm/Group Description:
This arm included data from all the test sites were test product was applied.
This arm included data from all the test sites were negative control was applied.
Overall Number of Participants Analyzed 36 36
Mean (Standard Deviation)
Unit of Measure: Score on scale
0  (0) 0  (0)
13.Primary Outcome
Title Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Challenge Phase At Week 6 24 (±2) Hours Post Patch Removal
Hide Description A trained assessor assessed all patch sites. The following scores were used to express the response observed at the 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: Grade A/Score 0=Slight glazed appearance, Grade B/Score 1=Marked glazing, Grade C/Score 2=Glazing with peeling and cracking, Grade F/Score 3=Glazing with fissures, Grade G/Score 3=Film of dried serous exudate covering all or portion of the patch, Grade H/Score 3=Small petechial erosions and/or scabs. Superficial irritation scores were only provided if there was a dermal response score >0. Full range was 0-10. Lower score indicates better tolerability.
Time Frame At Week 6 24 (±2) hours post patch removal
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT (N=36) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.
Arm/Group Title Test Product Negative Control
Hide Arm/Group Description:
This arm included data from all the test sites were test product was applied.
This arm included data from all the test sites were negative control was applied.
Overall Number of Participants Analyzed 36 36
Mean (Standard Deviation)
Unit of Measure: Score on scale
0  (0) 0  (0)
14.Primary Outcome
Title Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Challenge Phase at Week 6 48 (±2) Hours, Post Patch Removal
Hide Description A trained assessor assessed all patch sites. The following scores were used to express the response observed at the 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: Grade A/Score 0=Slight glazed appearance, Grade B/Score 1=Marked glazing, Grade C/Score 2=Glazing with peeling and cracking, Grade F/Score 3=Glazing with fissures, Grade G/Score 3=Film of dried serous exudate covering all or portion of the patch, Grade H/Score 3=Small petechial erosions and/or scabs. Superficial irritation scores were only provided if there was a dermal response score >0. Full range was 0-10. Lower score indicates better tolerability.
Time Frame At Week 6, 48 (±2) hours, post patch removal
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT (N=36) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.
Arm/Group Title Test Product Negative Control
Hide Arm/Group Description:
This arm included data from all the test sites were test product was applied.
This arm included data from all the test sites were negative control was applied.
Overall Number of Participants Analyzed 36 36
Mean (Standard Deviation)
Unit of Measure: Score on scale
0  (0) 0  (0)
Time Frame Approximately 45 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Participants
Hide Arm/Group Description The safety population (N=36). The Safety population included all participants who received any study product.
All-Cause Mortality
All Participants
Affected / at Risk (%)
Total   0/36 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
All Participants
Affected / at Risk (%)
Total   0/36 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
All Participants
Affected / at Risk (%)
Total   2/36 (5.56%) 
Infections and infestations   
INFLUENZA   1/36 (2.78%) 
RHINITIS   1/36 (2.78%) 
Musculoskeletal and connective tissue disorders   
MYALGIA   1/36 (2.78%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03183518     History of Changes
Other Study ID Numbers: 207587
First Submitted: May 17, 2017
First Posted: June 12, 2017
Results First Submitted: May 1, 2018
Results First Posted: February 15, 2019
Last Update Posted: February 15, 2019