Trial Outcomes & Findings for To Assess the Photosensitisation and Photoallergy Potential of a Cosmetic Facial Product in Healthy Participants (NCT NCT03183518)
NCT ID: NCT03183518
Last Updated: 2019-02-15
Results Overview
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.
COMPLETED
NA
48 participants
At Day 2
2019-02-15
Participant Flow
All participants were enrolled at one center in Brazil.
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.
Participant milestones
| Measure |
All Participants
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).
|
|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
Test Product
|
36
|
|
Overall Study
Negative Control
|
36
|
|
Overall Study
COMPLETED
|
33
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
All Participants
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).
|
|---|---|
|
Overall Study
Other (Not specified)
|
2
|
|
Overall Study
Other (Withdrawal of consent)
|
1
|
Baseline Characteristics
To Assess the Photosensitisation and Photoallergy Potential of a Cosmetic Facial Product in Healthy Participants
Baseline characteristics by cohort
| Measure |
All Participants
n=36 Participants
Baseline population includes safety population (N=36). The Safety population included all participants who received any study product.
|
|---|---|
|
Age, Continuous
|
40.6 Years
STANDARD_DEVIATION 11.40 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Day 2Population: 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.
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.
Outcome measures
| Measure |
Test Product
n=36 Participants
This arm included data from all the test sites were test product was applied.
|
Negative Control
n=36 Participants
This arm included data from all the test sites were negative control was applied.
|
|---|---|---|
|
Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 2
|
0 Score on scale
Standard Deviation 0
|
0 Score on scale
Standard Deviation 0
|
PRIMARY outcome
Timeframe: At Day 4Population: 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.
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.
Outcome measures
| Measure |
Test Product
n=36 Participants
This arm included data from all the test sites were test product was applied.
|
Negative Control
n=36 Participants
This arm included data from all the test sites were negative control was applied.
|
|---|---|---|
|
Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 4
|
0 Score on scale
Standard Deviation 0
|
0 Score on scale
Standard Deviation 0
|
PRIMARY outcome
Timeframe: At Day 5Population: 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.
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.
Outcome measures
| Measure |
Test Product
n=36 Participants
This arm included data from all the test sites were test product was applied.
|
Negative Control
n=36 Participants
This arm included data from all the test sites were negative control was applied.
|
|---|---|---|
|
Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 5
|
0 Score on scale
Standard Deviation 0
|
0 Score on scale
Standard Deviation 0
|
PRIMARY outcome
Timeframe: At Day 8Population: 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.
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.
Outcome measures
| Measure |
Test Product
n=36 Participants
This arm included data from all the test sites were test product was applied.
|
Negative Control
n=36 Participants
This arm included data from all the test sites were negative control was applied.
|
|---|---|---|
|
Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 8
|
0 Score on scale
Standard Deviation 0
|
0 Score on scale
Standard Deviation 0
|
PRIMARY outcome
Timeframe: At Day 9Population: 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.
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.
Outcome measures
| Measure |
Test Product
n=36 Participants
This arm included data from all the test sites were test product was applied.
|
Negative Control
n=36 Participants
This arm included data from all the test sites were negative control was applied.
|
|---|---|---|
|
Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 9
|
0 Score on scale
Standard Deviation 0
|
0 Score on scale
Standard Deviation 0
|
PRIMARY outcome
Timeframe: At Day 11Population: 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.
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.
Outcome measures
| Measure |
Test Product
n=36 Participants
This arm included data from all the test sites were test product was applied.
|
Negative Control
n=36 Participants
This arm included data from all the test sites were negative control was applied.
|
|---|---|---|
|
Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 11
|
0 Score on scale
Standard Deviation 0
|
0 Score on scale
Standard Deviation 0
|
PRIMARY outcome
Timeframe: At Day 12Population: 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.
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.
Outcome measures
| Measure |
Test Product
n=36 Participants
This arm included data from all the test sites were test product was applied.
|
Negative Control
n=36 Participants
This arm included data from all the test sites were negative control was applied.
|
|---|---|---|
|
Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 12
|
0 Score on scale
Standard Deviation 0
|
0 Score on scale
Standard Deviation 0
|
PRIMARY outcome
Timeframe: At Day 15Population: 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.
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.
Outcome measures
| Measure |
Test Product
n=36 Participants
This arm included data from all the test sites were test product was applied.
|
Negative Control
n=36 Participants
This arm included data from all the test sites were negative control was applied.
|
|---|---|---|
|
Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 15
|
0 Score on scale
Standard Deviation 0
|
0 Score on scale
Standard Deviation 0
|
PRIMARY outcome
Timeframe: At Day 16Population: 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.
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.
Outcome measures
| Measure |
Test Product
n=36 Participants
This arm included data from all the test sites were test product was applied.
|
Negative Control
n=36 Participants
This arm included data from all the test sites were negative control was applied.
|
|---|---|---|
|
Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 16
|
0 Score on scale
Standard Deviation 0
|
0 Score on scale
Standard Deviation 0
|
PRIMARY outcome
Timeframe: At Day 18Population: 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.
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.
Outcome measures
| Measure |
Test Product
n=36 Participants
This arm included data from all the test sites were test product was applied.
|
Negative Control
n=36 Participants
This arm included data from all the test sites were negative control was applied.
|
|---|---|---|
|
Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 18
|
0 Score on scale
Standard Deviation 0
|
0 Score on scale
Standard Deviation 0
|
PRIMARY outcome
Timeframe: At Day 19Population: 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.
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.
Outcome measures
| Measure |
Test Product
n=36 Participants
This arm included data from all the test sites were test product was applied.
|
Negative Control
n=36 Participants
This arm included data from all the test sites were negative control was applied.
|
|---|---|---|
|
Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 19
|
0 Score on scale
Standard Deviation 0
|
0 Score on scale
Standard Deviation 0
|
PRIMARY outcome
Timeframe: At Week 6 (after 30 minutes [maximum 1 hour], post patch removal)Population: 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.
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.
Outcome measures
| Measure |
Test Product
n=36 Participants
This arm included data from all the test sites were test product was applied.
|
Negative Control
n=36 Participants
This arm included data from all the test sites were negative control was applied.
|
|---|---|---|
|
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)
|
0 Score on scale
Standard Deviation 0
|
0 Score on scale
Standard Deviation 0
|
PRIMARY outcome
Timeframe: At Week 6 24 (±2) hours post patch removalPopulation: 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.
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.
Outcome measures
| Measure |
Test Product
n=36 Participants
This arm included data from all the test sites were test product was applied.
|
Negative Control
n=36 Participants
This arm included data from all the test sites were negative control was applied.
|
|---|---|---|
|
Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Challenge Phase At Week 6 24 (±2) Hours Post Patch Removal
|
0 Score on scale
Standard Deviation 0
|
0 Score on scale
Standard Deviation 0
|
PRIMARY outcome
Timeframe: At Week 6, 48 (±2) hours, post patch removalPopulation: 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.
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.
Outcome measures
| Measure |
Test Product
n=36 Participants
This arm included data from all the test sites were test product was applied.
|
Negative Control
n=36 Participants
This arm included data from all the test sites were negative control was applied.
|
|---|---|---|
|
Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Challenge Phase at Week 6 48 (±2) Hours, Post Patch Removal
|
0 Score on scale
Standard Deviation 0
|
0 Score on scale
Standard Deviation 0
|
Adverse Events
All Participants
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All Participants
n=36 participants at risk
The safety population (N=36). The Safety population included all participants who received any study product.
|
|---|---|
|
Infections and infestations
INFLUENZA
|
2.8%
1/36 • Approximately 45 days
|
|
Infections and infestations
RHINITIS
|
2.8%
1/36 • Approximately 45 days
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
2.8%
1/36 • Approximately 45 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER