Trial Outcomes & Findings for To Assess the Cutaneous Irritation and Sensitization Potential of a Cosmetic Facial Product Using a Human Repeat Insult Patch Test (HRIPT) in Healthy Participants (NCT NCT03175562)

NCT ID: NCT03175562

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 272 participants
• Primary outcome timeframe: At Day 3
• Results posted on: 2019-02-15

Participant Flow

All participants were enrolled at one center in Brazil.

A total of 294 participants were screened,out of which 240 participants were randomized and 54 participants were not randomized. Out of 54 participants, 22 participants did not meet study criteria, 5 participants were lost to follow-up, 26 participants withdrew their consent, 1 participant was not randomized for other reasons (not specified).

Participant milestones

Measure	All Participants Included all participants who were randomized to receive the study treatment. In this study, the test product and the negative control (saline solution) were randomly applied to 2 different cells in a single semi-occlusive patch that was applied on a subject's dorsum.
Overall Study STARTED	240
Overall Study Test Product	240
Overall Study Negative Control	240
Overall Study COMPLETED	224
Overall Study NOT COMPLETED	16

Reasons for withdrawal

Measure	All Participants Included all participants who were randomized to receive the study treatment. In this study, the test product and the negative control (saline solution) were randomly applied to 2 different cells in a single semi-occlusive patch that was applied on a subject's dorsum.
Overall Study Adverse Event	1
Overall Study Lost to Follow-up	3
Overall Study Withdrawal by Subject	7
Overall Study Other (Not Specified)	5

Baseline Characteristics

To Assess the Cutaneous Irritation and Sensitization Potential of a Cosmetic Facial Product Using a Human Repeat Insult Patch Test (HRIPT) in Healthy Participants

Baseline characteristics by cohort

Measure	Overall Participants n=240 Participants All the participants who received any application of study products were included for baseline evaluation
Age, Continuous	41.2 Years STANDARD_DEVIATION 12.44 • n=5 Participants
Sex: Female, Male Female	196 Participants n=5 Participants
Sex: Female, Male Male	44 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 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	5 Participants n=5 Participants
Race (NIH/OMB) White	234 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 3

Population: The Intent to treat (ITT, N=238) 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=238 Participants This arm included data from all the test sites were test product was applied.	Reference Product n=238 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 3	0 Score on scale Standard Deviation 0	0 Score on scale Standard Deviation 0

PRIMARY outcome

Timeframe: At Day 5

Population: The ITT (N=238) 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=238 Participants This arm included data from all the test sites were test product was applied.	Reference Product n=238 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 8

Population: The ITT (N=238) 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=238 Participants This arm included data from all the test sites were test product was applied.	Reference Product n=238 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 10

Population: The ITT (N=238) 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=238 Participants This arm included data from all the test sites were test product was applied.	Reference Product n=238 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 10	0 Score on scale Standard Deviation 0	0 Score on scale Standard Deviation 0

PRIMARY outcome

Timeframe: At Day 12

Population: The ITT (N=238) 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=238 Participants This arm included data from all the test sites were test product was applied.	Reference Product n=238 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 Error 0	0 Score on scale Standard Error 0

PRIMARY outcome

Timeframe: At Day 15

Population: The ITT (N=238) 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=238 Participants This arm included data from all the test sites were test product was applied.	Reference Product n=238 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 17

Population: The ITT (N=238) 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=238 Participants This arm included data from all the test sites were test product was applied.	Reference Product n=238 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 17	0 Score on scale Standard Deviation 0	0 Score on scale Standard Deviation 0

PRIMARY outcome

Timeframe: At Day 19

Population: The ITT (N=238) 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=238 Participants This arm included data from all the test sites were test product was applied.	Reference Product n=238 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=238) 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=238 Participants This arm included data from all the test sites were test product was applied.	Reference Product n=238 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 after 24 (±2) hours post patch removal

Population: The ITT (N=238) 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=238 Participants This arm included data from all the test sites were test product was applied.	Reference Product n=238 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 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 after 48 (±2) hours post patch removal

Population: The ITT (N=238) 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=238 Participants This arm included data from all the test sites were test product was applied.	Reference Product n=238 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 6 Week 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 events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	All Participants n=240 participants at risk Safety population (N=240), the Safety population included all participants who received any application of the study products.
Infections and infestations INFLUENZA	1.2% 3/240 • Approximately 45 days
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.42% 1/240 • Approximately 45 days
Musculoskeletal and connective tissue disorders MYALGIA	0.42% 1/240 • Approximately 45 days
Infections and infestations TONSILLITIS BACTERIAL	0.42% 1/240 • Approximately 45 days
Gastrointestinal disorders VOMITING	0.42% 1/240 • Approximately 45 days

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: GSKClinicalSupportHD@gsk.com

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