Skin Care
Conditions
Brief summary
To evaluate the skin irritation and sensitization potential of a cosmetic facial product, under exaggerated conditions of use with controlled product application and under supervision of a dermatologist.
Detailed description
In this three-phase phototoxicity-photosensitisation (PT-PA) study, the test material and a positive control are applied under a semi-occlusive patch to the upper back of each subject. The first phase of the study is an Induction Phase; a controlled amount of each product is applied under a semi-occlusive patch. The patch will remain on the skin for 24 (±2) hours during this phase. Following patch removal the patch site will be exposed to ultraviolet - A (UVA) radiation and re-assessed 24 hours later prior to re-application of another semi-occlusive patch (with both the products) to the same site. The Induction phase will last 3 weeks. After a subject completes the Induction Phase they will enter a Rest Phase of 2 weeks duration, during which no patches will be applied. After the Rest Phase, subjects will return to the clinical site for the Challenge Phase. In the Challenge phase two test patches will be applied to virgin skin areas on each subjects' upper back for 24 hours. Following removal of both patches, one of the Challenge patch test sites will be exposed to UVA radiation. Both Challenge patch test sites will be assessed up until 72 (±2) hours later.
Interventions
Each participant will have the test product applied topically via semi occlusive patch, on-site by a technician.
Each participant will have the reference product applied topically via semi occlusive patch, on-site by a technician.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form. * Aged between 18 and 65 years inclusive. * Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon physical examination. * Healthy, intact skin at the proposed application site; dorsum (scapular region). * Clinical assessment for eligibility (at Visit 1 and Visit 2 - if not combined) by a dermatologist to ensure subject is free of clinically relevant dermatological conditions. * Fitzpatrick phototype II to IV. * Agreement to comply with the procedures and requirements of the study and to attend the scheduled assessment visits.
Exclusion criteria
* Women who are known to be pregnant or who are intending to become pregnant over the duration of the study. * Women who are breast-feeding. * Any history of significant dermatological diseases or conditions or medical conditions known to alter skin appearance or physiologic response (e.g. diabetes) which could, in the opinion of the Investigator, preclude topical application of the investigational products and/or interfere with the evaluation of the test site reaction. * Presence of open sores, pimples, or cysts at the application site. * Active dermatosis (local or disseminated) that might interfere with the results of the study. * Considered immune compromised. * History of diseases aggravated or triggered by ultraviolet radiation. * Participants with dermatographism. * Currently using any medication which in the opinion of the investigator, may affect the evaluation of the study product, or place the subject at undue risk. * Use of the following topical or systemic medications: immunosuppressants, antihistamines, non-hormonal anti-inflammatory drugs, and corticosteroids up to 2 weeks before screening visit. * Oral or topical treatment with vitamin A acid and/or its derivatives up to 1 month before the screening visit. * Intention of being vaccinated during the study period or has been vaccinated within 3 weeks of the screening visit. * Currently receiving allergy injections, or received an allergy injection within 7 days prior to Visit 1, or expects to begin injections during study participation. * Previous history of atopy, allergic reactions, irritation or intense discomfort feelings to topical-use products, cosmetics or medication. * Study subjects with a history of allergy to the study material/product, hypoallergenic tape, or to the cotton patches. * History of sensitisation in a previous patch study. * History of abnormal reaction to sun exposure. * Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit. * Previous participation in this study. * Recent history (within the last 5 years) of alcohol or other substance abuse. * Intense sunlight exposure or sun tanning sessions up to 30 days before the Screening evaluation. * Intention of bathing (in the sea or pool), sauna, water sports, or activities that lead to intense sweating. * Any Subject who, in the judgment of the Investigator, should not participate in the study. * Any skin marks on the test site that might interfere with the evaluation of possible skin reactions (e.g. pigmentation disorders, vascular malformations, scars, tattoos, excessive hair, numerous freckles). * Prisoner or involuntary incarcerated subject. * Subject from an indigenous tribe. * An employee of the sponsor or the study site or members of their immediate family.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 2 | At Day 2 | 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. |
| Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 4 | At Day 4 | 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. |
| Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 5 | At Day 5 | 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. |
| Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 8 | At Day 8 | 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. |
| Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 9 | At Day 9 | 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. |
| Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 11 | At Day 11 | 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. |
| Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 12 | At Day 12 | 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. |
| Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 15 | At Day 15 | 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. |
| Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 16 | At Day 16 | 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. |
| Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 18 | At Day 18 | 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. |
| Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 19 | At Day 19 | 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. |
| 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) | At Week 6 (after 30 minutes [maximum 1 hour], post patch removal) | 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. |
| Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Challenge Phase At Week 6 24 (±2) Hours Post Patch Removal | At Week 6 24 (±2) hours post patch removal | 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. |
| Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Challenge Phase at Week 6 48 (±2) Hours, Post Patch Removal | At Week 6, 48 (±2) hours, post patch removal | 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. |
Countries
Brazil
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Baseline population includes safety population (N=36). The Safety population included all participants who received any study product. | 36 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Other (Not specified) | 2 |
| Overall Study | Other (Withdrawal of consent) | 1 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 40.6 Years STANDARD_DEVIATION 11.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 35 Participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 36 |
| other Total, other adverse events | 2 / 36 |
| serious Total, serious adverse events | 0 / 36 |
Outcome results
Primary
Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Challenge Phase At Week 6 24 (±2) Hours Post Patch Removal
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Product | 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 |
| Negative Control | 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 |
Primary
Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Challenge Phase at Week 6 48 (±2) Hours, Post Patch Removal
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Product | 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 |
| Negative Control | 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 |
Primary
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)
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)
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Product | 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 |
| Negative Control | 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 |
Primary
Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 11
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Product | Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 11 | 0 Score on scale | Standard Deviation 0 |
| Negative Control | Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 11 | 0 Score on scale | Standard Deviation 0 |
Primary
Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 12
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Product | Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 12 | 0 Score on scale | Standard Deviation 0 |
| Negative Control | Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 12 | 0 Score on scale | Standard Deviation 0 |
Primary
Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 15
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Product | Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 15 | 0 Score on scale | Standard Deviation 0 |
| Negative Control | Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 15 | 0 Score on scale | Standard Deviation 0 |
Primary
Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 16
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Product | Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 16 | 0 Score on scale | Standard Deviation 0 |
| Negative Control | Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 16 | 0 Score on scale | Standard Deviation 0 |
Primary
Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 18
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Product | Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 18 | 0 Score on scale | Standard Deviation 0 |
| Negative Control | Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 18 | 0 Score on scale | Standard Deviation 0 |
Primary
Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 19
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Product | Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 19 | 0 Score on scale | Standard Deviation 0 |
| Negative Control | Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 19 | 0 Score on scale | Standard Deviation 0 |
Primary
Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 2
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Product | Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 2 | 0 Score on scale | Standard Deviation 0 |
| Negative Control | Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 2 | 0 Score on scale | Standard Deviation 0 |
Primary
Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 4
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Product | Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 4 | 0 Score on scale | Standard Deviation 0 |
| Negative Control | Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 4 | 0 Score on scale | Standard Deviation 0 |
Primary
Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 5
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Product | Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 5 | 0 Score on scale | Standard Deviation 0 |
| Negative Control | Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 5 | 0 Score on scale | Standard Deviation 0 |
Primary
Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 8
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Product | Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 8 | 0 Score on scale | Standard Deviation 0 |
| Negative Control | Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 8 | 0 Score on scale | Standard Deviation 0 |
Primary
Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 9
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Product | Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 9 | 0 Score on scale | Standard Deviation 0 |
| Negative Control | Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 9 | 0 Score on scale | Standard Deviation 0 |