Atopic Dermatitis
Conditions
Brief summary
To establish the bioequivalence between test drug, Pimecrolimus Cream, 1% with that of reference listed drug, Elidel® (pimecrolimus) Cream 1%, in the treatment of mild to moderate Atopic Dermatitis. To establish superiority of each active treatment over the placebo.
Interventions
DRUGPlacebo Cream
Sponsors
DPT Laboratories, Ltd.
Mylan Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Non-immuno compromised male or female aged 8 years and older * Clinical diagnosis of mild to moderate Atopic Dermatitis (AD) * Failed to respond adequately to other topical prescription treatments for AD, or for whom those treatments are not advisable. * A diagnosis of AD for at least 3 months * An Investigator's Global Assessment (IGA) of disease severity of mild or moderate at baseline (score of 2 or 3) * Affected area of AD involvement at least 5% body surface area (BSA) * Treated with a bland emollient for at least 7 days
Exclusion criteria
* Females who are pregnant, breast feeding, or who wish to become pregnant during the study period * Active cutaneous bacterial or viral infection in any treatment area at baseline (e.g., clinically infected atopic dermatitis, impetigo). * Sunburn, extensive scarring or pigmented lesion(s) in any treatment area at baseline, which would interfere with evaluations * History or presence of confounding skin conditions, e.g., psoriasis, rosacea, erythroderma, ichthyosis, or scabies. * History or presence of Netherton's Syndrome, immunological deficiencies or diseases, HIV, diabetes, malignancy, serious active or recurrent infection, clinically significant severe renal insufficiency or severe hepatic disorders * Concurrent disease or treatment likely to interfere with the study treatment or evaluations * Known allergy or hypersensitivity to pimecrolimus or any other component of the drug products * Not willing to minimize or avoid natural and artificial sunlight exposure during treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Modified Intent to Treat Subjects With Success on Investigator's Global Assessment of Disease Severity (Success Being a Score of Clear [0] or Almost Clear [1]) | Day 15 | Investigator's Global Assessment of Disease Severity Scale: Clear (0) Minor residual discoloration, no erythema or induration/papulation, no oozing/crusting; Almost Clear (1) Trace faint pink erythema with almost no induration/papulation and no oozing/crusting; Mild disease (1) Faint pink erythema with mild induration/papulation and no oozing/crusting; Moderate disease (3) Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting; Severe disease (4) Deep/bright red erythema with severe induration/papulation with oozing/crusting |
| Proportion of Per Protocol Subjects With Success on Investigator's Global Assessment of Disease Severity (Success Being a Score of Clear [0] or Almost Clear [1]) | Day 15 | Investigator's Global Assessment of Disease Severity Scale: Clear (0) Minor residual discoloration, no erythema or induration/papulation, no oozing/crusting; Almost Clear (1) Trace faint pink erythema with almost no induration/papulation and no oozing/crusting; Mild disease (1) Faint pink erythema with mild induration/papulation and no oozing/crusting; Moderate disease (3) Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting; Severe disease (4) Deep/bright red erythema with severe induration/papulation with oozing/crusting |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Severity of Four Individual Signs and Symptoms | Day 15 | Erythema, induration/papulation, lichenification and pruritus |
| Evaluation of Application Site Reactions | Day 15 | Dryness, burning/stinging, erosion, edema, and pain |
Countries
Dominican Republic, Honduras, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Test Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days
Pimecrolimus Cream, 1% | 215 |
| Reference Standard Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days
Pimecrolimus Cream, 1% | 214 |
| Placebo Placebo cream, topical, thin layer applied to all affected skin areas twice daily for 14 days
Placebo Cream | 220 |
| Total | 649 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 2 |
| Overall Study | Lost to Follow-up | 3 | 3 | 3 |
| Overall Study | Protocol Violation | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 1 |
| Overall Study | Worsening signs/symptoms | 2 | 1 | 2 |
Baseline characteristics
| Characteristic | Test | Total | Placebo | Reference Standard |
|---|---|---|---|---|
| Age, Continuous | 37.0 years STANDARD_DEVIATION 20.2 | 35.4 years STANDARD_DEVIATION 20.3 | 34.9 years STANDARD_DEVIATION 21.6 | 34.2 years STANDARD_DEVIATION 18.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 127 Participants | 378 Participants | 125 Participants | 126 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 88 Participants | 271 Participants | 95 Participants | 88 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Investigator's Global Assessement of Severity Mild | 90 Participants | 295 Participants | 109 Participants | 96 Participants |
| Investigator's Global Assessement of Severity Moderate | 125 Participants | 354 Participants | 111 Participants | 118 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 3 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 98 Participants | 284 Participants | 93 Participants | 93 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 6 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 5 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 115 Participants | 350 Participants | 117 Participants | 118 Participants |
| Sex: Female, Male Female | 127 Participants | 404 Participants | 133 Participants | 144 Participants |
| Sex: Female, Male Male | 88 Participants | 245 Participants | 87 Participants | 70 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 215 | 0 / 214 | 0 / 220 |
| other Total, other adverse events | 0 / 215 | 0 / 214 | 0 / 220 |
| serious Total, serious adverse events | 0 / 215 | 0 / 214 | 0 / 220 |
Outcome results
Primary
Proportion of Modified Intent to Treat Subjects With Success on Investigator's Global Assessment of Disease Severity (Success Being a Score of Clear [0] or Almost Clear [1])
Investigator's Global Assessment of Disease Severity Scale: Clear (0) Minor residual discoloration, no erythema or induration/papulation, no oozing/crusting; Almost Clear (1) Trace faint pink erythema with almost no induration/papulation and no oozing/crusting; Mild disease (1) Faint pink erythema with mild induration/papulation and no oozing/crusting; Moderate disease (3) Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting; Severe disease (4) Deep/bright red erythema with severe induration/papulation with oozing/crusting
Time frame: Day 15
Population: Modified ITT (Intent-to-treat) sample
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Test | Proportion of Modified Intent to Treat Subjects With Success on Investigator's Global Assessment of Disease Severity (Success Being a Score of Clear [0] or Almost Clear [1]) | 108 Participants |
| Reference Standard | Proportion of Modified Intent to Treat Subjects With Success on Investigator's Global Assessment of Disease Severity (Success Being a Score of Clear [0] or Almost Clear [1]) | 115 Participants |
| Placebo | Proportion of Modified Intent to Treat Subjects With Success on Investigator's Global Assessment of Disease Severity (Success Being a Score of Clear [0] or Almost Clear [1]) | 98 Participants |
p-value: 0.0817Fisher Exact
p-value: 0.2874Fisher Exact
Primary
Proportion of Per Protocol Subjects With Success on Investigator's Global Assessment of Disease Severity (Success Being a Score of Clear [0] or Almost Clear [1])
Investigator's Global Assessment of Disease Severity Scale: Clear (0) Minor residual discoloration, no erythema or induration/papulation, no oozing/crusting; Almost Clear (1) Trace faint pink erythema with almost no induration/papulation and no oozing/crusting; Mild disease (1) Faint pink erythema with mild induration/papulation and no oozing/crusting; Moderate disease (3) Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting; Severe disease (4) Deep/bright red erythema with severe induration/papulation with oozing/crusting
Time frame: Day 15
Population: PP (per protocol) sample
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Test | Proportion of Per Protocol Subjects With Success on Investigator's Global Assessment of Disease Severity (Success Being a Score of Clear [0] or Almost Clear [1]) | 105 Participants |
| Reference Standard | Proportion of Per Protocol Subjects With Success on Investigator's Global Assessment of Disease Severity (Success Being a Score of Clear [0] or Almost Clear [1]) | 113 Participants |
| Placebo | Proportion of Per Protocol Subjects With Success on Investigator's Global Assessment of Disease Severity (Success Being a Score of Clear [0] or Almost Clear [1]) | 95 Participants |
90% CI: [-0.12, 0.06]
Secondary
Change in Severity of Four Individual Signs and Symptoms
Erythema, induration/papulation, lichenification and pruritus
Time frame: Day 15
Population: PP sample
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Test | Change in Severity of Four Individual Signs and Symptoms | Pruritus | 0 = No change | 42 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Head & Neck | -2 = Improve by 2 | 17 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Head & Neck | 0 = No change | 118 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Lower Limbs | 0 = No change | 126 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Head & Neck | -1 = Improve by 1 | 47 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Head & Neck | -1 = Improve by 1 | 59 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Erythema - Trunk | -1 = Improve by 1 | 56 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Head & Neck | 0 = No change | 131 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Head & Neck | -2 = Improve by 2 | 22 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Erythema - Head & Neck | -1 = Improve by 1 | 51 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Head & Neck | 1 = Worsen by 1 | 5 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Head & Neck | -3 = Improve by 3 | 1 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Erythema - Head & Neck | 3 = Worsen by 3 | 0 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Head & Neck | 2 = Worsen by 2 | 1 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Trunk | 3 = Worsen by 3 | 0 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Erythema - Trunk | -2 = Improve by 2 | 35 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Head & Neck | 3 = Worsen by 3 | 0 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Trunk | 2 = Worsen by 2 | 0 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Pruritus | -2 = Improve by 2 | 73 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Lower Limbs | -3 = Improve by 3 | 1 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Trunk | 1 = Worsen by 1 | 5 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Lower Limbs | 1 = Worsen by 1 | 6 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Lower Limbs | -2 = Improve by 2 | 24 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Trunk | 0 = No change | 103 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Erythema - Trunk | -3 = Improve by 3 | 1 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Lower Limbs | -1 = Improve by 1 | 71 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Trunk | -1 = Improve by 1 | 62 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Pruritus | 1 = Worsen by 1 | 4 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Lower Limbs | 0 = No change | 100 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Trunk | -2 = Improve by 2 | 31 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Lower Limbs | 2 = Worsen by 2 | 0 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Lower Limbs | 1 = Worsen by 1 | 5 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Trunk | -3 = Improve by 3 | 0 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Erythema - Upper Limbs | 3 = Worsen by 3 | 0 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Lower Limbs | 2 = Worsen by 2 | 0 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Upper Limbs | 3 = Worsen by 3 | 0 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Erythema - Head & Neck | -2 = Improve by 2 | 24 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Lower Limbs | 3 = Worsen by 3 | 0 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Upper Limbs | 2 = Worsen by 2 | 0 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Lower Limbs | 3 = Worsen by 3 | 0 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Upper Limbs | -3 = Improve by 3 | 0 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Upper Limbs | 1 = Worsen by 1 | 4 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Erythema - Upper Limbs | 2 = Worsen by 2 | 0 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Upper Limbs | -2 = Improve by 2 | 39 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Upper Limbs | 0 = No change | 75 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Erythema - Head & Neck | 1 = Worsen by 1 | 2 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Upper Limbs | -1 = Improve by 1 | 83 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Upper Limbs | -3 = Improve by 3 | 0 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Erythema - Upper Limbs | 1 = Worsen by 1 | 4 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Pruritus | 2 = Worsen by 2 | 2 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Upper Limbs | -2 = Improve by 2 | 29 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Erythema - Upper Limbs | 0 = No change | 71 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Erythema - Head & Neck | -3 = Improve by 3 | 2 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Upper Limbs | -1 = Improve by 1 | 72 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Erythema - Upper Limbs | -1 = Improve by 1 | 76 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Erythema - Head & Neck | 2 = Worsen by 2 | 1 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Upper Limbs | 0 = No change | 93 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Erythema - Upper Limbs | -2 = Improve by 2 | 49 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Pruritus | 3 = Worsen by 3 | 0 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Upper Limbs | 1 = Worsen by 1 | 7 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Erythema - Upper Limbs | -3 = Improve by 3 | 1 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Erythema - Trunk | 3 = Worsen by 3 | 0 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Upper Limbs | 2 = Worsen by 2 | 0 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Erythema - Lower Limbs | 3 = Worsen by 3 | 0 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Pruritus | -1 = Improve by 1 | 76 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Upper Limbs | 3 = Worsen by 3 | 0 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Erythema - Lower Limbs | 2 = Worsen by 2 | 0 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Lower Limbs | -3 = Improve by 3 | 2 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Trunk | -3 = Improve by 3 | 0 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Erythema - Lower Limbs | 1 = Worsen by 1 | 2 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Erythema - Trunk | 2 = Worsen by 2 | 0 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Trunk | -2 = Improve by 2 | 24 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Erythema - Lower Limbs | 0 = No change | 101 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Erythema - Head & Neck | 0 = No change | 121 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Trunk | -1 = Improve by 1 | 59 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Erythema - Lower Limbs | -1 = Improve by 1 | 64 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Lower Limbs | -2 = Improve by 2 | 13 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Trunk | 0 = No change | 114 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Erythema - Lower Limbs | -2 = Improve by 2 | 34 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Erythema - Trunk | 1 = Worsen by 1 | 3 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Trunk | 1 = Worsen by 1 | 4 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Erythema - Lower Limbs | -3 = Improve by 3 | 0 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Pruritus | -3 = Improve by 3 | 4 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Trunk | 2 = Worsen by 2 | 0 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Head & Neck | 3 = Worsen by 3 | 0 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Lower Limbs | -1 = Improve by 1 | 54 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Trunk | 3 = Worsen by 3 | 0 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Head & Neck | 2 = Worsen by 2 | 1 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Erythema - Trunk | 0 = No change | 106 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Head & Neck | -3 = Improve by 3 | 0 Participants |
| Test | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Head & Neck | 1 = Worsen by 1 | 0 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Lower Limbs | 1 = Worsen by 1 | 2 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Erythema - Head & Neck | 3 = Worsen by 3 | 0 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Erythema - Head & Neck | 2 = Worsen by 2 | 1 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Erythema - Head & Neck | 1 = Worsen by 1 | 5 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Erythema - Head & Neck | 0 = No change | 118 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Erythema - Head & Neck | -1 = Improve by 1 | 50 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Erythema - Head & Neck | -2 = Improve by 2 | 30 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Erythema - Head & Neck | -3 = Improve by 3 | 1 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Erythema - Trunk | 3 = Worsen by 3 | 0 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Erythema - Trunk | 2 = Worsen by 2 | 1 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Erythema - Trunk | 1 = Worsen by 1 | 4 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Erythema - Trunk | 0 = No change | 113 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Erythema - Trunk | -1 = Improve by 1 | 57 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Erythema - Trunk | -2 = Improve by 2 | 30 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Erythema - Trunk | -3 = Improve by 3 | 0 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Erythema - Upper Limbs | 3 = Worsen by 3 | 0 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Erythema - Upper Limbs | 2 = Worsen by 2 | 0 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Erythema - Upper Limbs | 1 = Worsen by 1 | 1 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Erythema - Upper Limbs | 0 = No change | 80 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Erythema - Upper Limbs | -1 = Improve by 1 | 91 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Erythema - Upper Limbs | -2 = Improve by 2 | 33 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Erythema - Upper Limbs | -3 = Improve by 3 | 0 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Erythema - Lower Limbs | 3 = Worsen by 3 | 0 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Erythema - Lower Limbs | 2 = Worsen by 2 | 0 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Erythema - Lower Limbs | 1 = Worsen by 1 | 4 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Erythema - Lower Limbs | 0 = No change | 109 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Erythema - Lower Limbs | -1 = Improve by 1 | 62 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Erythema - Lower Limbs | -2 = Improve by 2 | 30 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Erythema - Lower Limbs | -3 = Improve by 3 | 0 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Head & Neck | 3 = Worsen by 3 | 0 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Head & Neck | 2 = Worsen by 2 | 2 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Head & Neck | 1 = Worsen by 1 | 5 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Head & Neck | 0 = No change | 117 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Head & Neck | -1 = Improve by 1 | 57 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Head & Neck | -2 = Improve by 2 | 23 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Head & Neck | -3 = Improve by 3 | 1 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Trunk | 3 = Worsen by 3 | 0 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Trunk | 2 = Worsen by 2 | 1 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Trunk | 1 = Worsen by 1 | 4 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Trunk | 0 = No change | 110 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Trunk | -1 = Improve by 1 | 57 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Trunk | -2 = Improve by 2 | 33 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Trunk | -3 = Improve by 3 | 0 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Upper Limbs | 3 = Worsen by 3 | 0 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Upper Limbs | 2 = Worsen by 2 | 2 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Upper Limbs | 1 = Worsen by 1 | 5 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Upper Limbs | 0 = No change | 79 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Upper Limbs | -1 = Improve by 1 | 83 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Upper Limbs | -2 = Improve by 2 | 35 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Upper Limbs | -3 = Improve by 3 | 1 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Lower Limbs | 3 = Worsen by 3 | 0 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Lower Limbs | 2 = Worsen by 2 | 1 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Lower Limbs | 1 = Worsen by 1 | 2 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Lower Limbs | 0 = No change | 100 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Lower Limbs | -1 = Improve by 1 | 81 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Lower Limbs | -2 = Improve by 2 | 21 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Lower Limbs | -3 = Improve by 3 | 0 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Head & Neck | 3 = Worsen by 3 | 0 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Head & Neck | 2 = Worsen by 2 | 1 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Head & Neck | 1 = Worsen by 1 | 5 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Head & Neck | 0 = No change | 137 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Head & Neck | -1 = Improve by 1 | 41 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Head & Neck | -2 = Improve by 2 | 20 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Head & Neck | -3 = Improve by 3 | 1 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Trunk | 3 = Worsen by 3 | 0 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Trunk | 2 = Worsen by 2 | 0 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Trunk | 1 = Worsen by 1 | 6 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Trunk | 0 = No change | 126 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Trunk | -1 = Improve by 1 | 50 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Trunk | -2 = Improve by 2 | 23 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Trunk | -3 = Improve by 3 | 0 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Upper Limbs | 3 = Worsen by 3 | 0 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Upper Limbs | 2 = Worsen by 2 | 2 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Upper Limbs | 1 = Worsen by 1 | 6 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Upper Limbs | 0 = No change | 93 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Upper Limbs | -1 = Improve by 1 | 83 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Upper Limbs | -2 = Improve by 2 | 18 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Upper Limbs | -3 = Improve by 3 | 3 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Lower Limbs | 3 = Worsen by 3 | 0 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Lower Limbs | 2 = Worsen by 2 | 1 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Lower Limbs | 0 = No change | 113 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Lower Limbs | -1 = Improve by 1 | 71 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Lower Limbs | -2 = Improve by 2 | 16 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Lower Limbs | -3 = Improve by 3 | 2 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Pruritus | 3 = Worsen by 3 | 1 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Pruritus | 2 = Worsen by 2 | 1 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Pruritus | 1 = Worsen by 1 | 5 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Pruritus | 0 = No change | 41 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Pruritus | -1 = Improve by 1 | 78 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Pruritus | -2 = Improve by 2 | 71 Participants |
| Reference Standard | Change in Severity of Four Individual Signs and Symptoms | Pruritus | -3 = Improve by 3 | 8 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Head & Neck | -1 = Improve by 1 | 42 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Head & Neck | 1 = Worsen by 1 | 3 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Pruritus | 0 = No change | 59 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Head & Neck | -2 = Improve by 2 | 7 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Head & Neck | 2 = Worsen by 2 | 0 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Lower Limbs | -1 = Improve by 1 | 52 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Head & Neck | -3 = Improve by 3 | 0 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Head & Neck | 3 = Worsen by 3 | 0 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Erythema - Trunk | 2 = Worsen by 2 | 0 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Trunk | 3 = Worsen by 3 | 0 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Erythema - Lower Limbs | -3 = Improve by 3 | 1 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Erythema - Head & Neck | 1 = Worsen by 1 | 4 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Trunk | 2 = Worsen by 2 | 1 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Erythema - Lower Limbs | -2 = Improve by 2 | 30 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Lower Limbs | -2 = Improve by 2 | 18 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Trunk | 1 = Worsen by 1 | 6 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Erythema - Lower Limbs | -1 = Improve by 1 | 61 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Erythema - Trunk | 3 = Worsen by 3 | 0 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Trunk | 0 = No change | 127 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Erythema - Lower Limbs | 0 = No change | 106 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Erythema - Head & Neck | 3 = Worsen by 3 | 0 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Trunk | -1 = Improve by 1 | 50 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Erythema - Lower Limbs | 1 = Worsen by 1 | 4 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Lower Limbs | -3 = Improve by 3 | 1 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Trunk | -2 = Improve by 2 | 17 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Erythema - Lower Limbs | 2 = Worsen by 2 | 1 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Erythema - Head & Neck | -3 = Improve by 3 | 0 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Trunk | -3 = Improve by 3 | 2 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Erythema - Lower Limbs | 3 = Worsen by 3 | 0 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Pruritus | -1 = Improve by 1 | 82 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Upper Limbs | 3 = Worsen by 3 | 0 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Erythema - Upper Limbs | -3 = Improve by 3 | 1 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Pruritus | 3 = Worsen by 3 | 0 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Upper Limbs | 2 = Worsen by 2 | 1 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Erythema - Upper Limbs | -2 = Improve by 2 | 33 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Erythema - Head & Neck | -2 = Improve by 2 | 15 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Upper Limbs | 1 = Worsen by 1 | 12 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Erythema - Upper Limbs | -1 = Improve by 1 | 76 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Erythema - Head & Neck | 2 = Worsen by 2 | 1 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Upper Limbs | 0 = No change | 98 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Erythema - Upper Limbs | 0 = No change | 85 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Pruritus | 2 = Worsen by 2 | 0 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Upper Limbs | -1 = Improve by 1 | 65 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Erythema - Upper Limbs | 1 = Worsen by 1 | 7 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Erythema - Head & Neck | -1 = Improve by 1 | 48 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Upper Limbs | -2 = Improve by 2 | 26 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Erythema - Upper Limbs | 2 = Worsen by 2 | 1 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Upper Limbs | 0 = No change | 88 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Pruritus | -3 = Improve by 3 | 3 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Upper Limbs | -1 = Improve by 1 | 81 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Upper Limbs | 1 = Worsen by 1 | 6 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Upper Limbs | -3 = Improve by 3 | 1 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Upper Limbs | -2 = Improve by 2 | 26 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Upper Limbs | 2 = Worsen by 2 | 1 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Erythema - Upper Limbs | 3 = Worsen by 3 | 0 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Upper Limbs | -3 = Improve by 3 | 1 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Upper Limbs | 3 = Worsen by 3 | 0 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Pruritus | 1 = Worsen by 1 | 10 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Lower Limbs | 3 = Worsen by 3 | 0 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Trunk | -3 = Improve by 3 | 0 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Lower Limbs | 3 = Worsen by 3 | 0 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Lower Limbs | 2 = Worsen by 2 | 1 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Trunk | -2 = Improve by 2 | 34 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Erythema - Trunk | -3 = Improve by 3 | 1 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Lower Limbs | 1 = Worsen by 1 | 6 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Trunk | -1 = Improve by 1 | 55 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Erythema - Head & Neck | 0 = No change | 135 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Lower Limbs | 0 = No change | 116 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Trunk | 0 = No change | 108 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Lower Limbs | 2 = Worsen by 2 | 1 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Lower Limbs | -1 = Improve by 1 | 57 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Trunk | 1 = Worsen by 1 | 5 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Erythema - Trunk | -2 = Improve by 2 | 30 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Lower Limbs | -2 = Improve by 2 | 23 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Trunk | 2 = Worsen by 2 | 1 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Erythema - Trunk | -1 = Improve by 1 | 50 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Lower Limbs | -3 = Improve by 3 | 0 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Trunk | 3 = Worsen by 3 | 0 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Lower Limbs | 1 = Worsen by 1 | 5 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Head & Neck | 3 = Worsen by 3 | 0 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Head & Neck | -3 = Improve by 3 | 0 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Erythema - Trunk | 0 = No change | 116 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Head & Neck | 2 = Worsen by 2 | 1 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Head & Neck | -2 = Improve by 2 | 14 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Pruritus | -2 = Improve by 2 | 49 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Head & Neck | 1 = Worsen by 1 | 2 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Head & Neck | -1 = Improve by 1 | 51 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Lower Limbs | 0 = No change | 126 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Lichenification - Head & Neck | 0 = No change | 151 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Induration/Papulation - Head & Neck | 0 = No change | 135 Participants |
| Placebo | Change in Severity of Four Individual Signs and Symptoms | Erythema - Trunk | 1 = Worsen by 1 | 6 Participants |
Secondary
Evaluation of Application Site Reactions
Dryness, burning/stinging, erosion, edema, and pain
Time frame: Day 15
Population: Safety with data for this parameter
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Test | Evaluation of Application Site Reactions | Edema | Moderate | 4 Participants |
| Test | Evaluation of Application Site Reactions | Stinging/Burning | Severe | 0 Participants |
| Test | Evaluation of Application Site Reactions | Pain | Moderate | 4 Participants |
| Test | Evaluation of Application Site Reactions | Edema | Mild | 14 Participants |
| Test | Evaluation of Application Site Reactions | Erosion | None | 190 Participants |
| Test | Evaluation of Application Site Reactions | Pain | Mild | 18 Participants |
| Test | Evaluation of Application Site Reactions | Edema | None | 196 Participants |
| Test | Evaluation of Application Site Reactions | Erosion | Mild | 14 Participants |
| Test | Evaluation of Application Site Reactions | Dryness | Severe | 6 Participants |
| Test | Evaluation of Application Site Reactions | Erosion | Severe | 2 Participants |
| Test | Evaluation of Application Site Reactions | Erosion | Moderate | 8 Participants |
| Test | Evaluation of Application Site Reactions | Dryness | Mild | 64 Participants |
| Test | Evaluation of Application Site Reactions | Pain | None | 192 Participants |
| Test | Evaluation of Application Site Reactions | Stinging/Burning | None | 180 Participants |
| Test | Evaluation of Application Site Reactions | Pain | Severe | 0 Participants |
| Test | Evaluation of Application Site Reactions | Edema | Severe | 0 Participants |
| Test | Evaluation of Application Site Reactions | Stinging/Burning | Mild | 23 Participants |
| Test | Evaluation of Application Site Reactions | Dryness | None | 121 Participants |
| Test | Evaluation of Application Site Reactions | Stinging/Burning | Moderate | 11 Participants |
| Test | Evaluation of Application Site Reactions | Dryness | Moderate | 23 Participants |
| Reference Standard | Evaluation of Application Site Reactions | Pain | Mild | 16 Participants |
| Reference Standard | Evaluation of Application Site Reactions | Dryness | None | 126 Participants |
| Reference Standard | Evaluation of Application Site Reactions | Dryness | Mild | 63 Participants |
| Reference Standard | Evaluation of Application Site Reactions | Dryness | Moderate | 21 Participants |
| Reference Standard | Evaluation of Application Site Reactions | Dryness | Severe | 3 Participants |
| Reference Standard | Evaluation of Application Site Reactions | Stinging/Burning | None | 171 Participants |
| Reference Standard | Evaluation of Application Site Reactions | Stinging/Burning | Mild | 30 Participants |
| Reference Standard | Evaluation of Application Site Reactions | Stinging/Burning | Moderate | 11 Participants |
| Reference Standard | Evaluation of Application Site Reactions | Stinging/Burning | Severe | 1 Participants |
| Reference Standard | Evaluation of Application Site Reactions | Erosion | None | 187 Participants |
| Reference Standard | Evaluation of Application Site Reactions | Erosion | Mild | 19 Participants |
| Reference Standard | Evaluation of Application Site Reactions | Erosion | Moderate | 7 Participants |
| Reference Standard | Evaluation of Application Site Reactions | Erosion | Severe | 0 Participants |
| Reference Standard | Evaluation of Application Site Reactions | Edema | None | 194 Participants |
| Reference Standard | Evaluation of Application Site Reactions | Edema | Mild | 13 Participants |
| Reference Standard | Evaluation of Application Site Reactions | Edema | Moderate | 6 Participants |
| Reference Standard | Evaluation of Application Site Reactions | Edema | Severe | 0 Participants |
| Reference Standard | Evaluation of Application Site Reactions | Pain | None | 195 Participants |
| Reference Standard | Evaluation of Application Site Reactions | Pain | Moderate | 2 Participants |
| Reference Standard | Evaluation of Application Site Reactions | Pain | Severe | 0 Participants |
| Placebo | Evaluation of Application Site Reactions | Dryness | None | 103 Participants |
| Placebo | Evaluation of Application Site Reactions | Edema | Mild | 17 Participants |
| Placebo | Evaluation of Application Site Reactions | Stinging/Burning | Moderate | 14 Participants |
| Placebo | Evaluation of Application Site Reactions | Pain | Severe | 1 Participants |
| Placebo | Evaluation of Application Site Reactions | Edema | Moderate | 7 Participants |
| Placebo | Evaluation of Application Site Reactions | Stinging/Burning | None | 172 Participants |
| Placebo | Evaluation of Application Site Reactions | Pain | Moderate | 7 Participants |
| Placebo | Evaluation of Application Site Reactions | Edema | Severe | 0 Participants |
| Placebo | Evaluation of Application Site Reactions | Dryness | Severe | 5 Participants |
| Placebo | Evaluation of Application Site Reactions | Stinging/Burning | Mild | 28 Participants |
| Placebo | Evaluation of Application Site Reactions | Pain | None | 197 Participants |
| Placebo | Evaluation of Application Site Reactions | Dryness | Moderate | 33 Participants |
| Placebo | Evaluation of Application Site Reactions | Erosion | Moderate | 9 Participants |
| Placebo | Evaluation of Application Site Reactions | Erosion | Mild | 18 Participants |
| Placebo | Evaluation of Application Site Reactions | Dryness | Mild | 76 Participants |
| Placebo | Evaluation of Application Site Reactions | Erosion | Severe | 0 Participants |
| Placebo | Evaluation of Application Site Reactions | Erosion | None | 190 Participants |
| Placebo | Evaluation of Application Site Reactions | Pain | Mild | 12 Participants |
| Placebo | Evaluation of Application Site Reactions | Edema | None | 193 Participants |
| Placebo | Evaluation of Application Site Reactions | Stinging/Burning | Severe | 3 Participants |