Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Incidence and Severity of Treatment-Emergent adverse events |
The adverse event will be described and categorized as Treatment-emergent, Serious, abnormal in vital signals, and abnormal in laboratory parameters. |
Week 48 |
|
Primary |
Changes from baseline in CCL5 gene expression level in response to PF-06700841 |
mRNA Levels of CCL5 gene expression in skin biopsies quantified by normalized Ct values obtained by quantitative real-time PCR assay, measured at baseline, week 12 and week 24. Changes are characterized by differences in Ct values from a specific time point (week 12 or week 24) to baseline. |
Week 12 and Week 24 |
|
Primary |
Changes from baseline in CXCR3 gene expression level in response to PF-06700841 |
mRNA Levels of CXCR3 gene expression in skin biopsies quantified by normalized Ct values obtained by quantitative real-time PCR assay, measured at baseline, week 12 and week 24. Changes are characterized by differences in Ct values from a specific time point (week 12 or week 24) to baseline. |
Week 12 and Week 24 |
|
Secondary |
Changes from baseline in IFN-? gene expression level in response to PF-06700841 |
mRNA Levels of IFN-? gene expression in skin biopsies quantified by normalized Ct values obtained by quantitative real-time PCR assay, measured at baseline, week 12, week 24 and week 48. Changes are characterized by differences in Ct values from a specific time point (week 12, week 24 or week 48) to baseline. |
Week 12, Week 24 and Week 48 |
|
Secondary |
Changes from baseline in CXCL9 gene expression level in response to PF-06700841 |
mRNA Levels of CXCL9 gene expression in skin biopsies quantified by normalized Ct values obtained by quantitative real-time PCR assay, measured at baseline, week 12, week 24 and week 48. Changes are characterized by differences in Ct values from a specific time point (week 12, week 24 or week 48) to baseline. |
Week 12, Week 24 and Week 48 |
|
Secondary |
Changes from baseline in CXCL10 gene expression level in response to PF-06700841 |
mRNA Levels of CXCL10 gene expression in skin biopsies quantified by normalized Ct values obtained by quantitative real-time PCR assay, measured at baseline, week 12, week 24 and week 48. Changes are characterized by differences in Ct values from a specific time point (week 12, week 24 or week 48) to baseline. |
Week 12, Week 24 and Week 48 |
|
Secondary |
Changes from baseline in IL-12RB1 gene expression level in response to PF-06700841 |
mRNA Levels of IL-12RB1 gene expression in skin biopsies quantified by normalized Ct values obtained by quantitative real-time PCR assay, measured at baseline, week 12, week 24 and week 48. Changes are characterized by differences in Ct values from a specific time point (week 12, week 24 or week 48) to baseline. |
Week 12, Week 24 and Week 48 |
|
Secondary |
Changes from baseline in STAT1 gene expression level in response to PF-06700841 |
mRNA Levels of STAT1 gene expression in skin biopsies quantified by normalized Ct values obtained by quantitative real-time PCR assay, measured at baseline, week 12, week 24 and week 48. Changes are characterized by differences in Ct values from a specific time point (week 12, week 24 or week 48) to baseline. |
Week 12, Week 24 and Week 48 |
|
Secondary |
The Frontal Fibrosis Alopecia Severity Index (FFASI) |
The Frontal Fibrosis Alopecia Severity Index utilizes clinical images of the entire hairline divided into 4 sections. Score from 1-5, with higher score indicating more severity. |
Baseline |
|
Secondary |
The Frontal Fibrosis Alopecia Severity Index (FFASI) |
The Frontal Fibrosis Alopecia Severity Index utilizes clinical images of the entire hairline divided into 4 sections. Score from 1-5, with higher score indicating more severity. |
Week 12 |
|
Secondary |
The Frontal Fibrosis Alopecia Severity Index (FFASI) |
The Frontal Fibrosis Alopecia Severity Index utilizes clinical images of the entire hairline divided into 4 sections. Score from 1-5, with higher score indicating more severity. |
Week 24 |
|
Secondary |
The Frontal Fibrosis Alopecia Severity Index (FFASI) |
The Frontal Fibrosis Alopecia Severity Index utilizes clinical images of the entire hairline divided into 4 sections. Score from 1-5, with higher score indicating more severity. |
Week 48 |
|
Secondary |
The Lichen Planopilaris Activity Index (LPPAI) |
The Lichen Planopilaris Activity Index is a numeric composite index that aggregates symptoms and signs of pruritus, pain, burning, scalp erythema , perifollicular erythema, perifollicular scale , pull test and spreading. Symptoms and signs are measured in a 4-point scale (0-absent, 1-mild, 2-moderate and 3-severe). Full range from 0-10, higher score indicates more severity. |
Baseline |
|
Secondary |
The Lichen Planopilaris Activity Index (LPPAI) |
The Lichen Planopilaris Activity Index is a numeric composite index that aggregates symptoms and signs of pruritus, pain, burning, scalp erythema , perifollicular erythema, perifollicular scale , pull test and spreading. Symptoms and signs are measured in a 4-point scale (0-absent, 1-mild, 2-moderate and 3-severe). Full range from 0-10, higher score indicates more severity. |
Week 12 |
|
Secondary |
The Lichen Planopilaris Activity Index (LPPAI) |
The Lichen Planopilaris Activity Index is a numeric composite index that aggregates symptoms and signs of pruritus, pain, burning, scalp erythema , perifollicular erythema, perifollicular scale , pull test and spreading. Symptoms and signs are measured in a 4-point scale (0-absent, 1-mild, 2-moderate and 3-severe). Full range from 0-10, higher score indicates more severity. |
Week 24 |
|
Secondary |
The Lichen Planopilaris Activity Index (LPPAI) |
The Lichen Planopilaris Activity Index is a numeric composite index that aggregates symptoms and signs of pruritus, pain, burning, scalp erythema , perifollicular erythema, perifollicular scale , pull test and spreading. Symptoms and signs are measured in a 4-point scale (0-absent, 1-mild, 2-moderate and 3-severe). Full range from 0-10, higher score indicates more severity. |
Week 48 |
|
Secondary |
The Central Hair Loss Grade (CHLG) |
The Central Hair Loss Grade is a clinical measure of severity that uses a 6 points scale (0 no central scalp hair loss , 1 - minimal central scalp hair loss , 2 - clinically evident central scalp hair loss, 3-5 advanced central scalp hair loss) |
Baseline |
|
Secondary |
The Central Hair Loss Grade (CHLG) |
The Central Hair Loss Grade is a clinical measure of severity that uses a 6 points scale (0 no central scalp hair loss , 1 - minimal central scalp hair loss , 2 - clinically evident central scalp hair loss, 3-5 advanced central scalp hair loss) |
Week 12 |
|
Secondary |
The Central Hair Loss Grade (CHLG) |
The Central Hair Loss Grade is a clinical measure of severity that uses a 6 points scale (0 no central scalp hair loss , 1 - minimal central scalp hair loss , 2 - clinically evident central scalp hair loss, 3-5 advanced central scalp hair loss) |
Week 24 |
|
Secondary |
The Central Hair Loss Grade (CHLG) |
The Central Hair Loss Grade is a clinical measure of severity that uses a 6 points scale (0 no central scalp hair loss , 1 - minimal central scalp hair loss , 2 - clinically evident central scalp hair loss, 3-5 advanced central scalp hair loss) |
Week 48 |
|
Secondary |
Change in Physician Global Assessment of Improvement (PGA-I) |
The PGA-I ranges from -4(significant worsening) to 4(significant improvement). |
Week 24 |
|
Secondary |
Change in Physician Global Assessment of Improvement (PGA-I) |
The PGA-I ranges from -4(significant worsening) to 4(significant improvement). |
Week 28 |
|
Secondary |
Change in the Dermatology Quality of Life Index (DLQI) |
DLQI is a questionnaire with quality of life indicators related to the health of the skin. This questionnaire has 10 items related to skin problems, each one with 4 possible answers: Very Much, A Lot, A Little, and Not at All. The sum of items scores will generate a score of how much the skin problem affects the personal life. Full score range from 0 to 30, with higher score indicating poorer health outcomes. |
Baseline |
|
Secondary |
Change in the Dermatology Quality of Life Index (DLQI) |
DLQI is a questionnaire with quality of life indicators related to the health of the skin. This questionnaire has 10 items related to skin problems, each one with 4 possible answers: Very Much, A Lot, A Little, and Not at All. The sum of items scores will generate a score of how much the skin problem affects the personal life. Full score range from 0 to 30, with higher score indicating poorer health outcomes. |
Week 12 |
|
Secondary |
Change in the Dermatology Quality of Life Index (DLQI) |
DLQI is a questionnaire with quality of life indicators related to the health of the skin. This questionnaire has 10 items related to skin problems, each one with 4 possible answers: Very Much, A Lot, A Little, and Not at All. The sum of items scores will generate a score of how much the skin problem affects the personal life. Full score range from 0 to 30, with higher score indicating poorer health outcomes. |
Week 24 |
|
Secondary |
Change in the Dermatology Quality of Life Index (DLQI) |
DLQI is a questionnaire with quality of life indicators related to the health of the skin. This questionnaire has 10 items related to skin problems, each one with 4 possible answers: Very Much, A Lot, A Little, and Not at All. The sum of items scores will generate a score of how much the skin problem affects the personal life. Full score range from 0 to 30, with higher score indicating poorer health outcomes. |
Week 48 |
|