지루성 피부염 및 구진농포성 주사에서의 PDE4 억제

실험적: Sebderm PF-07038124

PF-07038124 0.02% ointment once daily for 8 weeks

의약품: PF-07038124

국소 PDE4 억제제

위약 비교기: Sebderm Placebo

Placebo Ointment

의약품: 위약 연고

일치하는 위약

실험적: Rosacea PF-07038124

PF-07038124 0.02% ointment once daily for 8 weeks

의약품: PF-07038124

국소 PDE4 억제제

위약 비교기: Rosacea Placebo

Placebo Ointment

의약품: 위약 연고

일치하는 위약

Number of Subjects Reaching Investigator's Global Assessment (IGA) Success - Seborrheic Dermatitis (SD)

IGA success defined as: clear (0) or almost clear (1) and a reduction from baseline of ≥2 points score of 0 or 1 at 8 weeks. Full scale is scored from 0-4, higher score indicates more severe symptoms.

Clear (0) - Complete clear, no signs of SD

Almost Clear (1) - Only slight pink color or trace amounts of scaling

Mild (2) - Pink to red color, or slight

Moderate (3) - Distinct redness or clearly visible scaling

Severe (4) - Severe score in erythema or scaling

Percent Change in Lesion Count Papulopustular Rosacea (PPR)

Percent change from baseline in inflammation (papule/pustule) lesion count at 8 weeks

부작용의 심각성

심각도는 CTCAE 5.0에 따라 범주(경증, 보통, 심각)로 측정됩니다.

Change in SD Severity Score at 8 Weeks

Change from baseline in each component and overall SD score (composed of erythema, scaling, and pruritus components) at 8 weeks. Each component scored 0-4 (0 = absence, 1 = mild, 2 = moderate, 3 = significant, 4 = severe). Total score from 0-12. Higher score indicates more severe symptoms.

Number of Patients With Treatment Success Via IGA in PPR

IGA success is defined as clear (0) or almost clear (1),and a reduction from baseline of ≥2 points score of 0 or 1 at 8 weeks. Full scale is scored from 0-4, higher score indicates more severe symptoms.

Clear (0) - No inflammatory lesions present, no erythema

Almost Clear (1) - Very few, small papules/pustules, very mild erythema present

Mild (2) - Few small or large papules/pustules, moderate erythema

Moderate (3) - Several small or large papules/pustules, moderate erythema

Severe (4) - Numerous small and/or large papules/pustules, severe erythema

Percent Change in Clinical Erythema - PPR

Percent change from baseline in clinical erythema assessment at 8 weeks. Full scale is scored from 0-4, higher score indicates more severe symptoms.

Clear (0) -Clear skin with no signs of erythema

Almost Clear (1) - Almost clear; slight redness

Mild (2) - Mild erythema; definite redness

Moderate (3) - Moderate erythema; marked redness

Severe (4) - Severe erythema; fiery redness

Change in Patient Assessment of Erythema - PPR

Change from baseline in patient severity assessment of erythema at 8 weeks. Full scale is scored from 0-4, higher score indicates more severe symptoms.

Clear (0) - Clear of unwanted redness

Almost Clear (1) - Nearly clear of unwanted redness

Mild (2) - Somewhat more redness than I prefer

Moderate (3) - More redness than I prefer

Severe (4) - Completely unacceptable redness

Change in Lesion Count - PPR

Change from baseline and from 8 weeks in inflammatory (papule/pustule) lesion count at 12 weeks

Change in IGA Score - SD and PPR

Change from baseline in IGA score at 8 weeks. Full scale is scored from 0-4, higher score indicates more severe symptoms.

SD Clear 0 Complete clear, no signs of SD Almost Clear 1 Only slight pink color or trace amounts of scaling Mild 2 Pink to red color, or slight Moderate 3 Distinct redness or clearly visible scaling Severe 4 Severe score in erythema or scaling Clear (0) - Complete clear, no signs of SD

PPR Clear 0 No inflammatory lesions present, no erythema Almost Clear 1 Very few, small papules/pustules, very mild erythema present Mild 2 Few small or large papules/pustules, moderate erythema Moderate 3 Several small or large papules/pustules, moderate erythema Severe 4 Numerous small and/or large papules/pustules, severe erythema

Percent Change in IGA Score - SD and PPR

Percent change from baseline in IGA score at 8 weeks. Full scale is scored from 0-4, higher score indicates more severe symptoms.

SD Clear 0 Complete clear, no signs of SD Almost Clear 1 Only slight pink color or trace amounts of scaling Mild 2 Pink to red color, or slight Moderate 3 Distinct redness or clearly visible scaling Severe 4 Severe score in erythema or scaling Clear (0) - Complete clear, no signs of SD

PPR Clear 0 No inflammatory lesions present, no erythema Almost Clear 1 Very few, small papules/pustules, very mild erythema present Mild 2 Few small or large papules/pustules, moderate erythema Moderate 3 Several small or large papules/pustules, moderate erythema Severe 4 Numerous small and/or large papules/pustules, severe erythema

Change in IGA Score - SD and PPR

Change from baseline in IGA at 12 weeks (i.e., 4 weeks after treatment cessation). Full scale is scored from 0-4, higher score indicates more severe symptoms.

SD Clear 0 Complete clear, no signs of SD Almost Clear 1 Only slight pink color or trace amounts of scaling Mild 2 Pink to red color, or slight Moderate 3 Distinct redness or clearly visible scaling Severe 4 Severe score in erythema or scaling Clear (0) - Complete clear, no signs of SD

PPR Clear 0 No inflammatory lesions present, no erythema Almost Clear 1 Very few, small papules/pustules, very mild erythema present Mild 2 Few small or large papules/pustules, moderate erythema Moderate 3 Several small or large papules/pustules, moderate erythema Severe 4 Numerous small and/or large papules/pustules, severe erythema

Change in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Week 8

Change from baseline in PP-NRS at 8 weeks On a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', patient rates their itch at the worst moment during the previous 24 hours. Higher score indicates more severe symptoms.

Number of Study Drug Related Adverse Events

Number of adverse events reported throughout the study that are deemed related to study drug.

Frequency of Study Drug Related Adverse Events

The frequency at which adverse events that are deemed related to study drug are reported throughout the study.