Trial Outcomes & Findings for PDE4 Inhibition in Seborrheic Dermatitis and Papulopustular Rosacea (NCT NCT06013371)

Last Updated: 2026-08-14

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

32 participants

Primary outcome timeframe

Baseline and Week 8

Results posted on

2026-08-14

Participant Flow

Participant milestones

Participant milestones
Measure	Sebderm PF-07038124 PF-07038124 0.02% ointment once daily for 8 weeks PF-07038124: topical PDE4 inhibitor	Sebderm Placebo Placebo Ointment Placebo Ointment: matching placebo	Rosacea PF-07038124 PF-07038124 0.02% ointment once daily for 8 weeks PF-07038124: topical PDE4 inhibitor	Rosacea Placebo Placebo Ointment Placebo Ointment: matching placebo
Overall Study STARTED	13	7	8	4
Overall Study COMPLETED	13	5	7	3
Overall Study NOT COMPLETED	0	2	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Sebderm Placebo Placebo Ointment Placebo Ointment: matching placebo	Rosacea PF-07038124 PF-07038124 0.02% ointment once daily for 8 weeks PF-07038124: topical PDE4 inhibitor	Rosacea Placebo Placebo Ointment Placebo Ointment: matching placebo
Overall Study Lack of Efficacy	0	1	1
Overall Study Lost to Follow-up	1	0	0
Overall Study Death	1	0	0

Baseline Characteristics

Data for participants with Seborrheic Dermatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sebderm PF-07038124 n=13 Participants PF-07038124 0.02% ointment once daily for 8 weeks PF-07038124: topical PDE4 inhibitor	Sebderm Placebo n=7 Participants Placebo Ointment Placebo Ointment: matching placebo	Rosacea PF-07038124 n=8 Participants PF-07038124 0.02% ointment once daily for 8 weeks PF-07038124: topical PDE4 inhibitor	Rosacea Placebo n=4 Participants Placebo Ointment Placebo Ointment: matching placebo	Total n=32 Participants Total of all reporting groups
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=13 Participants	1 Participants n=7 Participants	5 Participants n=8 Participants	2 Participants n=4 Participants	14 Participants n=32 Participants
Age, Continuous	52 years STANDARD_DEVIATION 15 • n=13 Participants	38 years STANDARD_DEVIATION 16 • n=7 Participants	48 years STANDARD_DEVIATION 13 • n=8 Participants	43 years STANDARD_DEVIATION 9 • n=4 Participants	48 years STANDARD_DEVIATION 16 • n=32 Participants
Sex: Female, Male Female	4 Participants n=13 Participants	3 Participants n=7 Participants	3 Participants n=8 Participants	2 Participants n=4 Participants	12 Participants n=32 Participants
Sex: Female, Male Male	9 Participants n=13 Participants	4 Participants n=7 Participants	5 Participants n=8 Participants	2 Participants n=4 Participants	20 Participants n=32 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=13 Participants	6 Participants n=7 Participants	3 Participants n=8 Participants	2 Participants n=4 Participants	18 Participants n=32 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=13 Participants	0 Participants n=7 Participants	0 Participants n=8 Participants	0 Participants n=4 Participants	0 Participants n=32 Participants
Sebderm IGA IGA Score of 3	10 Participants n=13 Participants • Data for participants with Seborrheic Dermatitis	2 Participants n=7 Participants • Data for participants with Seborrheic Dermatitis	—	—	12 Participants n=20 Participants • Data for participants with Seborrheic Dermatitis
Sebderm IGA IGA Score of 4	3 Participants n=13 Participants • Data for participants with Seborrheic Dermatitis	5 Participants n=7 Participants • Data for participants with Seborrheic Dermatitis	—	—	8 Participants n=20 Participants • Data for participants with Seborrheic Dermatitis
SD Severity Scaling	2 units on a scale STANDARD_DEVIATION 1 • n=13 Participants • Data for participants with Papulopustular Rosacea	3 units on a scale STANDARD_DEVIATION 1 • n=7 Participants • Data for participants with Papulopustular Rosacea	—	—	3 units on a scale STANDARD_DEVIATION 1 • n=20 Participants • Data for participants with Papulopustular Rosacea
SD Severity Erythema	3 units on a scale STANDARD_DEVIATION 0 • n=13 Participants • Data for participants with Papulopustular Rosacea	3 units on a scale STANDARD_DEVIATION 1 • n=7 Participants • Data for participants with Papulopustular Rosacea	—	—	3 units on a scale STANDARD_DEVIATION 1 • n=20 Participants • Data for participants with Papulopustular Rosacea
SD Severity Pruritus	2 units on a scale STANDARD_DEVIATION 1 • n=13 Participants • Data for participants with Papulopustular Rosacea	3 units on a scale STANDARD_DEVIATION 1 • n=7 Participants • Data for participants with Papulopustular Rosacea	—	—	2 units on a scale STANDARD_DEVIATION 1 • n=20 Participants • Data for participants with Papulopustular Rosacea
SD Severity Total	8 units on a scale STANDARD_DEVIATION 1 • n=13 Participants • Data for participants with Papulopustular Rosacea	9 units on a scale STANDARD_DEVIATION 2 • n=7 Participants • Data for participants with Papulopustular Rosacea	—	—	8 units on a scale STANDARD_DEVIATION 1 • n=20 Participants • Data for participants with Papulopustular Rosacea
PPR Inflammatory Lesion Count	—	—	21 lesions STANDARD_DEVIATION 8 • n=8 Participants • Data for participants with Papulopustular Rosacea	16 lesions STANDARD_DEVIATION 3 • n=4 Participants • Data for participants with Papulopustular Rosacea	19 lesions STANDARD_DEVIATION 7 • n=12 Participants • Data for participants with Papulopustular Rosacea
PPR IGA Score IGA Score of 3	—	—	5 Participants n=8 Participants • Data for participants with Papulopustular Rosacea	4 Participants n=4 Participants • Data for participants with Papulopustular Rosacea	9 Participants n=12 Participants • Data for participants with Papulopustular Rosacea
PPR IGA Score IGA Score of 4	—	—	3 Participants n=8 Participants • Data for participants with Papulopustular Rosacea	0 Participants n=4 Participants • Data for participants with Papulopustular Rosacea	3 Participants n=12 Participants • Data for participants with Papulopustular Rosacea
Number of Participants with PPR Clinical Patient Erythema Assessment Score 3 or 4 Score of 3	—	—	6 Participants n=8 Participants • Data for participants with Papulopustular Rosacea	4 Participants n=4 Participants • Data for participants with Papulopustular Rosacea	10 Participants n=12 Participants • Data for participants with Papulopustular Rosacea
Number of Participants with PPR Clinical Patient Erythema Assessment Score 3 or 4 Score of 4	—	—	2 Participants n=8 Participants • Data for participants with Papulopustular Rosacea	0 Participants n=4 Participants • Data for participants with Papulopustular Rosacea	2 Participants n=12 Participants • Data for participants with Papulopustular Rosacea
PPR Clinical Patient Severity Assessment Score Score of 0	—	—	1 Participants n=8 Participants • Data for participants with Papulopustular Rosacea	0 Participants n=4 Participants • Data for participants with Papulopustular Rosacea	1 Participants n=12 Participants • Data for participants with Papulopustular Rosacea
PPR Clinical Patient Severity Assessment Score Score of 3	—	—	3 Participants n=8 Participants • Data for participants with Papulopustular Rosacea	2 Participants n=4 Participants • Data for participants with Papulopustular Rosacea	5 Participants n=12 Participants • Data for participants with Papulopustular Rosacea
PPR Clinical Patient Severity Assessment Score Score of 4	—	—	4 Participants n=8 Participants • Data for participants with Papulopustular Rosacea	2 Participants n=4 Participants • Data for participants with Papulopustular Rosacea	6 Participants n=12 Participants • Data for participants with Papulopustular Rosacea

PRIMARY outcome

Timeframe: Baseline and Week 8

Outcome measures

Outcome measures
Measure	Sebderm PF-07038124 n=13 Participants PF-07038124 0.02% ointment once daily for 8 weeks PF-07038124: topical PDE4 inhibitor	Sebderm Placebo n=7 Participants Placebo Ointment Placebo Ointment: matching placebo	Rosacea PF-07038124 PF-07038124 0.02% ointment once daily for 8 weeks PF-07038124: topical PDE4 inhibitor	Rosacea Placebo Placebo Ointment Placebo Ointment: matching placebo
Number of Subjects Reaching Investigator's Global Assessment (IGA) Success - Seborrheic Dermatitis (SD)	8 Participants	1 Participants	—	—

PRIMARY outcome

Timeframe: Baseline and Week 8

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

Outcome measures

Outcome measures
Measure	Sebderm PF-07038124 n=8 Participants PF-07038124 0.02% ointment once daily for 8 weeks PF-07038124: topical PDE4 inhibitor	Sebderm Placebo n=4 Participants Placebo Ointment Placebo Ointment: matching placebo	Rosacea PF-07038124 PF-07038124 0.02% ointment once daily for 8 weeks PF-07038124: topical PDE4 inhibitor	Rosacea Placebo Placebo Ointment Placebo Ointment: matching placebo
Percent Change in Lesion Count Papulopustular Rosacea (PPR)	-13 percent change Standard Deviation 30	-56 percent change Standard Deviation 27	—	—

SECONDARY outcome

Timeframe: Baseline and 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.

Outcome measures

Outcome measures
Measure	Sebderm PF-07038124 n=13 Participants PF-07038124 0.02% ointment once daily for 8 weeks PF-07038124: topical PDE4 inhibitor	Sebderm Placebo n=7 Participants Placebo Ointment Placebo Ointment: matching placebo	Rosacea PF-07038124 PF-07038124 0.02% ointment once daily for 8 weeks PF-07038124: topical PDE4 inhibitor	Rosacea Placebo Placebo Ointment Placebo Ointment: matching placebo
Change in SD Severity Score at 8 Weeks Overall	-6 score on a scale Standard Deviation 2	-4 score on a scale Standard Deviation 2	—	—
Change in SD Severity Score at 8 Weeks Pruritus	-2 score on a scale Standard Deviation 1	-1 score on a scale Standard Deviation 1	—	—
Change in SD Severity Score at 8 Weeks Erythema	-2 score on a scale Standard Deviation 1	-1 score on a scale Standard Deviation 0	—	—
Change in SD Severity Score at 8 Weeks Scaling	-2 score on a scale Standard Deviation 1	-1 score on a scale Standard Deviation 1	—	—

SECONDARY outcome

Timeframe: Baseline and 8 weeks

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

Outcome measures

Outcome measures
Measure	Sebderm PF-07038124 n=8 Participants PF-07038124 0.02% ointment once daily for 8 weeks PF-07038124: topical PDE4 inhibitor	Sebderm Placebo n=4 Participants Placebo Ointment Placebo Ointment: matching placebo	Rosacea PF-07038124 PF-07038124 0.02% ointment once daily for 8 weeks PF-07038124: topical PDE4 inhibitor	Rosacea Placebo Placebo Ointment Placebo Ointment: matching placebo
Number of Patients With Treatment Success Via IGA in PPR	0 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: Baseline and 8 weeks

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

Outcome measures

Outcome measures
Measure	Sebderm PF-07038124 n=8 Participants PF-07038124 0.02% ointment once daily for 8 weeks PF-07038124: topical PDE4 inhibitor	Sebderm Placebo n=4 Participants Placebo Ointment Placebo Ointment: matching placebo	Rosacea PF-07038124 PF-07038124 0.02% ointment once daily for 8 weeks PF-07038124: topical PDE4 inhibitor	Rosacea Placebo Placebo Ointment Placebo Ointment: matching placebo
Percent Change in Clinical Erythema - PPR	-8 percent change in score on a scale Standard Deviation 14	-22 percent change in score on a scale Standard Deviation 38	—	—

SECONDARY outcome

Timeframe: Baseline and 8 weeks

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

Outcome measures

Outcome measures
Measure	Sebderm PF-07038124 n=8 Participants PF-07038124 0.02% ointment once daily for 8 weeks PF-07038124: topical PDE4 inhibitor	Sebderm Placebo n=4 Participants Placebo Ointment Placebo Ointment: matching placebo	Rosacea PF-07038124 PF-07038124 0.02% ointment once daily for 8 weeks PF-07038124: topical PDE4 inhibitor	Rosacea Placebo Placebo Ointment Placebo Ointment: matching placebo
Change in Patient Assessment of Erythema - PPR	-0.29 score on a scale Standard Deviation 0.76	-0.67 score on a scale Standard Deviation 1.15	—	—

SECONDARY outcome

Timeframe: Baseline, 8 weeks, 12 weeks

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

Outcome measures

Outcome measures
Measure	Sebderm PF-07038124 n=8 Participants PF-07038124 0.02% ointment once daily for 8 weeks PF-07038124: topical PDE4 inhibitor	Sebderm Placebo n=4 Participants Placebo Ointment Placebo Ointment: matching placebo	Rosacea PF-07038124 PF-07038124 0.02% ointment once daily for 8 weeks PF-07038124: topical PDE4 inhibitor	Rosacea Placebo Placebo Ointment Placebo Ointment: matching placebo
Change in Lesion Count - PPR week 8 to week 12	0 change in lesion count Standard Deviation 2	1 change in lesion count Standard Deviation 6	—	—
Change in Lesion Count - PPR baseline to week 12	-3 change in lesion count Standard Deviation 6	-6 change in lesion count Standard Deviation 5	—	—

SECONDARY outcome

Timeframe: Baseline and 8 weeks

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

Outcome measures

Outcome measures
Measure	Sebderm PF-07038124 n=13 Participants PF-07038124 0.02% ointment once daily for 8 weeks PF-07038124: topical PDE4 inhibitor	Sebderm Placebo n=7 Participants Placebo Ointment Placebo Ointment: matching placebo	Rosacea PF-07038124 n=8 Participants PF-07038124 0.02% ointment once daily for 8 weeks PF-07038124: topical PDE4 inhibitor	Rosacea Placebo n=4 Participants Placebo Ointment Placebo Ointment: matching placebo
Change in IGA Score - SD and PPR Baseline	3 score on a scale Interval 3.0 to 3.0	3 score on a scale Interval 3.0 to 4.0	3 score on a scale Interval 3.0 to 4.0	3 score on a scale Interval 3.0 to 3.0
Change in IGA Score - SD and PPR Week 8	1 score on a scale Interval 1.0 to 3.0	2 score on a scale Interval 2.0 to 3.0	3 score on a scale Interval 3.0 to 3.5	3 score on a scale Interval 2.0 to 3.0

SECONDARY outcome

Timeframe: Baseline and 8 weeks

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

Outcome measures

Outcome measures
Measure	Sebderm PF-07038124 n=13 Participants PF-07038124 0.02% ointment once daily for 8 weeks PF-07038124: topical PDE4 inhibitor	Sebderm Placebo n=7 Participants Placebo Ointment Placebo Ointment: matching placebo	Rosacea PF-07038124 n=8 Participants PF-07038124 0.02% ointment once daily for 8 weeks PF-07038124: topical PDE4 inhibitor	Rosacea Placebo n=4 Participants Placebo Ointment Placebo Ointment: matching placebo
Percent Change in IGA Score - SD and PPR	-53.2051 percent change Standard Error 9.2709	-33.3333 percent change Standard Error 12.0761	-8.3333 percent change Standard Error 5.4554	-22.2222 percent change Standard Error 22.2222

SECONDARY outcome

Timeframe: Baseline and Week 12

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

Outcome measures

Outcome measures
Measure	Sebderm PF-07038124 n=13 Participants PF-07038124 0.02% ointment once daily for 8 weeks PF-07038124: topical PDE4 inhibitor	Sebderm Placebo n=7 Participants Placebo Ointment Placebo Ointment: matching placebo	Rosacea PF-07038124 n=8 Participants PF-07038124 0.02% ointment once daily for 8 weeks PF-07038124: topical PDE4 inhibitor	Rosacea Placebo n=4 Participants Placebo Ointment Placebo Ointment: matching placebo
Change in IGA Score - SD and PPR Baseline	3 score on a scale Inter-Quartile Range 7.0221 • Interval 3.0 to 3.0	3 score on a scale Inter-Quartile Range 13.7941 • Interval 3.0 to 4.0	3 score on a scale Inter-Quartile Range NA • Interval 3.0 to 4.0	3 score on a scale Inter-Quartile Range 0.2113 • Interval 3.0 to 3.0
Change in IGA Score - SD and PPR Week 12	2 score on a scale Interval 1.0 to 2.0	2 score on a scale Interval 1.0 to 3.0	3 score on a scale Interval 3.0 to 4.0	3 score on a scale Interval 2.5 to 3.0

SECONDARY outcome

Timeframe: Baseline and 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.

Outcome measures

Outcome measures
Measure	Sebderm PF-07038124 n=13 Participants PF-07038124 0.02% ointment once daily for 8 weeks PF-07038124: topical PDE4 inhibitor	Sebderm Placebo n=7 Participants Placebo Ointment Placebo Ointment: matching placebo	Rosacea PF-07038124 n=8 Participants PF-07038124 0.02% ointment once daily for 8 weeks PF-07038124: topical PDE4 inhibitor	Rosacea Placebo n=4 Participants Placebo Ointment Placebo Ointment: matching placebo
Change in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Week 8	-2.5833 score on a scale Standard Error 0.9249	-1.6 score on a scale Standard Error 1.5684	-1.1429 score on a scale Standard Error 0.6335	-0.6667 score on a scale Standard Error 0.6667

SECONDARY outcome

Timeframe: 12 weeks

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

Outcome measures

Outcome measures
Measure	Sebderm PF-07038124 n=13 Participants PF-07038124 0.02% ointment once daily for 8 weeks PF-07038124: topical PDE4 inhibitor	Sebderm Placebo n=7 Participants Placebo Ointment Placebo Ointment: matching placebo	Rosacea PF-07038124 n=8 Participants PF-07038124 0.02% ointment once daily for 8 weeks PF-07038124: topical PDE4 inhibitor	Rosacea Placebo n=4 Participants Placebo Ointment Placebo Ointment: matching placebo
Number of Study Drug Related Adverse Events	0 Events	1 Events	1 Events	0 Events

SECONDARY outcome

Timeframe: 12 weeks

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

Outcome measures

Outcome measures
Measure	Sebderm PF-07038124 n=13 Participants PF-07038124 0.02% ointment once daily for 8 weeks PF-07038124: topical PDE4 inhibitor	Sebderm Placebo n=7 Participants Placebo Ointment Placebo Ointment: matching placebo	Rosacea PF-07038124 n=8 Participants PF-07038124 0.02% ointment once daily for 8 weeks PF-07038124: topical PDE4 inhibitor	Rosacea Placebo n=4 Participants Placebo Ointment Placebo Ointment: matching placebo
Frequency of Study Drug Related Adverse Events	0 events	1 events	1 events	0 events

SECONDARY outcome

Timeframe: 12 weeks

Severity will be measured as a category (mild, Moderate, severe) according to CTCAE 5.0.

Outcome measures

Outcome measures
Measure	Sebderm Placebo n=7 Participants Placebo Ointment Placebo Ointment: matching placebo	Rosacea PF-07038124 n=8 Participants PF-07038124 0.02% ointment once daily for 8 weeks PF-07038124: topical PDE4 inhibitor	Rosacea Placebo n=4 Participants Placebo Ointment Placebo Ointment: matching placebo
Severity of Adverse Events Severe	0 Events	0 Events	0 Events
Severity of Adverse Events Moderate	1 Events	1 Events	0 Events
Severity of Adverse Events Mild	0 Events	1 Events	1 Events

Adverse Events

Sebderm PF-07038124

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sebderm Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

Rosacea PF-07038124

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Rosacea Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Sebderm PF-07038124 n=13 participants at risk PF-07038124 0.02% ointment once daily for 8 weeks PF-07038124: topical PDE4 inhibitor	Sebderm Placebo n=7 participants at risk Placebo Ointment Placebo Ointment: matching placebo	Rosacea PF-07038124 n=8 participants at risk PF-07038124 0.02% ointment once daily for 8 weeks PF-07038124: topical PDE4 inhibitor	Rosacea Placebo n=4 participants at risk Placebo Ointment Placebo Ointment: matching placebo
Ear and labyrinth disorders Acute Otitis Media	0.00% 0/13 • 14 weeks Adverse events are reported for participants in study drug arm versus placebo regardless of dermatologic condition.	0.00% 0/7 • 14 weeks Adverse events are reported for participants in study drug arm versus placebo regardless of dermatologic condition.	12.5% 1/8 • 14 weeks Adverse events are reported for participants in study drug arm versus placebo regardless of dermatologic condition.	0.00% 0/4 • 14 weeks Adverse events are reported for participants in study drug arm versus placebo regardless of dermatologic condition.
Skin and subcutaneous tissue disorders Facial Irritation	0.00% 0/13 • 14 weeks Adverse events are reported for participants in study drug arm versus placebo regardless of dermatologic condition.	14.3% 1/7 • 14 weeks Adverse events are reported for participants in study drug arm versus placebo regardless of dermatologic condition.	0.00% 0/8 • 14 weeks Adverse events are reported for participants in study drug arm versus placebo regardless of dermatologic condition.	0.00% 0/4 • 14 weeks Adverse events are reported for participants in study drug arm versus placebo regardless of dermatologic condition.
Infections and infestations Nasopharyngitis	0.00% 0/13 • 14 weeks Adverse events are reported for participants in study drug arm versus placebo regardless of dermatologic condition.	0.00% 0/7 • 14 weeks Adverse events are reported for participants in study drug arm versus placebo regardless of dermatologic condition.	12.5% 1/8 • 14 weeks Adverse events are reported for participants in study drug arm versus placebo regardless of dermatologic condition.	0.00% 0/4 • 14 weeks Adverse events are reported for participants in study drug arm versus placebo regardless of dermatologic condition.
Infections and infestations Urinary Tract Infection (UTI)	0.00% 0/13 • 14 weeks Adverse events are reported for participants in study drug arm versus placebo regardless of dermatologic condition.	0.00% 0/7 • 14 weeks Adverse events are reported for participants in study drug arm versus placebo regardless of dermatologic condition.	0.00% 0/8 • 14 weeks Adverse events are reported for participants in study drug arm versus placebo regardless of dermatologic condition.	25.0% 1/4 • 14 weeks Adverse events are reported for participants in study drug arm versus placebo regardless of dermatologic condition.

Additional Information

Giselle Singer

Icahn School of Medicine at Mount Sinai

Phone: 212-241-3288

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place