TerminatedNCT06013371Updated Aug 14, 2026Results posted

PDE4 Inhibition in Seborrheic Dermatitis and Papulopustular Rosacea

A Phase 2 interventional study of PF-07038124 and Placebo Ointment in Seborrheic Dermatitis and Papulopustular Rosacea, sponsored by Icahn School of Medicine at Mount Sinai. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-14.

Sponsored by Icahn School of Medicine at Mount Sinai · Phase 2, Interventional, and Treatment

Why this study was terminated

The study ended early after interim analysis.

Phase: Phase 2
Study type: Interventional
Enrollment: 32
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

This study is a double-blind, vehicle-controlled clinical trial. The study will take place at Icahn School of Medicine at Mount Sinai. The study will include 33-39 adult subjects with moderate-to-severe-Seborrheic dermatitis (SD) as well as 33-39 adult subjects with moderate-to-severe papulopustular rosacea (PPR). Subjects will be randomized 2:1 to receive study drug or placebo.

Enrolled subjects will apply topical PF-07038124 0.02% ointment once daily for 8 weeks. They will return for visits at weeks 4, 8, and 12 following study treatment initiation for repeat clinical assessments, medication reviews, tape-strip, blood and urine sample collections, and monitoring for adverse events.

Read the detailed description

After providing consent, all subjects will be assessed for study eligibility, which includes a review of the subjects past and current medical conditions, familial medical history and detailed review of past and current medications. Subjects will also undergo a review of past topical treatments/therapies for SD or PPR, and clinical assessments (SD: clinical SD score, IGA, Peak Pruritus Numerical Rating Scale [PP-NRS]; PPR: inflammatory lesion count, IGA, PP-NRS).

Subjects who meet inclusion criteria for eligibility may continue with the Baseline Visit (Week 0) or can be scheduled to return for the Baseline Visit within 28 days of the Screening Visit.

At Baseline/Week 0, subjects will undergo clinical assessments (SD: clinical SD Severity Score, IGA, PP-NRS; PPR: inflammatory lesion count, IGA, PP-NRS), review of concomitant medications, standardized clinical photography, and a Dermatology Life Quality index (DLQI) questionnaire. Subsequent clinical assessments including standardized clinical photography, and questionnaire completion will be performed at follow up visits at Week 4, Week 8, and Week 12. Skin tape-strip samples will be collected for mechanistic studies (described below) at baseline (lesional and non-lesional facial skin), Week 4 (lesional facial skin), Week 8 (lesional facial skin), and Week 12 (lesional facial skin). Additional blood samples will be collected and stored at baseline and at Week 8 (or early termination, whichever is first) for potential future mechanistic analyses.

Conditions studied

Seborrheic Dermatitis
Papulopustular Rosacea

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Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Male or female subjects ≥ 18 years of age at the time of signing the informed consent document.
Subject is able to understand and voluntarily sign an informed consent document prior to participation in any study assessments or procedures.
Subject is able to adhere to the study visit schedule and other protocol requirements.
Diagnosis of SD and baseline IGA ≥ 3 with facial involvement
OR
Diagnosis of PPR, baseline IGA ≥ 3, and baseline inflammatory lesion count ≥ 12
Subject agrees to discontinue all treatments for SD and PPR from screening through study completion aside from the study drug
Subject is judged to be in otherwise good overall health as judged by the investigator, based on medical history, physical examination, and laboratory testing. (NOTE: The definition of good health means a subject does not have uncontrolled significant co-morbid conditions).
Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. While on the study drug and for at least 90 days after the last application of the study drug, male and female participants must be willing to take appropriate contraceptive measures to avoid pregnancy or fathering a child. FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options described below:
- Option 1: Any one of the following highly effective contraceptive methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy.
- OR
- Option 2: Male or female condom (latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]); PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide.

The female subject's chosen form of contraception must be effective by the time the female subject is enrolled into the study.

Exclusion criteria

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment:

Subjects with other skin diseases that would interfere with the study assessment in the opinion of the investigator.
Active bacterial, fungal, or viral skin infection within 2 weeks from study initiation.
Subject has clinically significant (as determined by the investigator) renal, hepatic, hematologic, intestinal, endocrine, pulmonary, cardiovascular, neurological, psychiatric, immunologic, or other major uncontrolled diseases (e.g., malignancy, TB, thromboembolic events) that will affect the health of the subject during the study, or interfere with the interpretation of study results.
Subject has previously received treatment with oral or topical PDE4 inhibitors.
Current other topical treatments (e.g., topical corticosteroids, topical calcineurin inhibitors, topical JAK inhibitors, topical metronidazole, topical minocycline, topical ivermectin, topical azelaic acid, topical brimonidine, topical oxymetazalone, topical antihistamines, topical antibacterials) within 2 weeks of baseline.
Use of systemic non-biologic immunosuppressive medications, including, but not limited to, cyclosporine, systemic or intralesional corticosteroids, mycophenolate mofetil, azathioprine, methotrexate, tacrolimus, oral JAK inhibitors within 4 weeks of study initiation.
Use of systemic biologic immunosuppressive medications, including, but not limited to inhibitors of IL-17, IL-12/23, or IL-23, TNF inhibitors, dupilumab, and abatacept within 12 weeks of baseline.
History of adverse systemic or allergic reactions to any component of the study drug.
Current participation in any other study with a biologic investigational medication within 6 months of baseline, or non-biologic investigational medication within 12 weeks of baseline.
Subject who is pregnant or breast feeding.
SD or PPR Baseline IGA \< 3; PPR inflammatory lesion count \<12; SD with no facial involvement.
Active hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or positive HIV serology at the time of screening for subjects determined by the investigators to be at high-risk for this disease.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 32 participants (actual)

Study arms

Experimental
Sebderm PF-07038124
PF-07038124 0.02% ointment once daily for 8 weeks
Drug: PF-07038124
Placebo comparator
Sebderm Placebo
Placebo Ointment
Drug: Placebo Ointment
Experimental
Rosacea PF-07038124
PF-07038124 0.02% ointment once daily for 8 weeks
Drug: PF-07038124
Placebo comparator
Rosacea Placebo
Placebo Ointment
Drug: Placebo Ointment

Interventions

DrugPF-07038124
topical PDE4 inhibitor
DrugPlacebo Ointment
matching placebo

What researchers measure

Primary outcomes

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
Time frame: Baseline and Week 8
Percent Change in Lesion Count Papulopustular Rosacea (PPR)
Percent change from baseline in inflammation (papule/pustule) lesion count at 8 weeks
Time frame: Baseline and Week 8

Secondary outcomes

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.
Time frame: Baseline and 8 weeks
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
Time frame: Baseline and 8 weeks
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
Time frame: Baseline and 8 weeks
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
Time frame: Baseline and 8 weeks
Change in Lesion Count - PPR
Change from baseline and from 8 weeks in inflammatory (papule/pustule) lesion count at 12 weeks
Time frame: Baseline, 8 weeks, 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
Time frame: Baseline and 8 weeks
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
Time frame: Baseline and 8 weeks
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
Time frame: Baseline and Week 12
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.
Time frame: Baseline and Week 8
Number of Study Drug Related Adverse Events
Number of adverse events reported throughout the study that are deemed related to study drug.
Time frame: 12 weeks
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.
Time frame: 12 weeks
Severity of Adverse Events
Severity will be measured as a category (mild, Moderate, severe) according to CTCAE 5.0.
Time frame: 12 weeks

Results

Posted Aug 14, 2026

Participant flow

Participant flow — Overall Study
Milestone	Sebderm PF-07038124	Sebderm Placebo	Rosacea PF-07038124	Rosacea Placebo
Started	13	7	8	4
Completed	13	5	7	3
Not completed	0	2	1	1
Withdrew: Lack of efficacy	0	0	1	1
Withdrew: Lost to follow-up	0	1	0	00
Withdrew: Death	0	1	0	0

Outcome measures

PrimaryNumber 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

Time frame:: Baseline and Week 8
Reported as:: Count of participants · Participants

Number of Subjects Reaching Investigator's Global Assessment (IGA) Success - Seborrheic Dermatitis (SD)
Participants	Sebderm PF-07038124	Sebderm Placebo
Number of Subjects Reaching Investigator's Global Assessment (IGA) Success - Seborrheic Dermatitis (SD)	8	1

PrimaryPercent Change in Lesion Count Papulopustular Rosacea (PPR)

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

Time frame:: Baseline and Week 8
Reported as:: Mean · percent change

Percent Change in Lesion Count Papulopustular Rosacea (PPR)
percent change	Papulopustular Rosacea PF-07038124	Papulopustular Rosacea Placebo
Percent Change in Lesion Count Papulopustular Rosacea (PPR)	-13 ± 30	-56 ± 27

SecondaryChange 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.

Time frame:: Baseline and 8 weeks
Reported as:: Mean · score on a scale

Change in SD Severity Score at 8 Weeks
score on a scale	Sebderm PF-07038124	Sebderm Placebo
Overall	-6 ± 2	-4 ± 2
Pruritus	-2 ± 1	-1 ± 1
Erythema	-2 ± 1	-1 ± 0
Scaling	-2 ± 1	-1 ± 1

SecondaryNumber 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

Time frame:: Baseline and 8 weeks
Reported as:: Count of participants · Participants

Number of Patients With Treatment Success Via IGA in PPR
Participants	Papulopustular Rosacea PF-07038124	Papulopustular Rosacea Placebo
Number of Patients With Treatment Success Via IGA in PPR	0	1

SecondaryPercent 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

Time frame:: Baseline and 8 weeks
Reported as:: Mean · percent change in score on a scale

Percent Change in Clinical Erythema - PPR
percent change in score on a scale	Papulopustular Rosacea PF-07038124	Papulopustular Rosacea Placebo
Percent Change in Clinical Erythema - PPR	-8 ± 14	-22 ± 38

SecondaryChange 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

Time frame:: Baseline and 8 weeks
Reported as:: Mean · score on a scale

Change in Patient Assessment of Erythema - PPR
score on a scale	Papulopustular Rosacea PF-07038124	Papulopustular Rosacea Placebo
Change in Patient Assessment of Erythema - PPR	-0.29 ± 0.76	-0.67 ± 1.15

SecondaryChange in Lesion Count - PPR

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

Time frame:: Baseline, 8 weeks, 12 weeks
Reported as:: Mean · change in lesion count

Change in Lesion Count - PPR
change in lesion count	Papulopustular Rosacea PF-07038124	Papulopustular Rosacea Placebo
week 8 to week 12	0 ± 2	1 ± 6
baseline to week 12	-3 ± 6	-6 ± 5

SecondaryChange 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

Time frame:: Baseline and 8 weeks
Reported as:: Median · score on a scale

Change in IGA Score - SD and PPR
score on a scale	Sebderm PF-07038124	Sebderm Placebo	Rosacea PF-07038124	Rosacea Placebo
Baseline	3 (3 to 3)	3 (3 to 4)	3 (3 to 4)	3 (3 to 3)
Week 8	1 (1 to 3)	2 (2 to 3)	3 (3 to 3.5)	3 (2 to 3)

SecondaryPercent 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

Time frame:: Baseline and 8 weeks
Reported as:: Mean · percent change

Percent Change in IGA Score - SD and PPR
percent change	Sebderm PF-07038124	Sebderm Placebo	Rosacea PF-07038124	Rosacea Placebo
Percent Change in IGA Score - SD and PPR	-53.2051 ± 9.2709	-33.3333 ± 12.0761	-8.3333 ± 5.4554	-22.2222 ± 22.2222

SecondaryChange 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

Time frame:: Baseline and Week 12
Reported as:: Median · score on a scale

Change in IGA Score - SD and PPR
score on a scale	Sebderm PF-07038124	Sebderm Placebo	Rosacea PF-07038124	Rosacea Placebo
Baseline	3 ± 7.0221	3 ± 13.7941	3 ± NA	3 ± 0.2113
Week 12	2 (1 to 2)	2 (1 to 3)	3 (3 to 4)	3 (2.5 to 3)

SecondaryChange 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.

Time frame:: Baseline and Week 8
Reported as:: Mean · score on a scale

Change in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Week 8
score on a scale	Sebderm PF-07038124	Sebderm Placebo	Rosacea PF-07038124	Rosacea Placebo
Change in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Week 8	-2.5833 ± 0.9249	-1.6 ± 1.5684	-1.1429 ± 0.6335	-0.6667 ± 0.6667

SecondaryNumber of Study Drug Related Adverse Events

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

Time frame:: 12 weeks
Reported as:: Number · Events

Number of Study Drug Related Adverse Events
Events	Sebderm PF-07038124	Sebderm Placebo	Rosacea PF-07038124	Rosacea Placebo
Number of Study Drug Related Adverse Events	0	1	1	0

SecondaryFrequency of Study Drug Related Adverse Events

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

Time frame:: 12 weeks
Reported as:: Number · events

Frequency of Study Drug Related Adverse Events
events	Sebderm PF-07038124	Sebderm Placebo	Rosacea PF-07038124	Rosacea Placebo
Frequency of Study Drug Related Adverse Events	0	1	1	0

SecondarySeverity of Adverse Events

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

Time frame:: 12 weeks
Reported as:: Number · Events

Severity of Adverse Events
Events	Sebderm Placebo	Rosacea PF-07038124	Rosacea Placebo
Mild	0	1	1
Moderate	1	1	0
Severe	0	0	0

Adverse events

Collected over 14 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Sebderm PF-07038124	0/13 (0%)	0/13 (0%)	0/13 (0%)
Sebderm Placebo	1/7 (14.3%)	0/7 (0%)	1/7 (14.3%)
Rosacea PF-07038124	0/8 (0%)	0/8 (0%)	2/8 (25%)
Rosacea Placebo	0/4 (0%)	0/4 (0%)	1/4 (25%)

Most frequent other events

Most frequent other events
Event	Sebderm PF-07038124	Sebderm Placebo	Rosacea PF-07038124	Rosacea Placebo
Urinary Tract Infection (UTI)Infections and infestations	0/13	0/7	0/8	1/4
Facial IrritationSkin and subcutaneous tissue disorders	0/13	1/7	0/8	0/4
Acute Otitis MediaEar and labyrinth disorders	0/13	0/7	1/8	0/4
NasopharyngitisInfections and infestations	0/13	0/7	1/8	0/4

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Sebderm PF-07038124	Sebderm Placebo	Rosacea PF-07038124	Rosacea Placebo	Total
Mean	52 ± 15	38 ± 16	48 ± 13	43 ± 9	48 ± 16

Sex: Female, Male
Sex: Female, Male(Participants)	Sebderm PF-07038124	Sebderm Placebo	Rosacea PF-07038124	Rosacea Placebo	Total
Female	4	3	3	2	12
Male	9	4	5	2	20

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Sebderm PF-07038124	Sebderm Placebo	Rosacea PF-07038124	Rosacea Placebo	Total
Hispanic or Latino	6	1	5	2	14
Not Hispanic or Latino	7	6	3	2	18
Unknown or Not Reported	0	0	0	0	0

Sebderm IGA
Sebderm IGA(Participants)	Sebderm PF-07038124	Sebderm Placebo	Rosacea PF-07038124	Rosacea Placebo	Total
IGA Score of 3	10	2	—	—	12
IGA Score of 4	3	5	—	—	8

SD Severity
SD Severity(units on a scale)	Sebderm PF-07038124	Sebderm Placebo	Rosacea PF-07038124	Rosacea Placebo	Total
Scaling	2 ± 1	3 ± 1	—	—	3 ± 1
Erythema	3 ± 0	3 ± 1	—	—	3 ± 1
Pruritus	2 ± 1	3 ± 1	—	—	2 ± 1
Total	8 ± 1	9 ± 2	—	—	8 ± 1

PPR Inflammatory Lesion Count
PPR Inflammatory Lesion Count(lesions)	Sebderm PF-07038124	Sebderm Placebo	Rosacea PF-07038124	Rosacea Placebo	Total
Mean	—	—	21 ± 8	16 ± 3	19 ± 7

PPR IGA Score
PPR IGA Score(Participants)	Sebderm PF-07038124	Sebderm Placebo	Rosacea PF-07038124	Rosacea Placebo	Total
IGA Score of 3	—	—	5	4	9
IGA Score of 4	—	—	3	0	3

Number of Participants with PPR Clinical Patient Erythema Assessment Score 3 or 4
Number of Participants with PPR Clinical Patient Erythema Assessment Score 3 or 4(Participants)	Sebderm PF-07038124	Sebderm Placebo	Rosacea PF-07038124	Rosacea Placebo	Total
Score of 3	—	—	6	4	10
Score of 4	—	—	2	0	2

1 further baseline measures are reported on the registry.

Study locations

1 site

Icahn School of Medicine at Mount Sinai
New York, New York 10029, United States

References and documents

Study documents

Protocol and statistical analysis plan · May 30, 2023
Informed consent form · May 28, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — Data will be analyzed as aggregated data

Registry details

Key details

Study ID: NCT06013371
Lead sponsor: Icahn School of Medicine at Mount Sinai
Collaborators: Pfizer
Responsible party: Benjamin Ungar (Assistant Professor, Icahn School of Medicine at Mount Sinai) — Principal investigator
First posted: Aug 28, 2023
Start date: Jul 19, 2023
Primary completion: Feb 18, 2025
Completion: Feb 18, 2025
Results posted: Aug 14, 2026
Last update: Aug 14, 2026

Study contacts

Benjamin Ungar, MD

principal investigator · Icahn School of Medicine at Mount Sinai

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

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