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
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.
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.
58 studies on the registry are indexed under Dermatitis, Seborrheic; 7 are open to participants now.
This study's enrollment of 32 is below the median of 77 across 47 interventional studies indexed under Dermatitis, Seborrheic.
Browse Dermatitis, Seborrheic studies →Icahn School of Medicine at Mount Sinai is the lead sponsor of 776 studies on the registry; 176 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 83 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Females of (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 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:
The female subject's chosen form of contraception must be effective by the time the female subject is enrolled into the study.
Exclusion Criteria:
The presence of any of the following will exclude a subject from enrollment:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PF-07038124 0.02% ointment once daily for 8 weeks
Drug: PF-07038124
Placebo Ointment
Drug: Placebo Ointment
PF-07038124 0.02% ointment once daily for 8 weeks
Drug: PF-07038124
Placebo Ointment
Drug: Placebo Ointment
topical PDE4 inhibitor
matching placebo
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
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
| 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 |
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
| Participants | Sebderm PF-07038124 | Sebderm Placebo |
|---|---|---|
| Number of Subjects Reaching Investigator's Global Assessment (IGA) Success - Seborrheic Dermatitis (SD) | 8 | 1 |
Percent change from baseline in inflammation (papule/pustule) lesion count at 8 weeks
| percent change | Papulopustular Rosacea PF-07038124 | Papulopustular Rosacea Placebo |
|---|---|---|
| Percent Change in Lesion Count Papulopustular Rosacea (PPR) | -13 ± 30 | -56 ± 27 |
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.
| 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 |
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
| Participants | Papulopustular Rosacea PF-07038124 | Papulopustular Rosacea Placebo |
|---|---|---|
| Number of Patients With Treatment Success Via IGA in PPR | 0 | 1 |
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
| percent change in score on a scale | Papulopustular Rosacea PF-07038124 | Papulopustular Rosacea Placebo |
|---|---|---|
| Percent Change in Clinical Erythema - PPR | -8 ± 14 | -22 ± 38 |
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
| 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 |
Change from baseline and from 8 weeks in inflammatory (papule/pustule) lesion count at 12 weeks
| 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 |
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
| 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) |
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
| 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 |
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
| 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) |
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.
| 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 |
Number of adverse events reported throughout the study that are deemed related to study drug.
| Events | Sebderm PF-07038124 | Sebderm Placebo | Rosacea PF-07038124 | Rosacea Placebo |
|---|---|---|---|---|
| Number of Study Drug Related Adverse Events | 0 | 1 | 1 | 0 |
The frequency at which adverse events that are deemed related to study drug are reported throughout the study.
| events | Sebderm PF-07038124 | Sebderm Placebo | Rosacea PF-07038124 | Rosacea Placebo |
|---|---|---|---|---|
| Frequency of Study Drug Related Adverse Events | 0 | 1 | 1 | 0 |
Severity will be measured as a category (mild, Moderate, severe) according to CTCAE 5.0.
| Events | Sebderm PF-07038124 | Sebderm Placebo | Rosacea PF-07038124 | Rosacea Placebo |
|---|---|---|---|---|
| Mild | 0 | 0 | 1 | 1 |
| Moderate | 0 | 1 | 1 | 0 |
| Severe | 0 | 0 | 0 | 0 |
Collected over 14 weeks. Non-serious events are listed at a 0% frequency threshold.
| 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%) |
| 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 |
| 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(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)(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(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(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(lesions) | Sebderm PF-07038124 | Sebderm Placebo | Rosacea PF-07038124 | Rosacea Placebo | Total |
|---|---|---|---|---|---|
| Mean | — | — | 21 ± 8 | 16 ± 3 | 19 ± 7 |
| 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(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.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Data will be analyzed as aggregated data
This study is terminated, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: PF-07038124
Icahn School of Medicine at Mount Sinai →