Study of TP-04 in Participants With Papulopustular Rosacea (NCT05838170) | Clinical Trial Compass
CompletedPhase 2
Study of TP-04 in Participants With Papulopustular Rosacea
Canada37 participantsStarted 2023-03-01
Plain-language summary
This study is being done to evaluate the safety, tolerability, and efficacy of the study drug, TP-04, in participants with papulopustular rosacea (PPR).
Who can participate
Age range
18 Years – 59 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participant is willing to participate and is capable of giving informed consent. Note: Consent must be obtained prior to any study-related procedures.
. Male or female participant aged 18 to 59 years, inclusive, at the time of consent.
. Participant has at least a 6-month history of PPR at the screening visit (information obtained from medical chart or participant's physician, or directly from the participant).
. Participant has moderate or severe PPR, as defined by an IGA score of 3 (moderate) or 4 (severe) at the screening and Day 1 visits.
. Participant has 20 to 70 inflammatory lesions (papules and/or pustules) and no more than 2 nodules (defined as a lesion ˃ 5 mm in diameter) on the face at the screening and Day 1 visits.
. Participant has moderate or severe persistent erythema associated with PPR, as defined by a CEA score of 3 (moderate) or 4 (severe) at the screening and Day 1 visits.
. Participant has SSSB1 \> 5 D/cm² or SSSB2 \> 10 D/cm² at the screening and Day 1 visits.
. Female participant of childbearing potential has had a negative serum pregnancy test at screening and a negative urine pregnancy test at Day 1.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The incidence of treatment emergent adverse events from baseline
Timeframe: Week 1 through Week 12
2
Changes from baseline in vital signs change in height in cm
Timeframe: Week 1 through Week 12
3
Changes from baseline in vital signs change in weight in kg
Timeframe: Week 1 through Week 12
4
Changes from baseline in vtial signs change in systolic/diastolic blood pressure in mmHg
Timeframe: Week 1 through Week 12
5
Changes from baseline in vital signs change in pulse in beats per minute
Timeframe: Week 1 through Week 12
6
Changes from baseline in vital signs change in respiratory rate in breaths per minute
Timeframe: Week 1 through Week 12
7
Changes from baseline in vital signs change in temperature in Celsius
. Participant is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
. Participant has rosacea conglobata, rosacea fulminans, perioral dermatitis, facial erythrosis other than rosacea, corticosteroid-induced rosacea, facial keratosis pilaris, facial seborrheic dermatitis, acute lupus erythematosus, chronic recurring facial acne vulgaris, isolated rhinophyma, or plaque- like facial edema or with ocular rosacea (blepharitis, keratitis) requiring or likely to require systemic treatment.
. Participant has a history of skin disease, presence of a skin condition, scarring, excessive facial hair, tattoos, or other facial characteristics (eg, actinic damage) that could, in the opinion of the investigator, interfere with study assessments.
. Participant has any clinically significant medical condition or physical/laboratory/ECG/vital signs abnormality that would, in the opinion of the investigator, put the participant at undue risk or interfere with interpretation of study results.
. Participant has a history of cancer or lymphoproliferative disease within 5 years prior to Day 1. Participants with successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix are not to be excluded.
. Participant has a known history of chronic infectious disease (eg, hepatitis B, hepatitis C, or human immunodeficiency virus \[HIV\]).
. Participant has used oral retinoids (eg, isotretinoin) within 52 weeks prior to Day 1 or high-dose vitamin A (\> 10,000 IU/day) within 26 weeks prior to Day 1.
. Participant has received any marketed or investigational biological agent within 12 weeks or 5 half-lives (whichever is longer) prior to Day 1.
8
Change from baseline in ECGs change in QRS interval in msec
Timeframe: Week 1 through Week 12
9
Changes from baseline in ECGs change in mean ventricular rate (beats/min)
Timeframe: Week 1 through Week 12
10
Changes in baseline in ECGs change in QTC interval in msec
Timeframe: Week 1 through Week 12
11
Changes in clinical chemistry laboratory assessments from baseline
Timeframe: Week 1 through Week 12
12
Changes in hematology laboratory assessments from baseline
Timeframe: Week 1 through Week 12
13
Local tolerability assessment ((0=none, 3=severe): dryness, scaling, erythema, burning/stinging; itching)