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 range18 Years – 59 Years
SexALL
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
✕. 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.
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
Timeframe: Week 1 through Week 12
8
Change from baseline in ECGs change in QRS interval in msec