Papulopustular RosaceaPhase 2NCT05838170
Study of TP-04 in Participants With Papulopustular Rosacea
A Phase 2 study testing Lotilaner Gel, 2.0% in people with Papulopustular Rosacea, run by Tarsus Pharmaceuticals, Inc. at 5 sites in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Papulopustular Rosacea
- What is being tested?
- Lotilaner Gel, 2.0%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 5 sitesCanada
- Study dates
- 1 Mar 2023to 13 Nov 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
- For female participant of childbearing potential involved in any sexual intercourse that could lead to pregnancy: the participant must agree to use a highly effective contraceptive method from at least 4 weeks prior to Day 1 until at least 6 months after the last study product application. Highly effective contraceptive methods include hormonal contraceptives (eg, combined oral contraceptive, patch, vaginal ring, injectable, or implant), intrauterine devices or intrauterine systems, vasectomized partner(s) (provided his vasectomy was performed ≥ 4 months prior to screening), tubal ligation or double barrier methods of contraception (eg, male condom with cervical cap, male condom with diaphragm, and male condom with contraceptive sponge) in conjunction with spermicide.
- For male participant involved in any sexual intercourse that could lead to pregnancy, participant must agree to use one of the highly effective contraceptive methods listed in Inclusion Criterion #9, from Day 1 until at least 6 months after the last study product application. If the female partner of a male participant use any of the hormonal contraceptive methods listed above, this contraceptive method should be used by the female partner from at least 4 weeks before Day 1 until at least 6 months after the last study product application.
- For participant who uses makeup, facial moisturizers, creams, lotions, cleansers, and/or sunscreens, participant has used the same product brands/types for a minimum period of 2 weeks prior to Day 1, agrees not to change brand/type or frequency of use throughout the study, and agrees not to use makeup, facial moisturizers, creams, lotions, cleansers, and/or sunscreens prior to study visits. Participants will be instructed not to apply these products on the treated areas within approximately 30 minutes before and after study product application.
- Participant is willing to limit or avoid known personal triggers of rosacea (eg, spicy foods, consumption of alcoholic beverages, extended intentional sun exposure, tanning beds, sauna, etc) for the duration of the study.
- Participants must be willing to comply with all study procedures and must be available for the duration of the study.
Who cannot join
- 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]).
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- 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.
- Participant has received hormonal therapy that is not on a stable dose and frequency for at least 12 weeks before Day 1 or that is not maintained throughout the study.
- Participant has received photodynamic therapy, phototherapy with blue or red light, or laser therapy to the face within 8 weeks prior to Day 1.
- Participant had a major surgery within 8 weeks prior to Day 1 or has a major surgery planned during the study.
- Participant has used systemic immunosuppressants (eg, steroids, steroid injections, cyclosporine, methotrexate, mycophenolate mofetate) within 8 weeks prior to Day 1.
- Participant had a facial procedure (eg, chemical peel, microdermabrasion) within 8 weeks prior to Day 1.
- Participant has used systemic products that could affect PPR within 4 weeks prior to Day 1 (eg, oral antibiotics, ivermectin).
- Participant is currently receiving a nonbiological investigational product or device or has received one within 4 weeks prior to Day 1.
- Participant has used any narrow therapeutic index (NTI) drug metabolized by cytochrome P450 (CYP)2C8, CYP2C19, CYP2C9, or CYP2D6 within 4 weeks prior to Day 1 or may require using any NTI drug metabolized by CYP2C8, CYP2C19, CYP2C9, or CYP2D6 within 8 weeks after the last study product application.
- Participant is exposed to excessive sunlight (eg, working outside), is planning a trip to a sunny climate, or has used tanning booths within 4 weeks prior to Day 1 or is not willing to minimize exposure to natural and artificial sunlight or weather extremes (wind or cold) during the study.
- Participant has used topical products that could affect PPR within 2 weeks prior to Day 1 (eg, metronidazole, azealeic acid, topical minocycline, sulfacetamide, resorcinol, clindamycin, topical ivermectin, tea tree oil, dapsone, cannabidiol [CBD]-containing products, topical calcineurin inhibitors, benzyl peroxide, topical retinoid/retinol, alpha or beta hydroxy-acids, phosphodiesterase 4 [PDE4] inhibitors, topical Janus kinase [JAK] inhibitors, oxymetazoline, bromonidine).
- Participant has used on the face an over-the-counter (OTC) or prescription topical medication for rosacea, including benzoyl peroxide, topical anti-inflammatory medications, corticosteroids, salicylic acid, α-hydroxy/glycolic, or antibacterial/antiseptic soap or wash within 2 weeks prior to Day 1.
- Participant has a known or suspected allergy to Lotilaner Gel, 2.0% (TP-04) or any component of the investigational product.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Innovaderm Research Inc.
Montreal, Quebec, H2X 2V1
The Centre for Clinical Trials
Oakville, Ontario, L6J 7W5
SKiN Centre for Dermatology
Peterborough, Ontario, K9J 5K2
Centre de Recherche Saint-Louis
Québec, G1W4R4
K. Papp Clinical Research
Waterloo, Ontario, N2J 1C4
About this study
Official title: A Phase 2, Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety, Tolerability, and Efficacy of TP-04 in Participants With Papulopustular Rosacea
This study is being done to evaluate the safety, tolerability, and efficacy of the study drug, TP-04, in participants with papulopustular rosacea (PPR).
Read the detailed description
This is a Phase 2, multicenter, randomized, double-blind, parallel-group, vehicle-controlled study evaluating the safety, tolerability, and efficacy of Lotilaner Gel, 2.0% (TP-04) applied BID for 12 weeks in participants with moderate to severe PPR.
- Conditions
- Papulopustular Rosacea
- Being tested
- Lotilaner Gel, 2.0%, Vehicle control gel
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lotilaner Gel, 2.0%Drug
Also called TP-04
Lotilaner Gel, 2.0% (TP-04) is an aqueous gel formulation of lotilaner, a member of the isoxazoline family of compounds and parasiticide that selectively inhibits parasite-specific gamma-aminobutyric acid (GABA)-gated chloride channels (GABA-Cls).
Vehicle control gelOther
Also called Vehicle Gel
Aqueous gel
| Study group | Role | What they receive |
|---|---|---|
| Lotilaner Gel, 2.0% (TP-04) | Experimental | Participants will be randomized to a 2:1 ratio at baseline to apply Lotilaner Gel, 2.0% (TP-04) on the face BID for 12 weeks. Receives: Drug: Lotilaner Gel, 2.0% |
| Vehicle-Controlled | Placebo comparator | Participants will be randomized to a 2:1 ratio at baseline to apply vehicle control gel on the face BID for 12 weeks. Receives: Other: Vehicle control gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of treatment emergent adverse events from baseline
Incidence of local and systemic TEAEs while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel from baseline
Measured: Week 1 through Week 12
Changes from baseline in vital signs change in height in cm
Changes from baseline in vital signs change in height in cm while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
Measured: Week 1 through Week 12
Changes from baseline in vital signs change in weight in kg
Changes from baseline in vital signs change in weight in kg while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
Measured: Week 1 through Week 12
Changes from baseline in vtial signs change in systolic/diastolic blood pressure in mmHg
Changes from baseline in vital signs change in systolic/diastolic blood pressure in mmHg while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
Measured: Week 1 through Week 12
Changes from baseline in vital signs change in pulse in beats per minute
Changes from baseline in vital signs change in pulse in beats per minute while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
Measured: Week 1 through Week 12
Changes from baseline in vital signs change in respiratory rate in breaths per minute
Changes from baseline in vital signs change in respiratory rate in breaths per minute while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
Measured: Week 1 through Week 12
Changes from baseline in vital signs change in temperature in Celsius
Changes from baseline in vital signs change in temperature in Celsius while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
Measured: Week 1 through Week 12
Change from baseline in ECGs change in QRS interval in msec
Changes from baseline in ECGs change in QRS interval in msec while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
Measured: Week 1 through Week 12
Changes from baseline in ECGs change in mean ventricular rate (beats/min)
Changes from baseline in ECGs change in mean ventricular rate (beats/min) while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
Measured: Week 1 through Week 12
Changes in baseline in ECGs change in QTC interval in msec
Changes from baseline in ECGs change in QTC interval in msec while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
Measured: Week 1 through Week 12
Changes in clinical chemistry laboratory assessments from baseline
Changes from baseline clinical chemistry laboratory values while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
Measured: Week 1 through Week 12
Changes in hematology laboratory assessments from baseline
Changes from baseline hematology laboratory values while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
Measured: Week 1 through Week 12
Local tolerability assessment ((0=none, 3=severe): dryness, scaling, erythema, burning/stinging; itching)
Evaluate local tolerability assessment ((0=none, 3=severe): dryness, scaling, erythema, burning/stinging; itching) of Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
Measured: Week 1 through Week 12
Secondary outcomes (8)
Improvement in Investigator Global Assessment (IGA) score (0=clear; 4=severe)
Proportion (%) of participants achieving ≥ 2-point improvement in IGA score to clear (0) or almost clear (1)
Measured: Week 1 through Week 12
Facial Inflammatory lesion counts - absolute change from baseline
Absolute change from baseline in facial inflammatory lesion counts
Measured: Week 1 through Week 12
Facial inflammatory lesion counts - percent change from baseline
Percent change from baseline in facial inflammatory lesion counts
Measured: Week 1 through Week 12
Investigator Global Assessmen (IGA) Score (0=clear; 4=severe) - absolute change from baseline
Absolute change from baseline in IGA score
Measured: Week 1 through Week 12
Clinician Erythema Assessment (CEA) Score (0=clear; 4=severe) - absolute change from baseline
Absolute change from baseline in CEA score
Measured: Week 1 through Week 12
Pruritus Numeric Rating Scale (NRS) Score (0=no itch; 10= worst imaginable itch) - absolute change from baseline
Absolute change from baseline in worst pruritus NRS score
Measured: Week 1 through Week 12
Worst Pain Numeric Rating Scale (NRS) Score (0=no pain; 10= worst imaginable pain) - absolute change from baseline
Absolute change from baseline in worst pain NRS score
Measured: Week 1 through Week 12
Improvement in Worst Pruritus Numeric Rating Scale (NRS) Score (0=no itch; 10= worst imaginable itch)
Proportion (%) of participants achieving at least a 4-point reduction in worst pruritus NRS score (0= no itch; 10= worst imaginable itch)
Measured: Week 1 through Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start1 Mar 2023
- Primary completion13 Nov 2023
- Study completion13 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papulopustular RosaceaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The investigational product (Lotilaner Gel, 2.0% \[TP-04\]) or vehicle control gel will be applied topically on the face twice daily (BID) during the study. Participants will be randomized to a 2:1 ratio at baseline to apply Lotilaner Gel, 2.0% (TP-04) or vehicle control gel on the face BID for 12 weeks.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tarsus Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jose Trevejo, MD, PhD, Study director, Tarsus Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05838170
- Sponsor's protocol ID
- TRS-016
- Status last verified
- Nov 2023
- First submitted
- 13 Mar 2023
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety, Tolerability, and Efficacy of TP-04 in Participants With Papulopustular Rosacea
- ClinicalTrials.gov ID
- NCT05838170
- Acronym / sponsor ID
- TRS-016
- Conditions
- Papulopustular Rosacea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Tarsus Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 13 Nov 2023 (actual)
- Study completion
- 13 Nov 2023 (actual)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to evaluate the safety, tolerability, and efficacy of the study drug, TP-04, in participants with papulopustular rosacea (PPR).
Detailed description
This is a Phase 2, multicenter, randomized, double-blind, parallel-group, vehicle-controlled study evaluating the safety, tolerability, and efficacy of Lotilaner Gel, 2.0% (TP-04) applied BID for 12 weeks in participants with moderate to severe PPR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The investigational product (Lotilaner Gel, 2.0% [TP-04]) or vehicle control gel will be applied topically on the face twice daily (BID) during the study. Participants will be randomized to a 2:1 ratio at baseline to apply Lotilaner Gel, 2.0% (TP-04) or vehicle control gel on the face BID for 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| Lotilaner Gel, 2.0% (TP-04) | Experimental | Drug: Lotilaner Gel, 2.0%Participants will be randomized to a 2:1 ratio at baseline to apply Lotilaner Gel, 2.0% (TP-04) on the face BID for 12 weeks. |
| Vehicle-Controlled | Placebo comparator | Other: Vehicle control gelParticipants will be randomized to a 2:1 ratio at baseline to apply vehicle control gel on the face BID for 12 weeks. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lotilaner Gel, 2.0%Also: TP-04Lotilaner Gel, 2.0% (TP-04) is an aqueous gel formulation of lotilaner, a member of the isoxazoline family of compounds and parasiticide that selectively inhibits parasite-specific gamma-aminobutyric acid (GABA)-gated chloride channels (GABA-Cls). | Drug | Lotilaner Gel, 2.0% (TP-04) |
| Vehicle control gelAlso: Vehicle GelAqueous gel | Other | Vehicle-Controlled |
Primary outcome
The incidence of treatment emergent adverse events from baseline
Time frame: Week 1 through Week 12
Incidence of local and systemic TEAEs while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel from baseline
Changes from baseline in vital signs change in height in cm
Time frame: Week 1 through Week 12
Changes from baseline in vital signs change in height in cm while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
Changes from baseline in vital signs change in weight in kg
Time frame: Week 1 through Week 12
Changes from baseline in vital signs change in weight in kg while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
Changes from baseline in vtial signs change in systolic/diastolic blood pressure in mmHg
Time frame: Week 1 through Week 12
Changes from baseline in vital signs change in systolic/diastolic blood pressure in mmHg while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
Changes from baseline in vital signs change in pulse in beats per minute
Time frame: Week 1 through Week 12
Changes from baseline in vital signs change in pulse in beats per minute while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
Changes from baseline in vital signs change in respiratory rate in breaths per minute
Time frame: Week 1 through Week 12
Changes from baseline in vital signs change in respiratory rate in breaths per minute while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
Changes from baseline in vital signs change in temperature in Celsius
Time frame: Week 1 through Week 12
Changes from baseline in vital signs change in temperature in Celsius while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
Change from baseline in ECGs change in QRS interval in msec
Time frame: Week 1 through Week 12
Changes from baseline in ECGs change in QRS interval in msec while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
Changes from baseline in ECGs change in mean ventricular rate (beats/min)
Time frame: Week 1 through Week 12
Changes from baseline in ECGs change in mean ventricular rate (beats/min) while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
Changes in baseline in ECGs change in QTC interval in msec
Time frame: Week 1 through Week 12
Changes from baseline in ECGs change in QTC interval in msec while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
Changes in clinical chemistry laboratory assessments from baseline
Time frame: Week 1 through Week 12
Changes from baseline clinical chemistry laboratory values while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
Changes in hematology laboratory assessments from baseline
Time frame: Week 1 through Week 12
Changes from baseline hematology laboratory values while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
Local tolerability assessment ((0=none, 3=severe): dryness, scaling, erythema, burning/stinging; itching)
Time frame: Week 1 through Week 12
Evaluate local tolerability assessment ((0=none, 3=severe): dryness, scaling, erythema, burning/stinging; itching) of Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
8 secondary outcomes
Improvement in Investigator Global Assessment (IGA) score (0=clear; 4=severe)
Time frame: Week 1 through Week 12
Facial Inflammatory lesion counts - absolute change from baseline
Time frame: Week 1 through Week 12
Facial inflammatory lesion counts - percent change from baseline
Time frame: Week 1 through Week 12
Investigator Global Assessmen (IGA) Score (0=clear; 4=severe) - absolute change from baseline
Time frame: Week 1 through Week 12
Clinician Erythema Assessment (CEA) Score (0=clear; 4=severe) - absolute change from baseline
Time frame: Week 1 through Week 12
Pruritus Numeric Rating Scale (NRS) Score (0=no itch; 10= worst imaginable itch) - absolute change from baseline
Time frame: Week 1 through Week 12
Worst Pain Numeric Rating Scale (NRS) Score (0=no pain; 10= worst imaginable pain) - absolute change from baseline
Time frame: Week 1 through Week 12
Improvement in Worst Pruritus Numeric Rating Scale (NRS) Score (0=no itch; 10= worst imaginable itch)
Time frame: Week 1 through Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Trevejo, MD, PhD study director
Tarsus Pharmaceuticals, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lotilaner Gel, 2.0% in people with Papulopustular Rosacea, run by Tarsus Pharmaceuticals, Inc. at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of treatment emergent adverse events from baseline (time frame: Week 1 through Week 12). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.