Study of TP-04 in Participants With Papulopustular Rosacea

Papulopustular Rosacea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05838170
• Other study ID #: TRS-016
• Status: Completed
• Phase: Phase 2
• Start date: March 1, 2023
• Est. completion date: November 13, 2023

Study information

• Verified date: November 2023
• Source: Tarsus Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: November 13, 2023
• Est. primary completion date: November 13, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

Inclusion criteria:

1. Participant is willing to participate and is capable of giving informed consent. Note:

Consent must be obtained prior to any study-related procedures.

2. Male or female participant aged 18 to 59 years, inclusive, at the time of consent.

3. 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).

4. 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.

5. 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.

6. 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.

7. Participant has SSSB1 > 5 D/cm² or SSSB2 > 10 D/cm² at the screening and Day 1 visits.

8. Female participant of childbearing potential has had a negative serum pregnancy test at screening and a negative urine pregnancy test at Day 1.

9. 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.

10. 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.

11. 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.

12. 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.

13. Participants must be willing to comply with all study procedures and must be available for the duration of the study.

Exclusion criteria:

1. Participant is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.

2. 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.

3. 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.

4. 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.

5. 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.

6. Participant has a known history of chronic infectious disease (eg, hepatitis B, hepatitis C, or human immunodeficiency virus [HIV]).

7. 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.

8. Participant has received any marketed or investigational biological agent within 12 weeks or 5 half-lives (whichever is longer) prior to Day 1.

9. 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.

10. Participant has received photodynamic therapy, phototherapy with blue or red light, or laser therapy to the face within 8 weeks prior to Day 1.

11. Participant had a major surgery within 8 weeks prior to Day 1 or has a major surgery planned during the study.

12. Participant has used systemic immunosuppressants (eg, steroids, steroid injections, cyclosporine, methotrexate, mycophenolate mofetate) within 8 weeks prior to Day 1.

13. Participant had a facial procedure (eg, chemical peel, microdermabrasion) within 8 weeks prior to Day 1.

14. Participant has used systemic products that could affect PPR within 4 weeks prior to Day 1 (eg, oral antibiotics, ivermectin).

15. Participant is currently receiving a nonbiological investigational product or device or has received one within 4 weeks prior to Day 1.

16. 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.

17. 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.

18. 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).

19. 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, a-hydroxy/glycolic, or antibacterial/antiseptic soap or wash within 2 weeks prior to Day 1.

20. Participant has a known or suspected allergy to Lotilaner Gel, 2.0% (TP-04) or any component of the investigational product.

Related Conditions & MeSH terms

• Papulopustular Rosacea
• Rosacea

Intervention

Drug:
• Lotilaner Gel, 2.0%
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).

Other:
• Vehicle control gel
Aqueous gel

Locations

Country	Name	City	State
Canada	Innovaderm Research Inc.	Montréal	Quebec
Canada	The Centre for Clinical Trials	Oakville	Ontario
Canada	SKiN Centre for Dermatology	Peterborough	Ontario
Canada	Centre de Recherche Saint-Louis	Québec
Canada	K. Papp Clinical Research	Waterloo	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Tarsus Pharmaceuticals, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Week 1 through Week 12
Primary	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	Week 1 through Week 12
Primary	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	Week 1 through Week 12
Primary	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	Week 1 through Week 12
Primary	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	Week 1 through Week 12
Primary	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	Week 1 through Week 12
Primary	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	Week 1 through Week 12
Primary	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	Week 1 through Week 12
Primary	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	Week 1 through Week 12
Primary	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	Week 1 through Week 12
Primary	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	Week 1 through Week 12
Primary	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	Week 1 through Week 12
Primary	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	Week 1 through Week 12
Secondary	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)	Week 1 through Week 12
Secondary	Facial Inflammatory lesion counts - absolute change from baseline	Absolute change from baseline in facial inflammatory lesion counts	Week 1 through Week 12
Secondary	Facial inflammatory lesion counts - percent change from baseline	Percent change from baseline in facial inflammatory lesion counts	Week 1 through Week 12
Secondary	Investigator Global Assessmen (IGA) Score (0=clear; 4=severe) - absolute change from baseline	Absolute change from baseline in IGA score	Week 1 through Week 12
Secondary	Clinician Erythema Assessment (CEA) Score (0=clear; 4=severe) - absolute change from baseline	Absolute change from baseline in CEA score	Week 1 through Week 12
Secondary	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	Week 1 through Week 12
Secondary	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	Week 1 through Week 12
Secondary	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)	Week 1 through Week 12