Healthy participants Not Applicable
Conditions
Interventions
This is a monocentric, investigator-blinded, pharmacology study exploring the pharmacodynamic effect of two doses of TAR-0520 gel at 1.5% or 1% applied to two small skin areas (49 cm² each) on the che
Sponsors
Tarian Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject having signed an Informed Consent Form (ICF); 2. Male or female healthy subject with age = 18 and < 60 years at the time of signing the ICF; 3. Subject having a phototype II to IV; 4. For female subject of childbearing potential: Non-pregnant (*) and non-lactating female who is abstinent or agrees to use effective contraceptive methods throughout the course of the study; Acceptable birth control methods are the following: - Intrauterine device in place for at least 1 month, - Stable hormonal contraceptive for at least 1 month prior to dosing and continuing through study completion, - Surgically sterilized partner, - Male or female condom. (*) Female subject must have a negative urine beta-human chorionic gonadotropin hormone (hCG) pregnancy test prior to dosing. 5. Normally active and in good health by medical history and physical examination; 6. Subject able to comprehend the full nature and the purpose of the investigation, including possible risks and side effects, and subjects able to cooperate with the Investigator and to comply with the requirements of the entire investigation (including ability to attend all the planned investigation visits according to the time limits), based on Investigator’s judgement.
Exclusion criteria
Exclusion criteria: 1. Female who is pregnant or breastfeeding or who plans to become pregnant during the study; 2. Clinically significant allergy (as judged by the investigator) or history of significant adverse reaction to brimonidine or related compounds, or to any of the excipients used (Drug product composition provided in the IB); 3. Current diagnosis of Raynaud’s syndrome, thromboangiitis obliterans, orthostatic hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal or hepatic impairment, scleroderma, Sjögren’s syndrome, uncontrolled hypertension or diabetic microangiopathy; 4. Current treatment with brimonidine tartrate ophthalmic solution or gel; 5. Subject receiving monoamine oxidase (MAO) inhibitor therapy and subject on antidepressants which affect noradrenergic transmission (e.g., tricyclic antidepressants and mianserin); 6. Subject under a systemic treatment that might interfere with pharmacodynamic assessments such as beta-blockers, clonidine or calcium channel inhibitors (wash-out defined as 5 half-lives of the medication); 7. Subject with skin abnormalities (e.g. scars, excessive hair, tattooing) or any dermatosis (e.g. rosacea, seborrheic dermatitis, acne vulgaris) on the chest or the face; 8. Subject having been excessively exposed to ultraviolet radiation (UV), natural (sun) or artificial (tanning salon), in the 2 months before the initial visit or who plans such an exposure during the study; 9. Subject impossible to be contacted in case of emergency; 10. Subject currently participating or having participated in another clinical trial during the month preceding inclusion; 11. Subject who had been deprived of their freedom by administrative or legal decision or is under care of guardian or legal guardianship or subject hospitalized in a medical or social establishment for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacodynamic activity of TAR-0520 gel: 1. Skin blanching visual Score: Assessments will be done on the chest and the face minizones, 4 hours after products applications at Day 1, Day 3 and Day 5. 2. Chromametry: Chromametry assessments will be done on the chest and the face before products applications and 2 hours and 4 hours after products applications on Day 1, 3, 5, 19 and 23 or 26. In addition, chromametry assessments will be done on the chest and the face before products applications and 4 hours after products applications on Day 8, D12 and D15. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Local tolerance of TAR-0520 when applied to the face assessed visually at each visit on each test zone 2. A safety assessment will be conducted for all subjects at the screening visit (from the Informed consent signature) and every subsequent visit. The safety parameters in this study include AEs, physical examination, vital signs assessments and a local tolerance evaluation on treated minizones. | — |
Countries
Mauritius
Contacts
Public ContactOunisha Mungur
Outcome results
None listed