A Phase 2 interventional study of Brimonidine gel and No intervantion in Chemotherapy Induced Peripheral Neuropathy, sponsored by Tarian Pharma. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-24.
Sponsored by Tarian Pharma · Phase 2, Interventional, and Prevention
Taxane -induced peripheral neuropthy (TIPN) and nail toxicites are frequent side effects of taxane therapy in breast cancer patients.. TIPN involves the hands and the feet ,its symptoms comprise numbness,tingling,altered touch sensation, impaired vibration, parasthesia and dysesthesias induced by touch, warm or cool temperatures.
This study investigate the preventive effect of TAR-0520 gel on TIPN and on nail toxicity.
Breast cancer patients under taxanes therapy will apply TAR-0520 Gel to one hand and the homolateral foot including fingers and toes. Other hand and foot will be untreated and will serve as control.
Patients will be followed during the 12 cycles of taxane therapy. Evaluations of TIPN will include clinical assessments by the oncologist, examination by a neurologist, patient questionnaires administered by a nurse and objective neurophysiological measures conducted by trained personnel. Evaluation of taxane nail toxicity will include a clinical grading by a nurse and a patient questionnaire.
This is a Phase 2a, open label, intra-individual study with approximately 30 patients included.
Principal objective of the study is to confirm the local and systemic safety of TAR-0520 Gel applied twice daily to one hand and one foot, in breast cancer patients treated with taxanes.
Secondary objectives of the study are:
Each patient will receive the active drug candidate TAR-0520 gel for 3 days at each taxane cycle (usually 12 cycles with an infusion every week). During these 3 days, TAR-0520 gel will be applied to one hand and one foot, twice daily, starting the day of taxane infusion and continuing the next two days (thus covering the period when Paclitaxel will be circulating: elimination half-life of the drug is approximately 24 hours).
TAR-0520 gel will be applied by the patients themselves using their dominant hand wearing a glove, patients will apply TAR-0520 gel to the contro-lateral hand and foot. Test product is to be applied to both palmo-plantar and dorsal areas of hand and foot including fingers/toes and the skin surrounding nails. No product is to be applied to the hand and foot on the other side (dominant hand side).
Patients will be included one week before the taxane treatment initiation and followed during the 12 taxane cycles as well as 12 weeks later (follow-up visit). Evaluations of TIPN will include clinical assessments by the oncologist, examination by a neurologist, patient questionnaire administered by a nurse and objective neurophysiological measures conducted by trained personnel. Evaluation of nail toxicities will include clinical grading by a nurse and a patient questionnaire.
The study will include 17 visits: a Screening visit, 15 evaluations visits and a follow-up visit (Final assessment) that will occur approximately 12 weeks after the last taxane infusion.
Evaluations visits will be conducted one week before the first taxane infusion, the days of taxane infusions, between the 6th and the 7th cycle of taxane infusion, one week after the last taxane infusion and at a follow-up visit, 3 months after the last taxane infusion. This design will allow to assess TIPN progression during treatment as well as persistent TIPN following treatment discontinuation.
Tarian Pharma is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Tar-0520 gel will be applied to one hand and to homolateral foot ,other hand and foot will be not treated and will serve as control
Drug: Brimonidine gel · Other: No intervantion
TAR-0520 gel
No treatment
Number of treatment related local adverse events
Treatement related local adverse events inluding erythema, oedema, pruritus
Time frame: From Baseline up to the end of 12 taxane perfusions
CTCAE grade of peripheral neuropathy
CTCAE V5.0 Nervous system disorders grading ( Grade 0-5, 0-asymptomatic, 5- death)
Time frame: From Baseline up to the end of 12 taxane perfusions
Instrumental objective measures of TIPN - heat thresold
Quantitative sensory testing - heat thresold measurement at each hand and feet
Time frame: At Baseline and after 6th and 12th taxane perfusion
Instrumental objective measures of TIPN - cold thresold
Quantitative sensory testing - cold thresold measure on each hand and feet
Time frame: At Baseline and after 6th and 12th perfusions
Instrumental objective measures of TIPN - vibration treshold
Quanitative sensory testing - vibration treshold
Time frame: At Baseline and after 6th and 12th perfusion
Instrumental objective meeasures of TIPN - electrochemical skin conductance (ESC)
Quantitative skin conductance testing - skin conductance measurements at each hand and feet
Time frame: At Baseline and after 6th and 12 perfusion
Nail toxicity grading
Nail toxicity grading at each hand and foot : nail discoloration; nail riding; nail onycholysis - each graded as absent, mild, moderate or severe.
Time frame: At Baseline and before 4th and 12th perfusion
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2025; primary completion for Sep 2026, 12 months later.
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Studies of the drug tested here: Brimonidine
Tarian Pharma