EGFR Inhibitor-associated RashPhase 2NCT06818058
TAR-0520 Gel in EGFR Inhibitor-induced Folliculitis
A Phase 2 study testing Brimonidine tartrate Gel in people with EGFR Inhibitor-associated Rash, run by Tarian Pharma at 3 sites in France.
Trial summary
A Phase II, multicentric, randomized, double-blind, placebo-controlled, parallel- group trial to confirm the good safaty profile and to explore the preventive effect of topically applied TAR-0520 gel on folliculitis developed in metastatic colorectal cancer (mCRC) patients treated with monoclonal anti-EGFR antibodies. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- EGFR Inhibitor-associated Rash
- What is being tested?
- Brimonidine tartrate Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 3 sitesFrance
- Study dates
- 20 Jan 2025to 30 Sep 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or female, who is at least 18 years of age or older at the screening visit
- patients with clinical diagnosis of metastatic colorectal carcinoma planned to be treated with cetuximab or panitumumab injections as part of the chemotherapy protocol
- patients who can understand and sign the Informed Consent Form, can communicate with investigator,can understand and comply with requierements of the protocol, and can apply the study gel by himself/herself or have giver who can apply the product
- patients with predicted life expectency of > 3 months
- patients willing and able to comply with all of the time commitements and procedural requirements of the clinical trial protocol
Who cannot join
- patients with medical history of EGFR treatment in the past 2 years
- patients with any underlying physical ,psychological or medical condition that, in the opinion of the invstigator, would make it unlikely that the patient will comply with the protocol or complete the study protocol
- patients with any uncotrolled or serious disease, or any medical or surgical condition,that may put the subject at significant risk (according to the investigator's judgement) if he/she participates in the clinical trial
- patients with history of other skin disorders (eg.atopic dermatitis,psoriasis,recurrent skin infections), or a history of illness that, in the opinion of the investigator, would confound the results of the study
- patients with significant skin disease other than EGFRi-induced folliculits within the same body areas planned for study drug application
- patients with a beard that would interfere with administration of the study drug and assessement of study endpoints
Show all 9Show fewer
- patients with active infection within the treatment area ot in other body areas that requieres initiation of systemic antibiotics
- patients with known or suspected allergies or sensitivities to any components of the study drugs
- female patients who are pregnant or lactating
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Alexandra Lamquin, PhD contact
France3 sites, 3 recruiting
- Recruiting
Hopital Privé Jean Mermoz
Lyon, 69008
Pascal Artru, MD, +33437538726, dr.artru@wanadoo.fr
Pascal Artru, MD
- Recruiting
Institut Paoli Calmette
Marseille, 13273
Emmanuel Mitry, MD, +33 491223302, mitryje@ipc@unicancer.fr
Emmanuel Mitry, MD
- Not yet recruiting
Centre Antoine Lacassagne
Nice, 06189
Ludovic Evesque, MD, +33 492031352, ludovic.evesque@nice.unicancer.fr
Ludovic Evesque, MD
About this study
Official title: A Phase II Multicentric, Randomized, Double-blind, Placebo-controlled Study of TAR-0520 Gel in EGFR Inhibitor-induced Folliculitis.
A Phase II, multicentric, randomized, double-blind, placebo-controlled, parallel- group trial to confirm the good safaty profile and to explore the preventive effect of topically applied TAR-0520 gel on folliculitis developed in metastatic colorectal cancer (mCRC) patients treated with monoclonal anti-EGFR antibodies.
Read the detailed description
Cetuximab and panitumumab hae become the standard treatment for patients with metastatic colorectal cancer without RAS gene mutation. Hoever, these EGFR inhbitors induce a broad spectrum of cutaneous toxicities (skin side effects) in 75-90% of patients, including the folliculitis involving the face,upper torso and scalp. The folliculitis appears within 1-2 weeks of anti-EGFR therapy and peaks around 3-5 weeks of treatment. There is no approved treatment to prevent or treat EGFR-induced folliculitis. Tarian Pharma has developed a new topical treatment of EGFRi-induced folliculitis.This study aims to confirm the good safety of TAR-0520 gel in colorectal cancer patients treated with cetuximab or panitmumab and eplore , in the same patients , the effect of TAR-0520 gel on the extent and severity of EGFRi-induced folliculitis.
Patients aged 18 years and over with metastatic colorectal carcinoma planned to be treated with cetuximab or panitumumab injections will be included in the study.
Participants will be randomly allocated to receive either the topical active TAR-0520 gel or its vehicle.The study will include a 7days treatment period with once daily applications of the test product followed by a treatment free period until the start of the next chemotherapy cycle usually 7 days later.The study will cover 4 complete chemotherapy cycles, thus lasting at least 56 days.
- Conditions
- EGFR Inhibitor-associated Rash
- Being tested
- Brimonidine tartrate Gel, Placebo gel (no Brimonidine tartrate)
- Keywords
- EGFR inhibitor-induced skin rash;, EGFR inhibitor-induced folliculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brimonidine tartrate GelDrug
Once daily applications for 7 days
Placebo gel (no Brimonidine tartrate)Drug
Once daily applications for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Active arm | Experimental | Brimonidine tartrate gel Receives: Drug: Brimonidine tartrate Gel |
| Placebo arm | Placebo comparator | Not described Receives: Drug: Placebo gel (no Brimonidine tartrate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Treatment - emergent Advers Events (TEAEs)
TEAEs will be tabulated in frequency tables by System Organ Class and Preferred Term, based on the Medical Dictionary for Regulatory Activities (MedDRA). Additional summary tables will be provided for AEs that are considered serious (SAEs), related to the study drug, adverse events of special interest (AESIs), and AEs leading to discontinuation.
The safety conclusions will be based on the comparative analysis of the AEs reported in the two treatment arms.
Measured: At Baseline and then at Day 14, Day 28, Day 42 and Day 56 .
Secondary outcomes (1)
Efficacy of TAR-0520 gel to prevent EGFR-induced folliculits
The preventive effectivness of TAR-0520 gel will be measured by assessing EGFR-induced folliculitis severity using a modified Common Terminology Criteria for Adverse Events (CTCAE) scale (Grade 0-no folliculitis - Grade 4-severe folliculitis)
Measured: The measurements will be performed at Baseline visit and then at Day 14,Day 28,Day 42 and Day 56.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start20 Jan 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EGFR Inhibitor-associated RashStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tarian Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06818058
- Sponsor's protocol ID
- TARIAN 007
- Other IDs
- 2024-516339-28-00
- Status last verified
- Feb 2025
- First submitted
- 23 Jan 2025
- Last updated
- 10 Feb 2025
- 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 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Multicentric, Randomized, Double-blind, Placebo-controlled Study of TAR-0520 Gel in EGFR Inhibitor-induced Folliculitis.
- ClinicalTrials.gov ID
- NCT06818058
- Acronym / sponsor ID
- TARIAN 007
- Conditions
- EGFR Inhibitor-associated Rash
- Keywords
- EGFR inhibitor-induced skin rash;, EGFR inhibitor-induced folliculitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tarian PharmaIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 10 Feb 2025 (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.
A Phase II, multicentric, randomized, double-blind, placebo-controlled, parallel- group trial to confirm the good safaty profile and to explore the preventive effect of topically applied TAR-0520 gel on folliculitis developed in metastatic colorectal cancer (mCRC) patients treated with monoclonal anti-EGFR antibodies.
Detailed description
Cetuximab and panitumumab hae become the standard treatment for patients with metastatic colorectal cancer without RAS gene mutation. Hoever, these EGFR inhbitors induce a broad spectrum of cutaneous toxicities (skin side effects) in 75-90% of patients, including the folliculitis involving the face,upper torso and scalp. The folliculitis appears within 1-2 weeks of anti-EGFR therapy and peaks around 3-5 weeks of treatment. There is no approved treatment to prevent or treat EGFR-induced folliculitis. Tarian Pharma has developed a new topical treatment of EGFRi-induced folliculitis.This study aims to confirm the good safety of TAR-0520 gel in colorectal cancer patients treated with cetuximab or panitmumab and eplore , in the same patients , the effect of TAR-0520 gel on the extent and severity of EGFRi-induced folliculitis.
Patients aged 18 years and over with metastatic colorectal carcinoma planned to be treated with cetuximab or panitumumab injections will be included in the study.
Participants will be randomly allocated to receive either the topical active TAR-0520 gel or its vehicle.The study will include a 7days treatment period with once daily applications of the test product followed by a treatment free period until the start of the next chemotherapy cycle usually 7 days later.The study will cover 4 complete chemotherapy cycles, thus lasting at least 56 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active arm | Experimental | Drug: Brimonidine tartrate GelBrimonidine tartrate gel |
| Placebo arm | Placebo comparator | Drug: Placebo gel (no Brimonidine tartrate) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- male or female, who is at least 18 years of age or older at the screening visit
- patients with clinical diagnosis of metastatic colorectal carcinoma planned to be treated with cetuximab or panitumumab injections as part of the chemotherapy protocol
- patients who can understand and sign the Informed Consent Form, can communicate with investigator,can understand and comply with requierements of the protocol, and can apply the study gel by himself/herself or have giver who can apply the product
- patients with predicted life expectency of > 3 months
- patients willing and able to comply with all of the time commitements and procedural requirements of the clinical trial protocol
Key exclusion criteria (9 listed)
- patients with medical history of EGFR treatment in the past 2 years
- patients with any underlying physical ,psychological or medical condition that, in the opinion of the invstigator, would make it unlikely that the patient will comply with the protocol or complete the study protocol
- patients with any uncotrolled or serious disease, or any medical or surgical condition,that may put the subject at significant risk (according to the investigator's judgement) if he/she participates in the clinical trial
- patients with history of other skin disorders (eg.atopic dermatitis,psoriasis,recurrent skin infections), or a history of illness that, in the opinion of the investigator, would confound the results of the study
- patients with significant skin disease other than EGFRi-induced folliculits within the same body areas planned for study drug application
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 |
|---|---|---|
| Brimonidine tartrate GelOnce daily applications for 7 days | Drug | Active arm |
| Placebo gel (no Brimonidine tartrate)Once daily applications for 7 days | Drug | Placebo arm |
Primary outcome
Frequency of Treatment - emergent Advers Events (TEAEs)
Time frame: At Baseline and then at Day 14, Day 28, Day 42 and Day 56 .
TEAEs will be tabulated in frequency tables by System Organ Class and Preferred Term, based on the Medical Dictionary for Regulatory Activities (MedDRA). Additional summary tables will be provided for AEs that are considered serious (SAEs), related to the study drug, adverse events of special interest (AESIs), and AEs leading to discontinuation. The safety conclusions will be based on the comparative analysis of the AEs reported in the two treatment arms.
1 secondary outcome
Efficacy of TAR-0520 gel to prevent EGFR-induced folliculits
Time frame: The measurements will be performed at Baseline visit and then at Day 14,Day 28,Day 42 and Day 56.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- 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.
Alexandra Lamquin, PhD contact
3 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 Brimonidine tartrate Gel in people with EGFR Inhibitor-associated Rash, run by Tarian Pharma at 3 sites in France.
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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Janusz Czernielewski, MD (+33680338274, janusz.czernielewski@tarianpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Treatment - emergent Advers Events (TEAEs) (time frame: At Baseline and then at Day 14, Day 28, Day 42 and Day 56 .). 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 10 Feb 2025.