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RecruitingNCT06807021Updated Sep 30, 2026

Post-Operative Use of FS2 to Mitigate Scarring in Burn Patients

A Phase 2/3 interventional study of IP1 control cream (Vehicle base) and IP2 - 0.5% w/w FS2 in Burn Scar and Burn Wound, sponsored by Birch BioMed Inc. Recruiting at 2 sites in Canada. Open to participants aged 12 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Birch BioMed Inc · Phase 2/3, Interventional, and Basic science

Updated Sep 30, 2026Start date movedPrimary completion moved+1 moreGo to Updates ↓
Phase
Phase 2/3
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
12 Years to 65 Years
Sex
All
01

Study summary

The goal of this study is to see how an ingredient called kynurenic acid (which we named "FS2") affects scar formation in people with burn injuries that need skin graft surgery. A cream with FS2 will be used on both the area where the skin graft was placed and the area where the skin was taken (donor site). The cream will be applied after the skin has healed. This study will help us understand if FS2 is safe and effective for mitigating skin scar formation in burn patients.

Read the detailed description

For the first 90 days of the study, neither the patient nor the investigator will know which cream is being used: either the control cream (IP1) or the treatment cream (IP2), which contains 0.5% FS2. The assigned study product will be applied to the donor site and the skin graft site. After the first 90 days, all patients will use the FS2 cream for another 90 days in an open-label period where everyone knows they are receiving FS2.

The graft and donor sites will be photographed and assessed (POSAS and VSS), scored and recorded at the initial visit and again at every assessment visit thereafter.

An interim analysis will take place when about half of the participants (36 people) have finished their Day 90 visit. Based on the results, the study may continue as planned with the two-treatment, blinded design, or it may switch to an open-label format where all patients (those already in the study or newly enrolled) will use the FS2 cream.

Oversight - Human Subjects Protection Review section continued:

Site #02 (Edmonton) Approval Number: Pro00151882 Board Name: HREB - Biomedical Panel Board Affiliation: HREB - University of Alberta Board Contact Information: 780-492-8320 (Phone), vnadeau@ualberta.ca (Email)

02

Conditions studied

  • Burn Scar
  • Burn Wound

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Keywords

  • Scar
  • Burn
  • skin graft
  • Kynurenic acid
  • FS2
  • Skin grafted wound
  • Donor Wound
03

In context

Burns

905 studies on the registry are indexed under Burns; 164 are open to participants now.

This study's planned enrollment of 70 is above the median of 40 across 663 interventional studies indexed under Burns.

Browse Burns studies →

Lead sponsor

This is the only study on the registry with Birch BioMed Inc as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Medically able and willing to consent/assent to study requirements
  2. Male and female burn patients
  3. 12 to 65 years of age (inclusive)
  4. Able to understand the study requirements and consent without a translator. Where applicable, participant's legally authorized representative (LAR) is willing and able to agree to the requirements and restrictions of the study, be willing to give voluntary (or assent, if capable), be able to understand and read the questionnaires, carry out all study-related procedures, and communicate effectively with the study staff.
  5. Have a between 15 and 35 kg/m2 (inclusive)
  6. Have clinically acceptable results in the safety laboratory tests as deemed by the investigator
  7. Have full thickness burn injury that required partial thickness skin graft (meshed or sheet) for any location other than the face and genitalia
  8. Skin graft size is between 50 cm2 and 800 cm2 (post-meshing, if a meshed graft)
  9. If skin graft is meshed, maximum skin graft expansion ratio is 1:1.5
  10. Able to apply the IPs as instructed, whether by the participants themselves or their accompanying caregivers

Exclusion criteria

Exclusion Criteria:

  1. Medically unable to consent to study requirements
  2. Treatment site(s) (skin graft site) located on the face and genitalia
  3. Treatment site(s) (skin graft site and skin donor site) that has not reached complete re-epithelization at baseline, based on the investigator's assessment
  4. Expected to be medically unstable for the duration of the study period and an additional 1-month thereafter
  5. Pregnant, or attempting to become pregnant
  6. Subjects who had taken part in an interventional clinical trial within 3 months prior to admission to this trial or who are currently participating in a clinical trial, whether an drug was used or not
  7. Subjects who had any clinical evidence of severe ongoing or prolonged depression or mental illness within the last year
  8. Subjects who smoke more than 20 cigarettes a day
  9. Subjects who have a history of heavy drinking in the past month, defined as more than 14 drinks per week for men or more than 7 drinks per week for women
  10. Subjects who have a history of substance abuse within the 12 months prior to screening (including having been hospitalized for such in an in-patient or out-patient intervention)
  11. Subjects with severe inhalation injury requiring FiO2 >50%, renal failure requiring dialysis or hemodynamic instability requiring vasopressor therapy at the time of initiation of study treatment
  12. Subjects who have scarring from previous interventions or evidence of thermal, electrical or radiation burn scars, tattoos, birthmarks or moles within 5 cm of the treatment sites
  13. Subjects with a history of abnormal keloid scarring
  14. Subjects with additional concurrent illnesses or conditions that may have interfered with wound healing like neoplastic, immune-mediated, or primary infectious disease (e.g. carcinoma, vasculitis, connective tissue disease, immune system disorders, uncontrolled infection, rheumatoid arthritis, chronic renal impairment, significant hepatic impairment, inadequately or uncontrolled congestive heart failure or diabetes mellitus) or any medical condition or history of any condition which may impair wound healing
  15. Subjects with a skin disorder that is chronic or currently active and which the investigator considers will adversely affect the healing of acute wounds or will involve the areas to be examined in this trial (including psoriasis, dermatitis, eczema)
  16. A history of radiotherapy to the study scar area
  17. Subjects who have known sensitivity to any components of the IPs
  18. Any other diagnosis, condition, physical or geographical limitation with the participant
Terms in these criteria, in plain language(5)

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.

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.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

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.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    Skin Grafted wound

    The wound site (injury)

    Drug: IP1 control cream (Vehicle base) · Drug: IP2 - 0.5% w/w FS2

  • Experimental
    Donor Skin Graft Harvest wound

    A Surgical wound

    Drug: IP1 control cream (Vehicle base) · Drug: IP2 - 0.5% w/w FS2

Interventions

  • DrugIP1 control cream (Vehicle base)

    Without FS2

  • DrugIP2 - 0.5% w/w FS2

    FS2 in pharmaceutical compounding base

06

What researchers measure

Primary outcomes

  1. Scar condition of the skin grafted wound on Day 90 as assessed by VSS

    To evaluate the effect of 90-day FS2 cream use, compared to control, on clinician-assessed scar condition assessed by Vancouver Scar Scale (VSS) at the skin grafted wound (Study Arm 1)

    Time frame: 90 days

Secondary outcomes

  1. Scar condition of the donor skin graft harvest site on Day 90 as assessed by VSS

    To evaluate the effect of 90-day FS2 cream use, compared to control, on clinician-assessed scar condition assessed by VSS at the donor skin graft harvest site (Study Arm 2)

    Time frame: 90 days

  2. Scar condition of the skin graft wound on Day 28 and Day 60 as assessed by VSS

    To evaluate the effect of 28- and 60-day FS2 cream use, compared to control, on clinician-assessed scar condition assessed by VSS at: skin grafted wound (Study Arm 1)

    Time frame: Day 28 and Day 60

  3. Scar condition of the donor skin graft harvest site on Day 28 and Day 60 as assessed by VSS

    To evaluate the effect of 28- and 60-day FS2 cream use, compared to control, on clinician-assessed scar condition assessed by VSS at: donor skin graft harvest site (Study Arm 2)

    Time frame: Day 28 and Day 60

  4. Scar condition of the skin grafted wound on Day 28, Day 60, and Day 90 as assessed by the Observer component of POSAS

    To evaluate the effect of 28-, 60- and 90-day FS2 cream use, compared to control, on clinician-assessed scar condition assessed by the Observer component of Patient and Observer Scar Assessment Scale (POSAS) at skin grafted wound (Study Arm 1)

    Time frame: Day 28, Day 60 and Day 90

  5. Scar condition of the donor skin graft harvest site on Day 28, Day 60, and Day 90 as assessed by the Observer component of POSAS

    To evaluate the effect of 28-, 60- and 90-day FS2 cream use, compared to control, on clinician-assessed scar condition assessed by (POSAS) at: donor skin graft harvest site (Study Arm 2)

    Time frame: Day 28, Day 60 and Day 90

  6. Scar condition of the skin grafted wound on Day 28, Day 60, and Day 90 as assessed by the Patient component of POSAS

    To evaluate the effect of 28-, 60- and 90-day FS2 cream use, compared to control, on patient-reported scar condition at: skin grafted wound (Study Arm 1)

    Time frame: Day 28, Day 60 and Day 90

  7. Scar condition of the donor skin graft harvest site on Day 28, Day 60, and Day 90 as assessed by the Patient component of POSAS

    To evaluate the effect of 28-, 60- and 90-day FS2 cream use, compared to control, on patient-reported scar condition at: donor skin graft harvest site (Study Arm 2)

    Time frame: Day 28, Day 60 and Day 90

  8. Scar condition of the skin grafted wound on Day 120 and Day 180 as assessed by the Observer component of POSAS

    To evaluate the effect of 30- and 90-day FS2 cream use, starting 90 days after skin grafted wound's complete re-epithelization, on clinician-assessed scar condition at: skin grafted wound (Study Arm 1) - POSAS

    Time frame: Day 120 and Day 180

  9. Scar condition of the donor skin graft harvest site on Day 120 and Day 180 as assessed by the Observer component of POSAS

    To evaluate the effect of 30- and 90-day FS2 cream use, starting 90 days after skin grafted wound's complete re-epithelization, on clinician-assessed scar condition at: donor skin graft harvest site (Study Arm 2) - POSAS

    Time frame: Day 120 and Day 180

  10. Scar condition of the skin grafted wound on Day 120 and Day 180 as assessed by VSS

    To evaluate the effect of 30- and 90-day FS2 cream use, starting 90 days after skin grafted wound's complete re-epithelization, on clinician-assessed scar condition at: skin grafted wound (Study Arm 1) - VSS

    Time frame: Day 120 and Day 180

  11. Scar condition of the donor skin graft harvest site on Day 120 and Day 180 as assessed by VSS

    To evaluate the effect of 30- and 90-day FS2 cream use, starting 90 days after skin grafted wound's complete re-epithelization, on clinician-assessed scar condition at: donor skin graft harvest site (Study Arm 2) - VSS

    Time frame: Day 120 and Day 180

  12. Scar condition of the skin grafted wound on Day 120 and Day 180 as assessed by the Patient component of POSAS

    To evaluate the effect of 30- and 90-day FS2 cream use, starting 90 days after skin grafted wound's complete re-epithelization, on patient-reported scar condition at: skin grafted wound (Study Arm 1) -POSAS

    Time frame: Day 120 and Day 180

  13. Scar condition of the donor skin graft harvest site on Day 120 and Day 180 as assessed by the Patient component of POSAS

    To evaluate the effect of 30- and 90-day FS2 cream use, starting 90 days after skin grafted wound's complete re-epithelization, on patient-reported scar condition at: donor skin graft harvest site (Study Arm 2) - POSAS

    Time frame: Day 120 and Day 180

  14. Scar condition of the skin grafted wound on Day 120 and Day 180 as assessed by the Observer component of POSAS

    To evaluate the effect of 120- and 180-day FS2 cream use on clinician-assessed scar condition at: skin grafted wound (Study Arm 1) - POSAS

    Time frame: Day 120 and Day 180

  15. Scar condition of the donor skin graft harvest site on Day 120 and Day 180 as assessed by the Observer component of POSAS

    To evaluate the effect of 120- and 180-day FS2 cream use on clinician-assessed scar condition at: donor skin graft harvest site (Study Arm 2) - POSAS

    Time frame: Day 120 and Day 180

  16. Scar condition of the skin grafted wound on Day 120 and Day 180 as assessed by VSS

    To evaluate the effect of 120- and 180-day FS2 cream use on clinician-assessed scar condition at: skin grafted wound (Study Arm 1) - VSS

    Time frame: Day 120 and Day 180

  17. Scar condition of the donor skin graft harvest site on Day 120 and Day 180 as assessed by VSS

    To evaluate the effect of 120- and 180-day FS2 cream use on clinician-assessed scar condition at: donor skin graft harvest site (Study Arm 2) - VSS

    Time frame: Day 120 and Day 180

  18. Scar condition of the skin grafted wound on Day 120 and Day 180 as assessed by the Patient component of POSAS

    To evaluate the effect of 120- and 180-day FS2 cream use on patient-reported scar condition at: skin grafted wound (Study Arm 1)

    Time frame: Day 120 and Day 180

  19. Scar condition of the donor skin graft harvest site on Day 120 and Day 180 as assessed by the Patient component of POSAS

    To evaluate the effect of 120- and 180-day FS2 cream use on patient-reported scar condition at: donor skin graft harvest site (Study Arm 2)

    Time frame: Day 120 and Day 180

  20. Quality of life on Day 28, Day 60, and Day 90 as assessed by the Burn Specific Health Scale-Brief (BSHS-B)

    To evaluate the effect of 28-, 60- and 90-day FS2 cream use, compared to control, on burn injury-related quality of life

    Time frame: Day 28, Day 60 and Day 90

  21. Quality of life on Day 120 and Day 180 as assessed by BSHS-B

    Quality of life on Day 120 and Day 180 as assessed by BSHS-B To evaluate the effect of 30- and 90-day FS2 cream use, starting 90 days after skin grafted wound's complete re-epithelization, on burn injury-related quality of life in those randomized to control for the first 90 days of study

    Time frame: Day 120 and Day 180

  22. Quality of life on Day 120 and Day 180 as assessed by BSHS-B

    To evaluate the effect of 120- and 180-day FS2 cream use on burn injury-related quality of life in those randomized to FS2 cream for the first 90 days of study Quality of life on Day 120 and Day 180 as assessed by BSHS-B

    Time frame: Day 120 and Day 180

Other outcomes

  1. Scar size(cm2) at the skin grafted wound on Day 28, Day 60 and Day 90 as assessed by photographs

    To evaluate the effect of 28-, 60-, and 90-day FS2 cream use, compared to control, on wound scarring from: skin grafted wound (Study Arm 1)

    Time frame: Day 28, Day 60 and Day 90

  2. Scar height(cm) at the skin grafted wound on Day 28, Day 60 and Day 90 as assessed by photographs

    To evaluate the effect of 28-, 60-, and 90-day FS2 cream use, compared to control, on wound scarring from: skin grafted wound (Study Arm 1)

    Time frame: Day 28, Day 60 and Day 90

  3. Scar size(cm2) at the donor skin graft harvest site on Day 28, Day 60 and Day 90 as assessed by photographs

    To evaluate the effect of 28-, 60-, and 90-day FS2 cream use, compared to control, on wound scarring from: donor skin graft harvest site (Study Arm 2)

    Time frame: Day 28, Day 60 and Day 90

  4. Scar height(cm) at the donor skin graft harvest site on Day 28, Day 60 and Day 90 as assessed by photographs

    To evaluate the effect of 28-, 60-, and 90-day FS2 cream use, compared to control, on wound scarring from: donor skin graft harvest site (Study Arm 2)

    Time frame: Day 28, Day 60 and Day 90

  5. Scar size(cm2) at the skin grafted wound on Day 120 and Day 180 as assessed by photographs

    To evaluate the effect of 120- and 180-day FS2 cream use on wound scarring from: skin grafted wound (Study Arm 1)

    Time frame: Day 120 and Day 180

  6. Scar height(cm) at the skin grafted wound on Day 120 and Day 180 as assessed by photographs

    To evaluate the effect of 30- and 90-day FS2 cream use, starting 90 days after skin grafted wound's complete re-epithelization, on wound scarring from: skin grafted wound (Study Arm 1)

    Time frame: Day 120 and Day 180

  7. Scar size(cm2)at the donor skin graft harvest site on Day 120 and Day 180 as assessed by photographs

    To evaluate the effect of 120- and 180-day FS2 cream use on wound scarring from: donor skin graft harvest site (Study Arm 2)

    Time frame: Day 120 and Day 180

  8. Scar height(cm) at the donor skin graft harvest site on Day 120 and Day 180 as assessed by photographs

    To evaluate the effect of 30- and 90-day FS2 cream use, starting 90 days after skin grafted wound's complete re-epithelization, on wound scarring from: donor skin graft harvest site (Study Arm 2)

    Time frame: Day 120 and Day 180

  9. To evaluate the Safety of FS2 Cream - Adverse events

    Report of Adverse Events

    Time frame: Day 0, Day 28, Day 60, Day 90 and Day 180

  10. To evaluate the safety of FS2 cream - Whole Blood Hemoglobin (g/dl)

    Safety Laboratory Parameters - Hematology Parameters (Complete blood count)

    Time frame: Day 0, Day 28, Day 60, Day 90 and Day 180

  11. To evaluate the safety of FS2 cream - Hematocrit (%)

    Safety Laboratory Parameters - Hematology Parameters (Complete blood count)

    Time frame: Day 0, Day 28, Day 60, Day 90 and Day 180

  12. To evaluate the safety of FS2 cream - Red Blood Cell Count

    Safety Laboratory Parameters - Hematology Parameters (Complete blood count)

    Time frame: Day 0, Day 28, Day 60, Day 90 and Day 180

  13. To evaluate the safety of FS2 cream - Red Cell distribution Width

    Safety Laboratory Parameters - Hematology Parameters (Complete blood count)

    Time frame: Day 0, Day 28, Day 60, Day 90 and Day 180

  14. To evaluate the safety of FS2 cream - Mean corpuscular Volume

    Safety Laboratory Parameters - Hematology Parameters (Complete blood count)

    Time frame: Day 0, Day 28, Day 60, Day 90 and Day 180

  15. To evaluate the safety of FS2 cream - Mean corpuscular Hemoglobin

    Safety Laboratory Parameters - Hematology Parameters (Complete blood count)

    Time frame: Day 0, Day 28, Day 60, Day 90 and Day 180

  16. To evaluate the safety of FS2 cream - Mean corpuscular Hemoglobin Concentration

    Safety Laboratory Parameters - Hematology Parameters (Complete blood count)

    Time frame: Day 0, Day 28, Day 60, Day 90 and Day 180

  17. To evaluate the safety of FS2 cream - White Blood Cell Count and Differential

    Safety Laboratory Parameters - Hematology Parameters (Complete blood count)

    Time frame: Day 0, Day 28, Day 60, Day 90 and Day 180

  18. To evaluate the safety of FS2 cream - Platelet Count

    Safety Laboratory Parameters - Hematology Parameters (Complete blood count)

    Time frame: Day 0, Day 28, Day 60, Day 90 and Day 180

  19. To evaluate the safety of FS2 cream - Mean Platelet Volume

    Safety Laboratory Parameters - Hematology Parameters (Complete blood count)

    Time frame: Day 0, Day 28, Day 60, Day 90 and Day 180

  20. To evaluate the safety of FS2 cream - AST

    Safety Laboratory parameters: Clinical Chemical Parameters

    Time frame: Day 0, Day 28, Day 60, Day 90 and Day 180

  21. To evaluate the safety of FS2 cream - ALT

    Safety laboratory parameters: Clinical chemistry parameters:

    Time frame: Day 0, Day 28, Day 60, Day 90 and Day 180

  22. To evaluate the safety of FS2 cream - GGT

    To evaluate the safety of FS2 cream Safety laboratory parameters: Clinical chemistry parameters.

    Time frame: Day 0, Day 28, Day 60, Day 90 and Day 180

  23. To evaluate the safety of FS2 cream - Alkaline Phosphate

    Safety laboratory parameters: Clinical chemistry parameters

    Time frame: Day 0, Day 28, Day 60, Day 90 and Day 180

  24. To evaluate the safety of FS2 cream - Creatinine

    Safety laboratory parameters Clinical chemistry parameters.

    Time frame: Day 0, Day 28, Day 60, Day 90 and Day 180

  25. To evaluate the safety of FS2 cream - BUN

    To evaluate the safety of FS2 cream Safety laboratory parameters: Clinical chemistry parameters.

    Time frame: Day 0, Day 28, Day 60, Day 90 and Day 180

  26. To evaluate the safety of FS2 cream - Bilirubin Total

    Safety laboratory parameters: Clinical chemistry parameters.

    Time frame: Day 0, Day 28, Day 60, Day 90 and Day 180

  27. To evaluate the safety of FS2 cream - Bilirubin Direct

    Safety laboratory parameters: Clinical chemistry parameter.

    Time frame: Day 0, Day 28, Day 60, Day 90 and Day 180

07

Study locations

2 of 2 sites recruiting
  • University of Alberta, Division of Plastic Surgery
    Edmonton, Alberta T6G 2B7, Canada
    Recruiting
  • Centre for Burn Research - Hamilton Health Sciences
    Hamilton, Ontario L8L 2X2, Canada
    Recruiting
    • Esohe Ogbomo, BSc, MPH · ContactEsohe.Ogbomo@TAARI.CA · 905-521-2100
    • Hannah Hamm · ContactHannah.Hamm@TAARI.CA · 905-521-2100
    • Marc Jeschke, PHD · Principal investigator
    • Stephanie Chadwick, MD · Sub investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Start is estimated for Mar 2027; primary completion for Sep 2027, 6 months later.

Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 30, 2026: start May 2026 → Mar 2027, primary completion Oct 2026 → Sep 2027 and completion Nov 2026 → Sep 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jan 22, 2025
First posted
Feb 4, 2025
StartEst.
Mar 2027was May 2026
Primary completionEst.
Sep 2027was Oct 2026
CompletionEst.
Sep 2027was Nov 2026
Last update
Sep 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
May 15, 2026→Mar 2027
Sep 30, 2026
Primary completion
Oct 15, 2026→Sep 2027
Sep 30, 2026
Study completion
Nov 6, 2026→Sep 2027
Sep 30, 2026
Show all 1 update
  1. Sep 30, 2026
    Start date May 15, 2026→Mar 2027
    Primary completion Oct 15, 2026→Sep 2027
    Study completion Nov 6, 2026→Sep 2027
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06807021
Lead sponsor
Birch BioMed Inc
Collaborators
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Responsible party
Sponsor
First posted
Feb 4, 2025
Start date
Mar 2027 (estimated)
Primary completion
Sep 2027 (estimated)
Completion
Sep 2027 (estimated)
Last update
Sep 30, 2026

Study contacts

Adam Kuttenkeuler
Contact
akuttenkeuler@nutrasource.ca
+1519-341-3367 ext. 113
Stephanie Recker
Contact
srecker@nutrasource.ca
1-887-557-7722
Carlos Camozzi, MD, PHD
study director · BirchBioMed Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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