Study of the Efficacy and Safety of Granexin® Gel to Improve Burn Wound Healing

NCT04684121 | Withdrawn Phase 2 FDA Drug

• 2 other identifiers: 2019-BURN-01CDMRP-MB190074
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the efficacy of Granexin® gel to promote accelerated healing of second-degree (deep partial thickness) thermal burns.

Conditions

Second Degree Burn; Thermal Burn

Outcome Measures

Primary Outcomes (1)

• Time to re-epithelization

  Time (in days) to 100% re-epitheliazation of deep second degree burns as determined through clinical assessments

  From Day 0 to Month 12

Secondary Outcomes (6)

• Reduction in scar severity at Month 12

  Month 12

• Proportion of burns that convert from partial thickness burns to full thickness burns

  From Day 0 to Day 28

• Proportion of subjects needing additional burn interventions

  From Day 0 to Day 28

• Time to skin grafting

  From Day 0 to Month 12

• Incidence of infection

  From Day 0 to Month 12

Other Outcomes (3)

• Reduction in scar severity

  Months 6 and 9

• Histological examination of burns

  Punch biopsies collected from each target burn on Day 0, Day 7 and Month 12

• Exploratory gene expression for markers of wound healing and scar formation

  Collected from each target burn on Day 0, Day 7 and Month 12

Study Arms (2)

Granexin gel

EXPERIMENTAL

Within-subject comparison of Granexin® Gel versus vehicle gel (placebo). Granexin® gel 200 μM will be applied daily over ten days. Granexin® will be applied to one of two selected target burns.

Drug: Granexin® gel (200 μM)

Vehicle Gel

PLACEBO COMPARATOR

Within-subject comparison of Granexin® Gel versus vehicle gel (placebo). Vehicle gel will be applied daily over ten days. Vehicle will be applied to one of two selected target burns.

Drug: Vehicle gel

Interventions

Granexin® gel (200 μM) DRUG

Granexin® gel (200 μM) will be topically applied once daily for 10 days in association with standard of care (SOC) wound cleaning and ACTICOAT Flex 3TM dressing.

Granexin gel

Vehicle gel DRUG

Vehicle gel will be topically applied once daily for 10 days in association with standard of care (SOC) wound cleaning and ACTICOAT Flex 3TM dressing.

Vehicle Gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or older
• Women of childbearing potential (WOCBP) must have a negative pregnancy test at Screening and must agree to use hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence from the time of informed consent through Day 28 of the study; or female subjects must be postmenopausal (defined as 12 months since last menstruation) or surgically sterilized.
• Male subjects must abstain from sex with WOCBP or use an adequate method of contraception (as described above) from the time of informed consent through Day 28 of the study.
• Must have two comparable (similar body location, similar burn area and burn severity), noncontiguous deep second-degree thermal burns (target burns) caused by a fire/flame, scalds, or a hot object.
• Must have two target burns:
• No single target burn less than 1% TBSA
• All burns less than 20% cumulative TBSA
• Any treatment administered prior to randomization must be similar to both target burns and must be removed or discontinued prior to randomization.
• Signed informed consent form

You may not qualify if:

• Chemical, radiation, or electrical burns
• Burns older than 36 hours prior to study randomization
• Target burns more severe than deep second-degree
• Target burns to the hands, face, neck, or feet. Burn area may include hands and feet where target burn will only include areas extending above the wrist or ankle.
• Target burns that are superficial second-degree burn wounds expected to heal within two weeks
• Evidence of active infection, including cellulitis, at the site of the target burns
• Known collagen vascular diseases
• Any history of malignancy within the last 5 years or the presence of any active systemic cancer (exception will be basal cell skin cancer in a non-burned area)
• History of clinically significant cardio/pulmonary conditions
• Clinically significant medical conditions as determined by the clinical Investigator, which would impair wound healing including renal, hepatic, hematologic, neurologic, or immune disease
• Known inability or unavailability to complete required study visits
• Critical illnesses such as those requiring ventilator support, or having a systemic infection or hemodynamic instability, defined as a mean arterial pressure less than 60 mm Hg or requiring vasoactive medications to support blood pressure
• Major acute or chronic medical illnesses that could affect wound healing (e.g. peripheral vascular disease, insulin dependent diabetes, blood clotting disorder)
• Currently receiving treatment with medications that inhibit or compromise wound healing. Examples include immunosuppressive agents, topical growth factors, therapeutic anticoagulants, antiplatelet drugs, and systemic steroids such as warfarin, clopidogrel, or prednisone. The use of anticoagulants does not include deep vein thrombosis (DVT) prophylaxis. Subjects may use aspirin or lovenox.
• Any condition which, in the opinion of the Investigator, places the subject at unacceptable risk if he/she were to participate in the study

Sponsors & Collaborators

• Xequel Bio, Inc.: lead
• United States Department of Defense: collaborator

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: December 24, 2020
• Study Start: August 1, 2022
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share