WithdrawnPhase 2

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

Stopped: No longer aligned with company strategy

0Started 2022-08-01

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.
✓. 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

✕. 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)

Time to re-epithelization

Timeframe: From Day 0 to Month 12

NCT IDNCT04684121

SponsorXequel Bio, Inc.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-01

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.
✓. 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

✕. 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)