Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Heatwrap 1 · 1 trial · 1 indication
Events associated with Day X wear (eg, Day 5) assessed morning of Day X+1 (eg, Day 6). Significant skin event: at least moderate erythema, elevated response or pain upon touch (associated with non-zero erythema). Erythema grading scale: 0 (no visible erythema) to 3.0 (severe erythema, very intense redness) with 0.5 increments. Moderate erythema (2.0): definite redness. Elevated response: edema, papules, vesicle (≤ 0.5 centimeter \[cm\] diameter), bullae (\> 0.5 cm diameter), miliaria rubra, profunda or follicular response. Pain upon touch: skin grader asked "Does your skin hurt when I touch it?"
| Arm | Type | Description |
|---|---|---|
| Heatwrap 1 | EXPERIMENTAL | Experimental heatwrap device for the lower back |
| Name | Type | Description |
|---|---|---|
| Heatwrap 1 | DEVICE | 8 hours continuous topically-applied heat |
Inclusion Criteria: * The subject is a male or female in generally good health greater or equal to 35 years of age; * Female subjects of child-bearing potential and those who are post-menopausal for less than 2 years must be using a medically-approved method of contraception (i.e., oral, transderma...
Heatwrap 1 is a disposable heatwrap device intended for use on the lower back. It is being studied in healthy adults to evaluate its safety, tolerability, and on-body temperature. The device is currently in Phase 3 clinical development.
Heatwrap 1 is being developed by Pfizer, Inc. (NYSE: PFE). The company is conducting clinical trials to assess the safety and performance of this disposable heatwrap device for lower back use.
Heatwrap 1 is in Phase 3 clinical development. A Phase 3 trial has been completed to evaluate the safety, tolerability, and on-body temperature of the device in healthy adults. It is an investigational product and has not been approved by regulatory authorities.
Heatwrap 1 has one completed clinical trial, registered as NCT01055262. This Phase 3 study evaluated the safety, tolerability, and on-body temperature of the disposable heatwrap device for the lower back in 169 healthy adults aged 35 years and older.
The clinical trial for Heatwrap 1, NCT01055262, was an uncontrolled study. It did not use randomization, blinding, or a control group. The trial enrolled 169 healthy volunteers and has been completed.