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RECELL for Healing After CO2 Laser Treatment in Facelift Patients
NCT05386368Phase 4
Key facts
- Status
- Terminated
- Start
- Mar 2023
- Primary completion
- Jul 2023
- Countries
- 1
- Sponsor
- Wake Forest University Health Sciences
- Modality
- Cell Therapies, Device-based Delivery
- Drugs
- ReNovaCell
- Conditions
- photoaging
01
Overview
Phase 4, randomised, double-blind trial of ReNovaCell in photoaging (2 arms), sponsored by Wake Forest University Health Sciences. Primary endpoints: Change in Skin Sensitivity - Redness at 3 months, Change in Skin Sensitivity - Sensitivity to Light at 3 months and 4 more. Started Mar 2023; status: terminated.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Right receives ReCell (A)
Right perioral area receives ReCell; Left receives saline spray.
Left receives ReCell (B)
Left perioral area receives ReCell; Right receives saline spray.
03
Who it enrols
Adults 18 years or older undergoing facelift with perioral CO2 laser treatment, with Fitzpatrick skin type 1 or 2, and no prior perioral CO2 laser resurfacing.
04
Endpoints
Primary
Change in Skin Sensitivity - Redness
Change in Skin Sensitivity - Sensitivity to Light
Change in Skin Sensitivity - Tightness
Change in Skin Sensitivity - Itching
Change in Skin Sensitivity - Burning
Secondary
Healing Within 2 Weeks Post-op
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