Investigation of Laser Assisted Drug Delivery of NanoDOX®

Status Recruiting

Clinical Trial Summary

This is a self-controlled single-site study of 10 healthy subjects receiving an ablative fractional CO2 laser procedure followed by topical application of NanoDOX® Hydrogel (1% doxycycline). The study includes skin biopsies to evaluate the effects of NanoDOX® Doxycycline Monohydrate Gel on wound healing after the ablative laser procedure. Study subjects will be asked to do two visits of approximately 4 hours over two weeks.

Clinical Trial Description

Effective topical delivery of any pharmaceutical agent requires small molecule drugs to penetrate the epidermis, yet the absorption of topical products through the epidermis is limited. In this study, the investigators are looking for healthy volunteers who are eligible to help us to determine the safety and efficacy of ablative fractional laser therapy combined with NanoDOX. The investigators are doing the research to evaluate drug delivery of topical NanoDOX® Hydrogel following ablative fractional CO2 laser treatment and our secondary objective is to evaluate the efficacy of NanoDOX® for wound healing. Subjects will have a screening visit to determine eligibility, and 2 study visits when they will receive CO2 ablative fractional laser treatment, NanoDOX® Hydrogel application, and skin biopsies. Laser procedure will happen only during visit 1 and visit 2 will happen 2 days after visit 1. In total, 7 skin biopsies will be performed. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05411484
Study type	Interventional
Source	Massachusetts General Hospital
Contact	Alicia Van Cott, MSN
Phone	617-726-4454
Email	avancott@mgb.org
Status	Recruiting
Phase	Phase 2
Start date	November 29, 2023
Completion date	August 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02655354` - A Policy Relevant US Trauma Care System Pragmatic Trial for PTSD and Comorbidity	N/A
Active, not recruiting	`NCT04534959` - Strategy to Avoid Excessive Oxygen for Critically Ill Trauma Patients	Phase 3
Not yet recruiting	`NCT04387305` - Traumatic Injury Clinical Trial Evaluating Tranexamic Acid in Children: An Efficacy Study	Phase 3
Completed	`NCT02884999` - Management of Bleeding and Coagulopathy in Trauma and Compliance to European Trauma Guidelines	N/A
Recruiting	`NCT03400345` - Human Upper Extremity Allotransplantation: F/U Protocol
Recruiting	`NCT04460872` - Locomotor Training With Testosterone to Promote Bone and Muscle Health After Spinal Cord Injury	Phase 2
Completed	`NCT03764930` - Attention to Retinoblastoma Diagnosed in the Trauma Setting
Completed	`NCT04753723` - The Use of a Platform Wound Device for Reducing Infection	Phase 4
Terminated	`NCT02469168` - Epidermal Coverage of Traumatic Wound Injuries Via Use of Autologous Spray Skin Applied Over Bilayered Wound Matrix	N/A
Completed	`NCT03805646` - Mobile Phone-administered Triage Tool to Followup on Discharged Trauma Patients	N/A
Not yet recruiting	`NCT03191279` - First Aid by Laypersons - Effect on Mortality and Length of Stay	N/A
Recruiting	`NCT06374225` - Strategy to Avoid Excessive Oxygen Using an Autonomous Oxygen Titration Intervention	N/A
Completed	`NCT01594385` - Seprafilm in Open Abdomens: a Study of Wound and Adhesion Characteristics in Trauma Damage Control Patients	N/A
Active, not recruiting	`NCT04534972` - Strategy to Avoid Excessive Oxygen in Major Burn Patients	Phase 3