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	Payal Patel, MD
Phone	617-726-4454
Email	ppatel86@mgh.harvard.edu
Status	Recruiting
Phase	Phase 2
Start date	November 29, 2023
Completion date	May 23, 2024

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