Investigation of Laser Assisted Drug Delivery of NanoDOX®

Phase 2

Active, not recruiting

• Conditions: Wounds and Injury
• Interventions: Drug: NanoDOX® Hydrogel; Device: CO2 Ablative Fractional Laser

• Registration Number: NCT05411484
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

This is a self-controlled single-site study of healthy subjects receiving an ablative fractional CO2 (carbon dioxide) 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 2 visits of 4 hours in total over approximately 1 week. An optional third visit will take place approximately 6 weeks after Visit 1. In this study, 20 subjects are expected to enroll with a goal of 12 healthy subjects to enroll and complete the study.

Detailed 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, 2 study visits when they will receive CO2 ablative fractional laser treatment, NanoDOX® Hydrogel application, and skin biopsies, and 1 optional study visit for wound healing assessment. Laser procedure will happen only during visit 1, visit 2 will happen 2 days after visit 1, and visit 3 will happen approximately 6 weeks after visit 1. In total, 7 skin biopsies will be performed.

Study Timeline

• Study First Submitted: 2022-06-01
• Study First Submitted QC: 2022-06-06
• Study First Posted: 2022-06-09
• Study Start: 2023-11-29
• Primary Completion: 2024-10-02
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2024-12-20
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Subject must be able and willing to provide written informed consent and comply with the requirements of the study protocol;
• Subject must be able to read and understand English;
• Any gender and any Fitzpatrick skin type;
• Age equal to or greater than 18 years old;
• Willing to sun protect treated area (sunscreen or cover the area with clothes) for the duration of enrollment in the study and 1 year after treatment.
• Subjects must be willing to undergo skin biopsies

Exclusion Criteria

• Participation in another investigational drug or device clinical trial in the past 30 days;
• Are pregnant or lactating;
• History of allergic reaction to topical or local anesthesia;
• History of allergic reaction to Doxycycline or other tetracyclines;
• Regular intake of high doses of anti-inflammatory drugs (aspirin >81 mg/day, ibuprofen, corticosteroids, etc.) , immunosuppressive drugs or biologics;
• Clinically significant abnormal findings or conditions which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study;
• Laser treatment in past six months; History of poor wound healing;
• History of keloids; History of extreme photosensitivity;
• History of severe hyperpigmentation; History of tattoos on thighs.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pilot Arm	CO2 Ablative Fractional Laser	Self-controlled 12 healthy subjects receiving an ablative fractional CO2 laser procedure followed by topical application of NanoDOX® Hydrogel
Pilot Arm	NanoDOX® Hydrogel	Self-controlled 12 healthy subjects receiving an ablative fractional CO2 laser procedure followed by topical application of NanoDOX® Hydrogel

Primary Outcome Measures

Name	Time	Method
Skin drug uptake	3 days	The depth of drug uptake will be measured by histology analysis. To determine if ablative fractional laser therapy combined with NanoDOX® topical drug improves the depth of drug uptake, fluorescence microscopy will be used to measure the concentration of the drug inside the skin by the amount of fluorescence created by the drug will be quantified.

Secondary Outcome Measures

Name	Time	Method
Wound healing	6 weeks	Biopsied areas will not be sutured, so wound healing will be evaluated by clinical assessment; the investigators will assess the wounds on the untreated and treated areas with NanoDOX® Hydrogel after ablative fractional laser.

Trial Locations

Locations (1)

MGH Clinical Unit for Research Trials And Outcome; 🇺🇸 Boston, Massachusetts, United States