Investigation of Laser Assisted Drug Delivery of NanoDOX®

October 24, 2025 updated by: Dieter Manstein, MD, Massachusetts General Hospital

Self-controlled, Single-site Trial Investigation of Laser Assisted Drug Delivery of NanoDOX®

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • MGH Clinical Unit for Research Trials And Outcome

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pilot Arm
Self-controlled 12 healthy subjects receiving an ablative fractional CO2 laser procedure followed by topical application of NanoDOX® Hydrogel
Drug: NanoDOX® Hydrogel
NanoDOX® Hydrogel (Doxycycline Monohydrate USP) will be applied on the areas of the skin previously treated by the Co2 Ablative Fractional Laser and also on a small non treated area of the subject's skin
Other Names:
  • Doxycycline application
Device: CO2 Ablative Fractional Laser
CO2 Ablative Fractional Laser will be applied to healthy skin areas
Other Names:
  • laser treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin drug uptake
Time Frame: 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.
3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound healing
Time Frame: 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.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

NanoSHIFT LLC

Investigators

  • Principal Investigator: Dieter Manstein, MD, PhD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2023

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

June 1, 2022

First Submitted That Met QC Criteria

June 6, 2022

First Posted (Actual)

June 9, 2022

Study Record Updates

Last Update Posted (Estimated)

October 28, 2025

Last Update Submitted That Met QC Criteria

October 24, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022P001117

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Wounds and Injury

Clinical Trials on NanoDOX® Hydrogel

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe