Investigation of Laser Assisted Drug Delivery of NanoDOX®

Last updated: December 18, 2024
Sponsor: Massachusetts General Hospital
Overall Status: Active - Not Recruiting

Phase

2

Condition

N/A

Treatment

CO2 Ablative Fractionla Laser

NanoDOX® Hydrogel

CO2 Ablative Fractional Laser

Clinical Study ID

NCT05411484
2022P001117
  • Ages 18-80
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject must be able and willing to provide written informed consent and comply withthe 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) forthe duration of enrollment in the study and 1 year after treatment.

  • Subjects must be willing to undergo skin biopsies

Exclusion

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 opinionof the Investigator, interfere with study evaluations or pose a risk to subjectsafety 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

Total Participants: 10
Treatment Group(s): 3
Primary Treatment: CO2 Ablative Fractionla Laser
Phase: 2
Study Start date:
November 29, 2023
Estimated Completion Date:
February 28, 2025

Study 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.

Connect with a study center

  • MGH Clinical Unit for Research Trials And Outcome

    Boston, Massachusetts 02114
    United States

    Site Not Available

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