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Investigation of Laser Assisted Drug Delivery of NanoDOX®

Primary Purpose

Wounds and Injury

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

NanoDOX® Hydrogel

CO2 Ablative Fractionla Laser

About this trial

This is an interventional treatment trial for Wounds and Injury focused on measuring WOUND, DRUG-DELIVERY

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 hypertrophic scars or keloids; History of extreme photosensitivity;
History of hyperpigmentation.

Sites / Locations

MGH Clinical Unit for Research Trials And OutcomeRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pilot Arm

Arm Description

Self-controlled 10 healthy subjects receiving an ablative fractional CO2 laser procedure followed by topical application of NanoDOX® Hydrogel

Outcomes

Primary Outcome Measures

Skin drug uptake

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

Wound healing

Biopsied areas will not be sutured, so wound healing will be evaluated by clinical assessment; the investigators will use a ruler to measure the size of the wounds on the untreated and treated areas with NanoDOX® Hydrogel after ablative fractional laser.

Full Information

NCT ID

NCT05411484

First Posted

June 1, 2022

Last Updated

October 4, 2023

Sponsor

Massachusetts General Hospital

Collaborators

NanoSHIFT LLC

1. Study Identification

Unique Protocol Identification Number

NCT05411484

Brief Title

Investigation of Laser Assisted Drug Delivery of NanoDOX®

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 23, 2023 (Anticipated)

Primary Completion Date

April 23, 2024 (Anticipated)

Study Completion Date

May 23, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

Collaborators

NanoSHIFT LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

Brief 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.

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, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Wounds and Injury

Keywords

WOUND, DRUG-DELIVERY

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

Self-controlled single-site study of 10 healthy subjects receiving an ablative fractional CO2 laser procedure followed by topical application of NanoDOX® Hydrogel

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pilot Arm

Arm Type

Experimental

Arm Description

Self-controlled 10 healthy subjects receiving an ablative fractional CO2 laser procedure followed by topical application of NanoDOX® Hydrogel

Intervention Type

Drug

Intervention Name(s)

NanoDOX® Hydrogel

Other Intervention Name(s)

Doxycycline application

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

CO2 Ablative Fractionla Laser

Other Intervention Name(s)

laser treatment

Intervention Description

CO2 Ablative Fractional Laser will be applied to healthy skin areas

Primary Outcome Measure Information:

Title

Skin drug uptake

Description

Time Frame

3 days

Secondary Outcome Measure Information:

Title

Wound healing

Description

Time Frame

3 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 hypertrophic scars or keloids; History of extreme photosensitivity; History of hyperpigmentation.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lais Gomes

Phone

(617) 726-4454

lgomes@mgh.harvard.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Neera Nathan, MD, MSHS

nnathan2@mgh.harvard.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dieter Manstein, MD, PhD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

MGH Clinical Unit for Research Trials And Outcome

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michelle Sickles

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

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

Citations:

PubMed Identifier

23460557

Citation

Waibel JS, Wulkan AJ, Shumaker PR. Treatment of hypertrophic scars using laser and laser assisted corticosteroid delivery. Lasers Surg Med. 2013 Mar;45(3):135-40. doi: 10.1002/lsm.22120. Epub 2013 Mar 4.

Results Reference

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PubMed Identifier

30266385

Citation

Alegre-Sanchez A, Jimenez-Gomez N, Boixeda P. Laser-Assisted Drug Delivery. Actas Dermosifiliogr (Engl Ed). 2018 Dec;109(10):858-867. doi: 10.1016/j.ad.2018.07.008. Epub 2018 Sep 25. English, Spanish.

Results Reference

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PubMed Identifier

22907286

Citation

Qu L, Liu A, Zhou L, He C, Grossman PH, Moy RL, Mi QS, Ozog D. Clinical and molecular effects on mature burn scars after treatment with a fractional CO(2) laser. Lasers Surg Med. 2012 Sep;44(7):517-24. doi: 10.1002/lsm.22055. Epub 2012 Jul 31.

Results Reference

background

PubMed Identifier

28687935

Citation

Waibel JS, Rudnick A, Shagalov DR, Nicolazzo DM. Update of Ablative Fractionated Lasers to Enhance Cutaneous Topical Drug Delivery. Adv Ther. 2017 Aug;34(8):1840-1849. doi: 10.1007/s12325-017-0516-9. Epub 2017 Jul 7.

Results Reference

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PubMed Identifier

31628774

Citation

Benzaquen M, Collet-Villette AM, Delaporte E. Combined treatment of hypertrophic and keloid scars with intralesional injection of corticosteroids and laser-assisted corticosteroid delivery. Dermatol Ther. 2019 Nov;32(6):e13126. doi: 10.1111/dth.13126. Epub 2019 Nov 6. No abstract available.

Results Reference

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PubMed Identifier

30585822

Citation

Moore AL, desJardins-Park HE, Duoto BA, Mascharak S, Murphy MP, Irizarry DM, Foster DS, Jones RE, Barnes LA, Marshall CD, Ransom RC, Wernig G, Longaker MT. Doxycycline Reduces Scar Thickness and Improves Collagen Architecture. Ann Surg. 2020 Jul;272(1):183-193. doi: 10.1097/SLA.0000000000003172.

Results Reference

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Investigation of Laser Assisted Drug Delivery of NanoDOX®

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