Investigation of Laser Assisted Drug Delivery of NanoDOX®

NCT05411484 | Active Not Recruiting Phase 2 FDA Drug FDA Device

• 1 other identifier: 2022P001117
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Wounds and Injury

Keywords

WOUND; DRUG-DELIVERY

Outcome Measures

Primary Outcomes (1)

• 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.

  3 days

Secondary Outcomes (1)

• Wound healing

  6 weeks

Study Arms (1)

Pilot Arm

EXPERIMENTAL

Self-controlled 12 healthy subjects receiving an ablative fractional CO2 laser procedure followed by topical application of NanoDOX® Hydrogel

Drug: NanoDOX® Hydrogel; Device: CO2 Ablative Fractional Laser

Interventions

NanoDOX® Hydrogel DRUG

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

Also known as: Doxycycline application

Pilot Arm

CO2 Ablative Fractional Laser DEVICE

CO2 Ablative Fractional Laser will be applied to healthy skin areas

Also known as: laser treatment

Pilot Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• NanoSHIFT LLC: collaborator

Study Sites (1)

MGH Clinical Unit for Research Trials And Outcome

Boston, Massachusetts, 02114, United States

Location

Related Publications (6)

• 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.

  PMID: 23460557 BACKGROUND

• 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.

  PMID: 30266385 BACKGROUND

• 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.

  PMID: 22907286 BACKGROUND

• 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.

  PMID: 28687935 BACKGROUND

• 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.

  PMID: 31628774 BACKGROUND

• 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.

  PMID: 30585822 BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Laser Therapy

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Dieter Manstein, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 9, 2022
• Study Start: November 29, 2023
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: October 28, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)