Investigation of Laser Assisted Drug Delivery of NanoDOX®

Wounds and Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05411484
• Other study ID #: 2022P001117
• Status: Recruiting
• Phase: Phase 2
• Start date: November 29, 2023
• Est. completion date: August 2024

Study information

• Verified date: May 2024
• Source: Massachusetts General Hospital
• Contact: Alicia Van Cott, MSN
• Phone: 617-726-4454
• Email: avancott[@]mgb.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Wounds and Injuries
• Wounds and Injury

Intervention

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

Device:
• CO2 Ablative Fractionla Laser
CO2 Ablative Fractional Laser will be applied to healthy skin areas

Locations

Country	Name	City	State
United States	MGH Clinical Unit for Research Trials And Outcome	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	NanoSHIFT LLC

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	3 days