Clinical trial NCT05411484: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Wounds and Injury
Keywords: WOUND
DRUG-DELIVERY
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: NanoSHIFT LLC
First posted: 2022-06-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Self-controlled single-site study of healthy subjects receiving an ablative fractional CO2 laser procedure followed by topical application of NanoDOX® Hydrogel
Primary purpose: TREATMENT

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.

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.

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 keloids; History of extreme photosensitivity;
* History of severe hyperpigmentation; History of tattoos on thighs.

Primary outcomes:
measure: Skin drug uptake
timeFrame: 3 days
Secondary outcomes:
measure: Wound healing
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: MGH Clinical Unit for Research Trials And Outcome
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Dieter Manstein, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
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.
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.
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.