Investigation of Laser Assisted Drug Delivery of NanoDOX®

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Wounds and Injury

Intervention / Treatment
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* Drug: NanoDOX® Hydrogel
* Device: CO2 Ablative Fractionla Laser


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pilot Arm<br>Self-controlled 10 healthy subjects receiving an ablative fractional CO2 laser procedure followed by topical application of NanoDOX® Hydrogel | Drug: NanoDOX® Hydrogel<br>* 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<br>* Other names: Doxycycline application;Device: CO2 Ablative Fractionla Laser<br>* CO2 Ablative Fractional Laser will be applied to healthy skin areas<br>* Other names: laser treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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WOUND, DRUG-DELIVERY