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| Name | Class |
|---|---|
| NanoSHIFT LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pilot Arm | Experimental | Self-controlled 12 healthy subjects receiving an ablative fractional CO2 laser procedure followed by topical application of NanoDOX® Hydrogel |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Wound healing | Biopsied areas will not be sutured, so wound healing will be evaluated by clinical assessment; the investigators will assess the wounds on the untreated and treated areas with NanoDOX® Hydrogel after ablative fractional laser. | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dieter Manstein, MD, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MGH Clinical Unit for Research Trials And Outcome | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23460557 | Background | 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. | |
| 30266385 | 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. |
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There is no plan to make individual participant data (IPD) available to other researchers.
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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Self-controlled single-site study of healthy subjects receiving an ablative fractional CO2 laser procedure followed by topical application of NanoDOX® Hydrogel
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| CO2 Ablative Fractional Laser | Device | CO2 Ablative Fractional Laser will be applied to healthy skin areas |
|
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| 22907286 | 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. |
| 28687935 | 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. |
| 31628774 | 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. |
| 30585822 | 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. |