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Wounds and InjuryPhase 2NCT05411484

Investigation of Laser Assisted Drug Delivery of NanoDOX®

A Phase 2 study testing NanoDOX® Hydrogel and CO2 Ablative Fractional Laser in people with Wounds and Injury, run by Massachusetts General Hospital at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Wounds and Injury
What is being tested?
NanoDOX® Hydrogel and CO2 Ablative Fractional Laser
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
29 Nov 2023to Mar 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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;
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • MGH Clinical Unit for Research Trials And Outcome

    Boston, Massachusetts, 02114

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
NanoDOX® Hydrogel, CO2 Ablative Fractional Laser
Keywords
WOUND, DRUG-DELIVERY
Medical subject headings
Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NanoDOX® HydrogelDrug

    Also called Doxycycline application

    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

  • CO2 Ablative Fractional LaserDevice

    Also called laser treatment

    CO2 Ablative Fractional Laser will be applied to healthy skin areas

Study groups in NCT05411484
Study groupRoleWhat they receive
Pilot ArmExperimentalSelf-controlled 12 healthy subjects receiving an ablative fractional CO2 laser procedure followed by topical application of NanoDOX® Hydrogel
Receives: Drug: NanoDOX® Hydrogel; Device: CO2 Ablative Fractional Laser

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 days

Secondary outcomes (1)

  1. 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.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2022
  2. Study start29 Nov 2023
  3. Primary completionMar 2027 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Self-controlled single-site study of healthy subjects receiving an ablative fractional CO2 laser procedure followed by topical application of NanoDOX® Hydrogel
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05411484
Sponsor's protocol ID
2022P001117
Status last verified
Jul 2026
First submitted
1 Jun 2022
Last updated
20 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No: There is no plan to make individual participant data (IPD) available to other researchers.

Publications

  • 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.

    PubMed 23460557

  • 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.

    PubMed 30266385

  • 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.

    PubMed 22907286

  • 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.

    PubMed 28687935

  • 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.

    PubMed 31628774

  • 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.

    PubMed 30585822

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NanoDOX® Hydrogel and CO2 Ablative Fractional Laser in people with Wounds and Injury, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Skin drug uptake (time frame: 3 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05411484, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.

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