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Assessing the Efficacy of Repeat, Monthly Treatments of Alexandrite Laser for NF1-associated Cutaneous Neurofibromas (cNFs)

A legfontosabb adatok

Ki végzi
Massachusetts General Hospital
Hol
Boston (Egyesült Államok)A helyszín megnézése
Azonosító
Állapot
Felfüggesztve
Résztvevők
10 fő, tervezett
Kezdés
2027. jan.
Várható befejezés
2027. dec.
A vizsgálat típusa
Beavatkozással járó, 2 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
A vizsgált kezelések
  • GentleMax Pro (with skin cooling)
  • GentleMax Pro (without skin cooling)
A regiszteradat frissítve
2026. június 4.
Miért állt le
Study is currently not funded at this time.

Ki vehet részt

Életkor
18 év felett
Nem
Nők és férfiak
Egészséges önkéntesek
Nem vehetnek részt

A regiszter feltételei, szó szerint

Mind a 19 feltétel megnézéseKevesebb

Ki vehet részt

  • Participant is an adult ≥18 years of age
  • Participant has a diagnosis of NF1 based on germline genetic testing or by meeting ≥ 2 the following criteria:
  • Family history of NF1
  • Six or more light brown ("cafe-au-lait") spots on the skin
  • Presence of two or more neurofibromas of any type, or one or more plexiform neurofibromas
  • Freckling under the arms or in the groin area
  • Two or more pigmented, benign bumps on the eye's iris (Lisch nodules)
  • A distinctive bony lesion: dysplasia (abnormal growth) of the sphenoid bone behind the eye, or dysplasia of long bones, often in the lower leg
  • Tumor on the optic nerve that may interfere with vision
  • Participant is seeking treatment for cNF
  • Participants must have ≥ 12 paired cNF (6 to be treated without DCD, 6 to be treated with DCD) that are visible and measure at least 2 mm in size in the target treatment area. The target treatment area must be amenable to both laser treatments and surveillance with digital and 3D photography. Preferred locations are trunk (back or chest), arms and legs
  • Participant is able and willing to comply with all visit, treatment, and evaluation schedules and requirements
  • Participant is able to understand and provide written informed consent
  • Participant has no concurrent injury or wound in the target area

Ki nem vehet részt

  • Participant has any condition which, in the Investigator's opinion, would make it unsafe (for the participant or study personnel) to treat the participant as part of this research study
  • Participant cannot give informed consent or adhere to study schedule
  • Participant is Fitzpatrick skin type V-VI
  • Participant is actively tanning during the course of the study
  • For female participants: participant is pregnant

Helyszínek itt: Egyesült Államok

  • Wellman Center for Photomedicine, Massachusetts General HospitalBoston, Egyesült Államok

A vizsgálatról

Mit akar kideríteni a vizsgálat

The goal of this clinical trial is to evaluate the tolerability and effectiveness of multiple treatments of Alexandrite (755 nm) Laser in those with Neurofibromatosis Type 1 (NF1) Cutaneous Neurofibromas (cNFs). The main questions it aims to answer are:

A teljes eredeti leírásKevesebb

Will performing up to 6 months of treatment sessions with alexandrite laser will result in tolerable local skin reactions and reduction in both individual cNF size by >50% as well as improved cNF appearance in the treated field? If there is a comparison group: Researchers will compare laser treatment with cooling to both laser treatment without cooling and an untreated control see if laser treatments are effective and if cooling makes treatment more tolerable.

Participants will:

* Receive up to 6 monthly laser treatments. * Complete surveys asking about pain during and after treatments. * Complete surveys asking about satisfaction with the treatments. * Undergo 2D photography and 3D imaging of treatment areas. * Optionally, receive biopsies of up to 6 treated lesions to investigate characteristics of tumors that respond well to treatment as well as non-respondent tumors.

A vizsgálat 2 csoportja

  • Treated cutaneous neurofibromas (cNFs)Már használt kezelés, összehasonlításként

    Participants will receive treatment with laser at a wavelength of 755 nm to the cutaneous Neurofibromas lesion.

    Kezelés: GentleMax Pro (with skin cooling) és GentleMax Pro (without skin cooling)

  • Control cutaneous neurofibromas (cNFs)Nincs vizsgálati kezelés, összehasonlításként

    A complementary region of cNFs of similar characteristics to the treatment area in the same body region will be selected to serve as an untreated control group.

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
Assessing the Efficacy of Repeat, Monthly Treatments of Alexandrite Laser for NF1 Associated Cutaneous Neurofibromas (cNFs)
A regiszteradat frissítve
2026. június 4.