1320 nm Nd:YAG Laser for Improving the Appearance of Onychomycosis

NCT01498393 | Completed Phase 1 DMC

• 1 other identifier: 20118536
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical study is to improve the appearance of onychomycosis and morphology of the nail (fungal infection). The researcher can use a light based therapy to gently heat the toenail infected with fungus to improve the appearance of onychomycosis.

Conditions

Fungal Nail Infection

Keywords

fungal nail

Outcome Measures

Primary Outcomes (1)

• Improving the Appearance of fungal nail

  Laser treatment to Improve the Appearance of Onychomycosis

  6 months

Study Arms (1)

Laser treatment

OTHER

Laser treatment to Improve the Appearance of Onychomycosis

Device: Laser treatment

Interventions

Laser treatment DEVICE

Laser treatment to Improve the Appearance of Onychomycosis

Laser treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult Male/ female has been diagnose with fungal nail infection on both great toenails.

You may not qualify if:

• Any other toenail disease including, but not limited to psoriasis, lichen planus, pachyonychia congenita, etc. as determined by the investigator.
• Excessively thick or hypertrophic nails.
• Subjects with diabetes.
• Subjects that are pregnant
• Receipt of any topical therapy for onychomycosis (i.e. antifungal) within 2 weeks of enrollment, systemic therapy for onychomycosis (i.e. antifungal) within 3 months of enrollment, or any other procedures done on the test area within 6 months of enrollment.
• Subjects with impaired immune systems including, but not limited to HIV, transplant patients on immunosuppression, etc.
• Current or history of psychiatric disease that would interfere with ability to comply with the study protocol or give informed consent.
• History of alcohol or drug abuse that would interfere with ability to comply with the study protocol.

Sponsors & Collaborators

• University of California, Irvine: lead
• Beckman Laser Institute University of California Irvine: collaborator

Study Sites (1)

Beckman Laser Institute

Irvine, California, 92612, United States

Location

Related Publications (1)

• Ortiz AE, Truong S, Serowka K, Kelly KM. A 1,320-nm Nd: YAG laser for improving the appearance of onychomycosis. Dermatol Surg. 2014 Dec;40(12):1356-60. doi: 10.1097/DSS.0000000000000189.

  PMID: 25357174 RESULT

Related Links

• A 1,320-nm Nd: YAG laser for improving the appearance of onychomycosis

MeSH Terms

Conditions

Onychomycosis

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Kristen Kelly, MD

  Beckman Laser Institute, UCI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kristen Kelly, M.D., Professor Departments of Dermatology and Surgery

Study Record Dates

• First Submitted: December 20, 2011
• First Posted: December 23, 2011
• Study Start: December 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 1, 2022

Record last verified: 2022-10

Locations

US (1)