Health TrialsbyHealthPanel

Systemic Antifungal Plus Q-Switched Nd:YAG Laser for Onychomycosis

ConditionOnychomycosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssiut University

About this trial

This randomized controlled trial aims to compare the efficacy and safety of systemic terbinafine combined with Q-switched Nd:YAG laser versus systemic terbinafine alone in the treatment of onychomycosis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

- Age 18 years or older

Mycologically confirmed onychomycosis by direct microscopy with potassium hydroxide and/or fungal culture

Willing to receive systemic antifungal therapy

Willing to undergo Q-switched Nd:YAG laser treatment

Disqualifiers

- Pregnancy or lactation

Planned pregnancy during treatment

Nail disorders such as psoriasis, eczema, or lichen planus

Significant hepatic disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • Terbinafine

    Drug

    Oral terbinafine 250 mg once daily for 6 weeks (fingernails) or 12 weeks (toenails).

  • Q-switched Nd:YAG laser

    Device

    Q-switched Nd:YAG laser (1064 nm) applied to the affected nail plate, 4 passes per session, every 2 weeks for 6 sessions.

Treatment groups

97 Participants
are divided into 2 treatment groups
Group A: Terbinafine plus Q-switched Nd:YAG laserExperimental treatment 2 interventions
Group B: Terbinafine aloneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Onychomycosis Severity Index

Mean change in Onychomycosis Severity Index (OSI) score (range 0 to 35, higher scores indicate more severe disease) from baseline to end of treatment.

Time frame
At 3 months

Secondary outcomes

1

Mycological cure rate

Number of patients with negative direct microscopy and negative fungal culture at the end of treatment.

Time frame
At 3 months
2

Clinical cure rate

Number of patients achieving complete or near-complete normalization of the treated nail appearance.

Time frame
At 3 months
3

Patient satisfaction score

Mean patient satisfaction score using a quartile grading system (0 = unsatisfied to 3 = very satisfied).

Time frame
At 3 months
4

Number of patients with treatment-related adverse events

Number of patients who experience any treatment-related adverse events.

Time frame
At 3 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: