Non-dermatophyte Onychomycosis Clinical Trial
Official title:
Comparison of the Efficacy and Safety Between Long-pulsed Nd:YAG, Amorolfine and Combination of Long-pulsed Nd:YAG and Amorolfine in Treating Non-dermatophyte and Mixed-infection Onychomycosis
Verified date | September 2021 |
Source | Mahidol University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to compare the efficacy and safety of amorolfine, long-pulsed Nd:YAG laser and the combination between amorolfine and long-pulsed Nd:YAG in treating the non-dermatophyte and mixed-infection onychomycosis.
Status | Completed |
Enrollment | 60 |
Est. completion date | December 2019 |
Est. primary completion date | June 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. The patients aged more than 18 years old. 2. The patients were diagnosed with non-dermatophytes or mixed-infection onychomycosis from both KOH examination and fungal cultured. 3. The patients did not have any prior anti-fungal treatment within 6 months 4. The patients did not receive any vasodilator drugs or isotretinoin within 6 months 5. The patients who are willing to participate, and accept the methods and risk Exclusion Criteria: 1. The patients who suffered other medical dermatologic condition associated with onychomycosis such as psoriasis, paronychia etc. 2. The patients who took immunosuppressive drugs, or the immunocompromised host. 3. The patients who had severe vascular disease, such as severe DVT, or poor capillary refill time. 4. The patients who had onychomycosis which involved in nail matrix. 5. Pregnancy or lactation. 6. The patients who had problems communication or have difficulty travel to the faculty for the checkup. |
Country | Name | City | State |
---|---|---|---|
Thailand | Department of Dermatology Siriraj Hospital | Bangkoknoi | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Mahidol University |
Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mycological cure rate in patients with onychomycosis after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment | Mycological cure defined as negative Mycological culture | 6 months after treatment | |
Secondary | Mycological cure rate in patients with onychomycosis after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment | Mycological cure rate | 1 month after treatment | |
Secondary | Mycological cure rate in patients with onychomycosis after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment | Mycological cure rate | 2 months after treatment | |
Secondary | Mycological cure rate in patients with onychomycosis after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment | Mycological cure rate | 3 months after treatment | |
Secondary | number of participants who develop paronychia after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment | number of participants | 1 month after treatment | |
Secondary | number of participants who develop paronychia after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment | number of participants | 2 months after treatment | |
Secondary | number of participants who develop paronychia after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment | number of participants | 3 months after treatment | |
Secondary | number of participants who develop paronychia after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment | number of participants | 6 months after treatment | |
Secondary | pain score in participants who received long-pulsed Nd:YAG and the adjunct treatment | pain score | 1 month after treatment | |
Secondary | pain score in participants who received long-pulsed Nd:YAG and the adjunct treatment | pain score | 2 months after treatment | |
Secondary | pain score in participants who received long-pulsed Nd:YAG and the adjunct treatment | pain score | 3 months after treatment | |
Secondary | pain score in participants who received long-pulsed Nd:YAG and the adjunct treatment | pain score | 4 months after treatment | |
Secondary | Depth of nail involvement of onychomycosis after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment | Depth of nail | 1 month after treatment | |
Secondary | Depth of nail involvement of onychomycosis after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment | Depth of nail | 2 months after treatment | |
Secondary | Depth of nail involvement of onychomycosis after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment | Depth of nail | 3 months after treatment | |
Secondary | Depth of nail involvement of onychomycosis after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment | Depth of nail | 6 months after treatment |