Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01180491
Other study ID # K101-50
Secondary ID
Status Completed
Phase N/A
First received August 10, 2010
Last updated June 25, 2013
Start date September 2010
Est. completion date November 2010

Study information

Verified date June 2013
Source Moberg Derma AB
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to further evaluate and document early visible effects on nail appearance of topical K101.


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date November 2010
Est. primary completion date November 2010
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Male or female patients aged 18 years or older

- 25%-75% of the target nail altered as a result of onychomycosis

- Signed written informed consent

Exclusion criteria

- Proximal subungual onychomycosis

- Patient who has been previously randomized to treatment in the phase III study K70-2 investigating K101

- Other conditions known to cause abnormal nail appearance

- Use of topical (1 month before screening) and/or systemic (3 months before screening) antifungal medication.

- Participation in another clinical study with an investigational drug or device during the previous 4 weeks before enrolment.

- Known allergy to any of the tested treatment products

Study Design

N/A


Related Conditions & MeSH terms


Intervention

Device:
K101 nail solution


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Moberg Derma AB

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients experiencing at least some improvement of the target nail (scoring 2 or more according to Global Assessment Scale) after 8 weeks treatment.
See also
  Status Clinical Trial Phase
Completed NCT03098615 - Study Evaluating the Effect of Jublia on Dermatophytomas Phase 4
Recruiting NCT01666002 - Treatment of Onychomycosis Using a 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser N/A
Terminated NCT01208168 - Safety & Efficacy of NAB001 in the Treatment of Mild to Moderate Onychomycosis of the Toenails Phase 3
Terminated NCT01208129 - Safety and Efficacy of NAB001 in the Treatment of Mild to Moderate Onychomycosis of the Toenails Phase 3
Completed NCT00385502 - A Trial of the Safety and Efficacy of EcoNailâ„¢ in the Treatment of Fungus Infections of the Great Toenail Phase 2
Completed NCT00253305 - Topical Gel Anti-Fungal Agent for Tinea Unguium Phase 2
Not yet recruiting NCT05809297 - Diode Laser and Photodynamic Therapy Vs. Ciclopirox. Phase 4
Completed NCT03405818 - An Evaluation of the Safety and Pharmacokinetics of Tavaborole Topical Solution for the Treatment of Fungal Disease of the Toenail in Children and Adolescents Phase 4
Completed NCT02588599 - A Retrospective Analysis of the Effects of Low Level Laser Therapy on Toenail Onychomycosis N/A
Recruiting NCT02436291 - Evaluation of the Efficacy of CURE-EX Treatment in Onychomycosis Phase 4
Completed NCT01851590 - Resin vs. Amorolfine vs. Terbinafine Treatment in Onychomycosis Phase 4
Completed NCT01452490 - Diode Laser Treatment of Onychomycosis N/A
Withdrawn NCT00938925 - Effectiveness of Podiatry Care on Onychomycosis (EPOCAON) N/A
Recruiting NCT00808366 - Efficacy and Safety of RV4104A Ointment in Onychomycosis N/A
Completed NCT00781820 - Comparative Efficacy of Bifonazole Cream vs Placebo After Nail Ablation With Urea Paste Phase 3
Completed NCT00768768 - Iontophoretic Application of Terbinafine Gel to the Large Toe Nail Phase 1
Completed NCT00777868 - A Dose-Ranging Study Evaluating the Safety and Efficacy of IDP-108 in Patients With Onychomycosis Phase 2
Recruiting NCT06074315 - Evaluation of the Effectiveness of Nail Genesis DLSO Product for Onychomycosis N/A
Completed NCT01039883 - A Study to Compare the Blood Levels of Albaconazole in Healthy Subjects Who Have Received a Single Dose of 400 mg Albaconazole as a Tablet Versus Albaconazole as a Capsule Phase 1
Suspended NCT05491603 - A Trial to Evaluate the Safety and Efficacy of DBI-001 Gel, DBI-002 Gel, and Aqueous Gel in Subjects With Onychomycosis Phase 2