Study to evaluate the efficacy and safety of P-3058 10% solution in the treatment of nails affected by fungi
- Conditions
- Mild to moderate distal subungual Onychomycosis caused by DermatophytesMedDRA version: 18.1Level: PTClassification code 10030338Term: OnychomycosisSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2015-000561-31-GR
- Lead Sponsor
- Polichem S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 840
1. Written informed consent before starting any study related
procedures.
2. Patients aged 12 to 80 years old of any race.
3. Males or females.
4. Outpatients.
5. Clinically diagnosed mild-to-moderate distal lateral subungual
onychomycosis (DLSO) of at least one big toenail (the target
nail) at the Screening visit (V1), confirmed by the Independent
Panel of Reviewers.
6. Patients with onychomycosis involving = 20% to = 50% of the
area of the target big toenail.
7. Patients with a positive KOH examination in the screening target
big toenail sample.
8. Patients with positive culture for dermatophyte(s) or positive
mixed dermatophyte(s)/Candida culture in the screening target
big toenail sample.
9. Evidence of target big toenail growth reported by the patient
defined as at least monthly nail clipping.
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 420
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 320
1. Woman who is pregnant, nursing an infant, or planning a
pregnancy during the study period
2. Patients with history of allergic reactions to terbinafine or its
excipients.
3. Use of any investigational drug/device or participation in a
previous clinical trial within four weeks prior to Screening visit (V1).
4. Patients using nail polish or other nail cosmetic product on the
concerned nails from at least 24 hours prior to Screening visit
(V1) until the end of the study.
5. Use of systemic antifungal drugs in the 24 weeks prior to
Screening visit (V1) or non–responsive to systemic antifungal
therapy for onychomycosis.
6. Nail application of topical antifungal drugs or device in the 4
weeks prior to Screening visit (V1).
7. Presence of any nail infections other than dermatophyte as
determined by the Investigator (Candida onychomycosis
infection concurrent with positive dermatophyte culture is
acceptable).
8. Presence of onychodystrophy that could interfere with clinical
assessments as determined by the Investigator.
9. Presence of yellow spikes” (defined as longitudinal streak
extending from the free edge of the nail to the proximal edge) on
the target nail.
10. Presence of dermatophytoma (defined as thick masses of fungal
hyphae and necrotic keratin between the nail plate and nail bed)
on the target nail.
11. Presence of nail thickness exceeding 2 mm.
12. Patients with proximal subungual involvement (marker of
immunosuppressed patient).
13. Patients with severe plantar or moccasin tinea pedis (defined by
blistering, pustules or inability to ambulate).
14. Patients with nail abnormalities due to conditions like psoriasis,
lichen planus, immune dysfunction, collagen-vascular diseases,
peripheral vascular disease.
15. Patients with life expectancy less than 2 years.
16. Chemotherapy, immunosuppressive therapy in the 12 weeks prior
to Screening visit (V1).
17. Systemic corticosteroids, antimetabolites and immune-stimulants
therapy in the 4 weeks prior to Screening visit (V1).
18. HIV infection or any other immunodeficiency.
19. Alcohol or substance abuse.
20. Patients/parents (or legal guardian) unable to understand the
procedures and purposes of the study.
Exclusion criteria during the study:
• Any topical product on nails is not allowed. Subjects with
cutaneous fungal infections who may require treatment during the
trial should be excluded or treated prior to enrolment.
• Evidence of pregnancy will result in cessation of treatment and the
pregnancy outcome will be followed up until delivery.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of P-3058 in the treatment of onychomycosis.;Secondary Objective: To evaluate the overall safety and the tolerability of P-3058. ;Primary end point(s): Complete cure rate at Week 60 (12 weeks after 48-week treatment<br>course, V8) defined as composite of negative KOH microscopy<br>and negative culture for dermatophytes and no residual clinical<br>involvement (nail totally clear) of the target nail.;Timepoint(s) of evaluation of this end point: Week 60
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • Responder rate at Week 60 (V8) defined as negative KOH<br>microscopy and negative culture for dermatophytes and = 10%<br>residual involvement of the target toenail.<br>• Negative culture rate for dermatophytes of the target nail at Week<br>60 (V8).<br>• Mycological cure defined as negative KOH microscopy and<br>negative culture for dermatophytes of the target nail at Week 60<br>(V8).<br>• Overall safety by recording any AE during the entire study<br>duration and the local tolerability by means of severity scores for<br>skin irritation.<br><br>Supportive end-point<br>• Onychomycosis quality of life (ONYCHO © -Toenail, Mapi<br>Research Trust): change from baseline to Week 60 (V8).;Timepoint(s) of evaluation of this end point: Week 60.