Phase IV, multicenter, single-arm clinical trial to evaluate the evolution of nail fungal infection in patients treated with DexULac

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Laboratorio Reig Jofre S.A.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

Trial duration

3 Jul 2025 → ongoing

Decision date (initial)

2025-05-06

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

to evaluate the clinical evolution in patients with onychomycosis treated with DexULac® during a period of 48 weeks.

Secondary objectives 7

1. To evaluate the evolution of quality of life in patients with onychomycosis treated with DexULac® during 48 weeks of treatment.
2. To evaluate the clinical success in patients with onychomycosis treated with DexULac® over a period of 48 weeks.
3. To evaluate the clinical improvement in patients with onychomycosis treated with DexULac® over a period of 48 weeks.
4. To evaluate the time required to achieve clinical success in patients with onychomycosis treated with DexULac® over a period of 48 weeks.
5. To evaluate the mycological cure using Polymerase Chain Reaction (PCR) in patients with onychomycosis treated with DexULac® during a period of 48 weeks.
6. To evaluate the evolution of the patient's perception regarding nail alterations during the 48 weeks of treatment with DexULac®.
7. To evaluate the safety profile of treatment with DexULac® for 48 weeks.

Conditions and MedDRA coding

onychomycosis

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. informed consent before starting any procedure related to the study.
2. Adult men and women aged ≥18 to ≤75 years at the time of inclusion
3. Patients diagnosed with mild to moderate distal onychomycosis due to dermatophyte fungi with nail involvement between 10% and 40% at the time of inclusion.
4. Patients diagnosed with onychomycosis in the last 6 months
5. Women of childbearing potential must have a negative urine pregnancy test (fertile is defined from menarche to postmenopause, unless sterilized by hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) and be willing to use contraception. effective from 14 days before the first administration until 4 weeks after the last administration of the investigational medication.

Exclusion criteria 14

1. Hypersensitivity tociclopirox or any component of nail varnish.
2. Pregnant or breastfeeding women
3. Systemic antifungal drugs in the 6 months prior to the start of the study, or need for them.
4. Topical antifungal drugs within 4 weeks prior to the start of the study.
5. Chemotherapy in the 12 weeks prior to the start of the study or need for it.
6. Subjects with a diagnosis of psoriasis or other nail pathology with plate involvement.
7. Patients with uncontrolled diabetes mellitus (DM).
8. Patients with suspected or evidence of severe liver or kidney disease.
9. Acquired Immune Deficiency Syndrome (AIDS) or any other immunodeficiency.
10. Onychomycosis caused by non-dermatophytic yeasts or molds
11. Hyperkeratotic-squamous dermatomycosis of the foot
12. Mucocutaneous candidiasis.
13. Patients with any medical or psychological condition that, in the discretion of the investigator, may interfere with the patient's ability to comply with study procedures
14. Patients who have participated in a clinical trial with an experimental drug or medical device in the last 3 months.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The clinical evolution of onychomycosis will be evaluated through the mean change in the Onychomycosis Severity Index (OSI) from baseline to 12, 24, 36, 48 and 52 weeks.

Secondary endpoints 7

1. The evolution of the quality of life of patients with onychomycosis will be evaluated through the mean change in the Dermatology Life Quality Index (DLQI) from baseline to 12, 36, 48 and 52 weeks. The DLQI will be performed at all study visits until clinical success is achieved or after the end of the follow-up period, which will take place within 4 weeks after the last treatment visit, with a maximum period of 52 weeks.
2. Clinical success in patients with onychomycosis will be evaluated according to the percentage of patients in whom a decrease in the area of ​​the diseased nail has been observed < 10% of the total of the first toe evaluated by the investigator using photographic image from the baseline moment until 12, 24, 36, 48 and 52 weeks.
3. Clinical improvement in patients with onychomycosis will be evaluated according to the percentage of patients in whom at least a 20% decrease in the affected area of ​​the nail of the first toe has been observed evaluated by the investigator using photographic image from the baseline moment until 12, 24, 36, 48 and 52 weeks.
4. The time necessary to achieve clinical success will be evaluated according to the number of weeks of treatment that patients have required to achieve clinical success defined as the reduction of the diseased nail area < 10% of the total of the first toe. foot.
5. Mycological cure will be evaluated by the negativization rate of the PCR test in the 4 weeks after the end of treatment. Therefore, PCR will be performed within 4 weeks of the last treatment visit, which will occur at 52 weeks, or within 4 weeks of the last visit at which clinical success was achieved. In the PCR examination, the presence of dermatophyte fungi that cause onychomycosis will be analyzed as an evaluation criterion.
6. The evolution of the patient's perception regarding nail alterations will be evaluated through the average change in the questionnaire for the subjective evaluation of the patient at 12, 36, 48 and 52 weeks of follow-up.
7. The safety profile of treatment with DexULac® will be evaluated according to the total number and frequency of Adverse Events (AEs), serious AEs (SAEs) and Adverse Reactions (ARs) from baseline to 48 weeks of treatment. In addition, the safety profile will be evaluated according to the number and percentage of patients who have experienced at least one of the mentioned events during the 48 weeks of treatment. The severity and causality of each event will also be evaluated.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Laboratorio Reig Jofre S.A.

Sponsor organisation

Laboratorio Reig Jofre S.A.

Address

Calle Gran Capita 10

City

Sant Joan Despi

Postcode

08970

Country

Spain

Scientific contact point

Organisation

Laboratorio Reig Jofre S.A.

Contact name

Helena Martinez

Public contact point

Organisation

Laboratorio Reig Jofre S.A.

Contact name

Helena Martinez

Locations

1 EU/EEA country · 11 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 12 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications