Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
200
Countries
1
Sites
10
Recurrent herpes labialis (RHL)
To evaluate the efficacy of Lipovir® Gel compared to Zovirax® Cream on patients with RHL
Key facts
- Sponsor
- Laboratorios Ojer Pharma S.L.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 15 Jan 2025 → ongoing
- Decision date (initial)
- 2024-10-07
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Laboratorios Ojer Pharma, S.L.
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To evaluate the efficacy of Lipovir® Gel compared to Zovirax® Cream on patients with RHL
Secondary objectives 2
- To evaluate the local tolerability and acceptability of Lipovir® Gel compared to Zovirax® Cream on patients with RHL.
- To evaluate the safety of Lipovir® Gel compared to Zovirax® Cream on patients with RHL.
Conditions and MedDRA coding
Recurrent herpes labialis (RHL)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 22.0 | LLT | 10082141 | Herpes simplex labialis | 10021881 |
Study design 2 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Run-in phase from the screening visit to the new episode of RHL in the prodrome phase.
|
Not Applicable | None | ||
| 2 | Treatment Phase from the beginning of the new episode of RHL until the lesion is healed or for a maximum of 10 days, whichever occurs first
|
Randomised Controlled | Single | [{"id":175313,"code":2,"name":"Investigator"}] | Lipovir® Gel: Patients will be treated with Lipovir® Gel Zovirax Cream: Patients will be treated with Zovirax cream Placebo: Patients will be treated with Placebo |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Participants must have at least 3 recurrences or herpes labialis within the past year.
- At least half of the recurrences are preceded by recognizable prodromal symptoms, e.g., itching, redness, burning, tingling or a sense of irritation.
- At least half of the prodromes are followed by classical lesions, e.g., ulcer, vesicle, and/or hard crust.
- Age ≥18 years at the time of signing the informed consent form.
- Able to read, understand, and sign the informed consent document.
- Able to understand and follow the study procedures, including completing the study diary.
Exclusion criteria 13
- Participant who is unable or is not expected to reliably comprehend or satisfactorily assess a herpetic lesion.
- Females who are pregnant, breastfeeding, or planning a pregnancy.
- Medical or dermatological conditions that interfere with the treatment or assessment of the herpes lesions (e.g., eczema, psoriasis, acne, seborrhoeic dermatitis).
- Immunocompromised patients or patients receiving immunosuppressive therapy.
- Systemic, severe as well as history of uncontrolled chronic disease or a concurrent clinically significant illness, or medical condition, which in the investigator’s opinion, wouldcontraindicate study participation or compliance with protocol -mandated procedures.
- Known hypersensitivity/allergic reaction to the study drug substance or any of the formulations’ excipients
- Known hypersensitivity to valaciclovir.
- History of herpes keratitis.
- History of unresponsiveness to acyclovir therapy
- Alcohol or drug abuse
- Simultaneous participation in another clinical trial or participation in any clinical trial involving an Investigational medicinal product within 30 days prior to written informed consent for this trial.
- Unlikely to co-operate with the requirements of the study.
- Subjects who have previously enrolled in this study.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Duration of Episode (DOE) assessed by the investigator based on clinical observation and review of participant diary. For vesicular lesions, DOE is the time from treatment initiation to the healing (loss of crust; residual erythema may be present). For not vesicular lesions, DOE is the time from treatment initiation to the return to normal skin or to cessation of symptoms, whichever occurs last.
Secondary endpoints 3
- Local product tolerability self-reported by the participant
- Product acceptability as assessed by the participant
- Incidence of adverse events
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD3681060 · Product
- Active substance
- Aciclovir
- Pharmaceutical form
- GEL
- Route of administration
- CUTANEOUS USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 2 g gram(s)
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- D06BB03 — ACICLOVIR
- Marketing authorisation
- 5651849
- MA holder
- LABORATORIOS OJER PHARMA, S.L
- MA country
- Portugal
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
PRD9970950 · Product
- Active substance
- Aciclovir
- Pharmaceutical form
- CREAM
- Route of administration
- CUTANEOUS USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 2 g gram(s)
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- D06BB03 — ACICLOVIR
- Marketing authorisation
- 56.780
- MA holder
- HALEON SPAIN, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Laboratorios Ojer Pharma S.L.
- Sponsor organisation
- Laboratorios Ojer Pharma S.L.
- Address
- Avenida De Pio XII 4 Piso 1 A
- City
- Pamplona
- Postcode
- 31007
- Country
- Spain
Scientific contact point
- Organisation
- Laboratorios Ojer Pharma S.L.
- Contact name
- Clinical Development Manager
Public contact point
- Organisation
- Laboratorios Ojer Pharma S.L.
- Contact name
- Clinical Development Manager
Third parties 2
| Organisation | City, country | Duties |
|---|---|---|
| Fundacio Privada Dau ORG-100012557
|
Barcelona, Spain | Code 14 |
| Opis S.r.l. ORG-100011127
|
Desio, Italy | On site monitoring, Code 11, Code 12, Code 2, Code 5, Data management, E-data capture, Code 8 |
Locations
1 EU/EEA country · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ongoing, recruiting | 200 | 10 |
| Rest of world | — | 0 | — |
Investigational sites
Centrum Medyczne Mikolowska dr Adam Sipinski
gynecology, Ul. Mikolowska 45/2, 40-065, Katowice
One Day Med Sp. z o.o.
NA, Plac Rodla 8, 70-419, Szczecin
Provita Sp. z o.o.
NA, Ul. Fabryczna 13d, 40-611, Katowice
Specderm Poznanska Sp. j.
NA, Ul. Prezydenta Ryszarda Kaczorowskiego 7/u 50, 15-375, Bialystok
Synexus Polska Sp. z o.o.
NA, Ul. Glogowska 31/33, 60-702, Poznan
Synexus Polska Sp. z o.o.
NA, Ul. Marii Curie-Sklodowskiej 12, 50-381, Wroclaw
Synexus Polska Sp. z o.o.
NA, Ul. Luzycka 3c, 81-537, Gdynia
Synexus Polska Sp. z o.o.
NA, Aleja Najswietszej Maryi Panny 15, 42-202, Czestochowa
Synexus Polska Sp. z o.o.
NA, Ul. Maurycego Beniowskiego 23, 80-382, Gdansk
Synexus Polska Sp. z o.o.
NA, Ul. Skladowa 35, 90-127, Lodz
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Poland | 2025-01-15 | 2025-02-18 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 13 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2023-510338-10-00_FP | 2.0 |
| Protocol (for publication) | D4_Patient facing document_Diary | 2.0 |
| Protocol (for publication) | D4_Patient facing document_Questionnaire | 1 |
| Recruitment arrangements (for publication) | K5_Recruitment material_ FOV SSQ Checklist | 1 |
| Recruitment arrangements (for publication) | N_Recruitment Arrangements_Placeholder_FP | NA |
| Subject information and informed consent form (for publication) | L1 SIS ICF_Main_FP | 3.0 |
| Subject information and informed consent form (for publication) | L2 Pregnant Partner ICF FP | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Lipovir_ENG | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Lipovir_PT | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Zovirax_PL | NA |
| Synopsis of the protocol (for publication) | D2_Protocol synopsis ENG_2023-510338-10-00 | 2.0 |
| Synopsis of the protocol (for publication) | D2_Protocol synopsis PL_2023-510338-10-00 | 2.0 |
| Synopsis of the protocol (for publication) | D3 Protocol_Lay Synopsis_PL_2023-510338-10-00 | 2.0 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-12 | Poland | Acceptable 2024-09-30
|
2024-10-07 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-11-25 | Poland | Acceptable 2024-09-30
|
2024-11-25 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-01-19 | Poland | Acceptable 2026-03-27
|
2026-03-31 |