ACICLOVIR for Recurrent herpes labialis | Herpes simplex labialis

Inclusion criteria

• {"criterion_text":"- Participants must have at least 3 recurrences or herpes labialis within the past year.\n- At least half of the recurrences are preceded by recognizable prodromal symptoms, e.g., itching, redness, burning, tingling or a sense of irritation.\n- At least half of the prodromes are followed by classical lesions, e.g., ulcer, vesicle, and/or hard crust.\n- Age ≥18 years at the time of signing the informed consent form.\n- Able to read, understand, and sign the informed consent document.\n- Able to understand and follow the study procedures, including completing the study diary."}

Exclusion criteria

• {"criterion_text":"- Participant who is unable or is not expected to reliably comprehend or satisfactorily assess a herpetic lesion.\n- Alcohol or drug abuse\n- 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.\n- Unlikely to co-operate with the requirements of the study.\n- Subjects who have previously enrolled in this study.\n- Females who are pregnant, breastfeeding, or planning a pregnancy.\n- Medical or dermatological conditions that interfere with the treatment or assessment of the herpes lesions (e.g., eczema, psoriasis, acne, seborrhoeic dermatitis).\n- Immunocompromised patients or patients receiving immunosuppressive therapy.\n- 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.\n- Known hypersensitivity/allergic reaction to the study drug substance or any of the formulations’ excipients\n- Known hypersensitivity to valaciclovir.\n- History of herpes keratitis.\n- History of unresponsiveness to acyclovir therapy"}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"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

• {"endpoint_text":"- Local product tolerability self-reported by the participant","definition_or_measurement_approach":"Self-reported tolerability assessed by the participant (as stated)."}
• {"endpoint_text":"- Product acceptability as assessed by the participant","definition_or_measurement_approach":"Acceptability assessment as reported by the participant (as stated)."}
• {"endpoint_text":"- Incidence of adverse events","definition_or_measurement_approach":""}

Poland

Earliest CTIS Part Ii Submission Date

25-08-2024

Latest Decision Or Authorization Date

31-03-2026

Processing Time Days

583

Number Of Sites

10

Number Of Participants

200

Primary sponsor

Full Name

Laboratorios Ojer Pharma S.L.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Spain

Third parties

• {"country":"Spain","full_name":"Fundacio Privada Dau","duties_or_roles":"code:14","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Italy","full_name":"Opis S.r.l.","duties_or_roles":"codes:1,11,12,2,5,6,7,8","organisation_type":"Pharmaceutical company"}