Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 74 of 112 for:    acyclovir

Trial on Efficacy and Safety of Pritelivir Ointment for Treatment of Labial Herpes (LipP1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02871492
Recruitment Status : Completed
First Posted : August 18, 2016
Last Update Posted : January 10, 2018
Sponsor:
Collaborator:
Novella Clinical
Information provided by (Responsible Party):
AiCuris Anti-infective Cures GmbH

Brief Summary:

Randomized, double-blind, multi-center, three arm parallel group, comparative trial to assess pritelivir ointment safety and efficacy, ie, proportion of subjects with non-ulcerative lesions, in adult subjects with recurrent herpes labialis (RHL) in comparison with placebo or Zovirax® Cream. The start of treatment with trial medication will be initiated by the subject within one hour of noticing the first sign or symptom (eg, prodrome) of a recurrence of herpes labialis. Trial medication will be applied to the affected area 5 times daily for 4 days.

After self-initiation of treatment with trial medication subjects will be assessed daily by the Investigator until complete healing for a maximum of 13 days.

Subjects will document application of trial medication and the status of their lesion in a diary. There will also be blood sampling, ECG measurement and physical examination performed at the investigational site.


Condition or disease Intervention/treatment Phase
Herpes Labialis Drug: Pritelivir 5% w/w ointment Drug: Pritelivir ointment matching placebo Drug: Zovirax® cream Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 362 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Multi-center, Three Arm (Pritelivir, Placebo and Zovirax®) Parallel Group, Comparative Trial to Assess the Efficacy and Safety of Pritelivir 5% w/w Ointment for the Treatment of Recurrent Herpes Labialis in Adults - LipP1
Actual Study Start Date : November 29, 2016
Actual Primary Completion Date : August 29, 2017
Actual Study Completion Date : October 13, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cold Sores

Arm Intervention/treatment
Experimental: Pritelivir 5% w/w ointment
Topical treatment (20 applications), 5 times daily for 4 days
Drug: Pritelivir 5% w/w ointment
Placebo Comparator: Pritelivir ointment matching placebo
Topical treatment (20 applications), 5 times daily for 4 days
Drug: Pritelivir ointment matching placebo
Active Comparator: Zovirax® cream
Topical treatment (20 applications), 5 times daily for 4 days
Drug: Zovirax® cream



Primary Outcome Measures :
  1. Efficacy measured by proportion of subjects with non-ulcerative lesions [ Time Frame: 4 days ]

Secondary Outcome Measures :
  1. Efficacy measured by time to lesion healing [ Time Frame: 13 days ]
  2. Efficacy measured by pain rate [ Time Frame: 13 days ]
    Number of days with pain at lesion site relative to the total number of days with analyzable pain through daily subject self- assessment

  3. Efficacy measured by time to pain cessation [ Time Frame: 13 days ]
  4. Efficacy measured by average pain score [ Time Frame: 13 days ]
    Using a single-dimensional scale assessing pain intensity at lesion site: NUMERIC RATING SCALE (NRS)

  5. Efficacy measured by maximum lesion area [ Time Frame: 13 days ]
    Length x width in cm^2 of ulcerative lesions during the vesicular, ulcerative and hard crust stages

  6. Efficacy measured by duration of lesion tenderness [ Time Frame: 13 days ]
  7. Safety measured by adverse events [ Time Frame: 13 days ]
    Nature, frequency, duration, severity of and discontinuation due to adverse events (AEs), seriousness, causality and outcome

  8. Safety measured by haematology [ Time Frame: 13 days ]
  9. Safety measured by vital signs [ Time Frame: 13 days ]
    Systolic and diastolic blood pressure, pulse rate

  10. Safety measured by ECG [ Time Frame: 13 days ]
    Standard 12-lead electrocardiogram

  11. Safety measured by physical examination [ Time Frame: 13 days ]
    Detailed general physical examination of the whole body

  12. Efficacy measured by cumulative lesion area [ Time Frame: 13 days ]
    Sum of daily maximum lesion areas in cm^2

  13. Safety measured by clinical chemistry [ Time Frame: 13 days ]
  14. Safety measured by urinalysis [ Time Frame: 13 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy men and women of any ethnic group aged ≥18 years ;
  • Subjects should have experienced ≥4 recurrences of herpes labialis in the previous 12-months period;
  • Subjects should have experienced prodromal symptoms in at least 50% of recurrent Herpes labialis (rHL) episodes and should have developed ulcerative lesions that have progressed through vesicle, ulcer, and crust stages in at least 50% of the episodes;
  • Willingness not to use any topical application (such as cosmetics, lip balm, sunscreens etc…) other than the trial medication in the area of lesion development from start of prodromal symptoms to complete healing;
  • Willingness not to use any systemic and topical anti-Herpes Simplex Virus (HSV) agent during the trial participation including prescription and OTC products;
  • Willingness not to use any systemic, anti-inflammatory or analgesic agents from start of prodromal symptoms to healing;
  • Willingness to refrain from mechanical disruption (ie, scrubbing, lancing, shaving) of the prodromal area or lesion after start of treatment with trial medication until end of the trial participation;
  • Women of child bearing potential and males must use adequate contraception;
  • Subject must give written informed consent.
  • Subjects with current lesion may be enrolled, but they must not treat the lesion present at screening/randomization with the trial medication; they should be instructed to wait for their next subsequent lesion

Exclusion Criteria:

  • Known intolerance to pritelivir or any of the ointment ingredients;
  • Known intolerance to Zovirax® Cream or any of the ingredients (ie, acyclovir, cetostearyl alcohol, mineral oil, poloxamer 407, propylene glycol, sodium lauryl sulfate, and white petrolatum) or valacyclovir;
  • Any skin conditions that could interfere with the assessment of herpes labialis recurrences (eg, eczema, psoriasis, acne etc…)
  • Any other condition which in the opinion of the Investigator would interfere with successful completion of this clinical trial
  • Pregnant and/or breastfeeding women
  • Participation in any investigational drug trial within the last 30 days before randomization for this clinical trial
  • Previous treatment with pritelivir tablets
  • Previous participation in a HSV vaccination Trial unless having received placebo.
  • Clinically relevant ECG abnormalities (eg, QTc according to Fridericia: QTcF > 450 ms for males and QTcF > 470 ms for females; PR > 220 ms) at screening.
  • Clinically relevant abnormalities in laboratory indices at screening which in the opinion of the investigator might have an impact on the safety and evaluability of the subject.
  • Known chronic infections which in the opinion of the investigator might have an impact on the safety and evaluability of the subject.
  • Evidence of active malignancy or immunodeficiency disease, or require chronic use of immunosuppressive drugs (eg, systemic steroids) or topical steroids, or chronically use antiviral medication with activity against HSV.
  • HIV positive based on screening labs.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02871492


Locations
Layout table for location information
United States, Arizona
Scottsdale, Arizona, United States, 85251
United States, California
Santa Rosa, California, United States, 95405
United States, Florida
Pinellas Park, Florida, United States, 33781
United States, Minnesota
Edina, Minnesota, United States, 55435
United States, Missouri
Saint Louis, Missouri, United States, 63141
United States, Ohio
Akron, Ohio, United States, 44311
Cincinnati, Ohio, United States, 45236
United States, South Carolina
Anderson, South Carolina, United States, 29621
Greer, South Carolina, United States, 29650
United States, Texas
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
AiCuris Anti-infective Cures GmbH
Novella Clinical

Layout table for additonal information
Responsible Party: AiCuris Anti-infective Cures GmbH
ClinicalTrials.gov Identifier: NCT02871492     History of Changes
Other Study ID Numbers: AIC316-02-II-01
First Posted: August 18, 2016    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Acyclovir
Herpes Labialis
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Skin Diseases, Infectious
Skin Diseases
Pritelivir
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action