A phase III, multi-center, double-blind, randomized, vehicle controlled trial in a parallel-group design to evaluate the efficacy and safety of two formulations of Muxan containing 0.5 % or 1 % chloramine-T compared to vehicle in patients aged 12 years or older with acute herpes labialis

• Conditions: Male or female patients, aged 12 years or older (first part of the trial: only patients aged 18 years or older), with an adequate history of recurrent herpes labialis and an acute episode of herpes labialis will be investigated.; MedDRA version: 12.1Level: LLTClassification code 10019942Term: Herpes labialis

• Registration Number: EUCTR2010-021144-17-DE
• Lead Sponsor: Engelhard Arzneimittel GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-13
• Last Update Posted: 22 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• males and females aged 12 years or older (first part of the trial: only patients aged
18 years or older in Germany; second part of the trial: patients 12 years or older
expected not earlier than 2012) with recurrent herpes labialis episodes, at least 2
episodes of herpes lesions in the last year;
• acute herpes labialis episode;
• patients have to be present at the clinical site after onset of herpes labialis
symptoms within the next 16h to initiate treatment;
• two symptoms of the subjective assessment of herpes symptoms” have to be
assessed with score 1 or one symptom with score 2 by the patients;
• history of at least 50 % of herpes labialis episodes producing lesion with blister;
• the patient or his/her legal representative must give written informed consent,
after having been informed orally and in writing about the anticipated benefits and
potential risks of the trial, as well as about details of the insurance taken out to
cover the patients participating in the trial;
• female volunteers of childbearing potential must either be surgically sterile
(hysterectomy or tubal ligation) or agree to use a reliable method of contraception
with a failure rate of less than 1 % per year when used consistently and correctly
such as implants, injectables, combined oral contraceptives, some intra uterine
devices [IUDs], sexual abstinence or vasectomized partner.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• acne, suntan, eczema, hyperpigmentation, piercing or tattoos in the affected area;
• evidence of drug or alcohol abuse;
• history of positive result for hepatitis B surface antigen, hepatitis C virus, or HIV;
• pregnancy or nursing;
• multiple simultaneous lesions;
• current significant skin disease within the affected area;
• area of herpes labialis greater than 3 cm in diameter;
• lesions that have already formed an ulcer or a crust (lesion stage score > 4);
• known allergic reactions (intolerance or hypersensitivity) to components of the
investigational products (e.g. against chloramine-T);
• treatment with systemic or locally acting medications which might counter or
influence the trial aim within two weeks before the baseline visit (e.g.
antihistamines or glucocorticosteroids);
• cytotoxic, immunosuppressive or immunomodifying drugs within 3 month;
• use of an anti-viral medication in the preceding 30 days;
• congenital, acquired or corticosteroid-induced immunodeficiency;
• symptoms of a clinically significant illness that may influence the outcome of the
trial in the four weeks before and during the trial (e.g. eczema, psoriasis, albinism,
or chronic vesiculobullous disorders);
• in the opinion of the investigator or physician performing the initial examination the
patient should not participate in the clinical trial, e.g. due to probable
noncompliance or inability to understand the trial and give adequate informed
consent;
• participation in the treatment phase of another clinical trial within the last four
weeks prior to the first administration of investigational drug in this clinical trial;
• patient is institutionalized because of legal or regulatory order.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified