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: 12.1 Level: LLT Classification code 10019942 Term: Herpes labialis
Conditions
Interventions
Product Name: Muxan 0.5 %
Pharmaceutical Form: Ointment
INN or Proposed INN: Tosylchloramid-Natrium
CAS Number: 127-65-1
Other descriptive name: chloramine-T
Concentration unit: % percent
Concentrati
Sponsors
Engelhard Arzneimittel GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate superiority in efficacy of Muxan either 0.5 % or 1 % for the treatment of acute herpes labialis episodes compared to vehicle regarding the reduction of subjectively perceived symptoms (symptom score). ;Primary end point(s): ;Secondary Objective: - Comparison of Muxan 0.5 % versus vehicle and Muxan 1 % versus vehicle with respect to duration of herpes episode (Time to healing, lesion stage assessement by patient). - Comparison of Muxan 0.5 % versus vehicle and Muxan 1 % versus vehicle with respect to duration of herpes episode (Time to healing, lesion stage assessment by physician). - Comparison of Muxan 0.5 % versus vehicle and Muxan 1 % versus vehicle with respect to physician’s severity assessment. - Comparison of Muxan 0.5 % versus vehicle and Muxan 1 % versus vehicle with respect to proportion of crust development and duration of crust. - Comparison of Muxan 0.5 % versus vehicle and Muxan 1 % versus vehicle with respect to the individual symptom scores of patient’s assessments (itching, tingling, burning sensation, pain, tautness and swelling). - VISIA photographs for documentation of altogether 15 patients of each visit day (5 patients of each treatment arm). | — |
Countries
Germany
Outcome results
None listed