MILD TO SEVERE PAPULOPUSTULAR ACNE MedDRA version: 17.1 Level: LLT Classification code 10000519 Term: Acne vulgaris System Organ Class: 100000004858
Conditions
Interventions
Trade Name: Tyrosur® Gel
Product Name: Tyrosur® 0,1% Gel
Pharmaceutical Form: Gel
INN or Proposed INN: Tyrothricin
CAS Number: 1404-88-2
Other descriptive name: TYROTHRICIN
Concentration unit: mg/g m
Sponsors
Clinical Research Center for Hair and Skin Science
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Female or male patients 18 - 25 years of age; • Fitzpatrick skin phototype of I-III [31]; • Written informed consent of the patients and of the parents/legal guardians of minor patients (as applicable); • Clinical diagnosis of facial mild to severe papulopustular acne with comparable in appearance on both sides of the face; • The number of inflammatory lesions or non-inflammatory lesions on one half-face must not be greater than twice the number on the other half-face; • Investigative Static Global Assessment Score (ISGA) of 2 (mild) to 4 (severe); • Total facial acne inflammatory lesion count (papules and pustules) of no less than 10 but no more than 50; • Total facial acne non-inflammatory lesion count (open and closed comedones) of no less than 10 but no more than 100; • Female subjects of childbearing potential must have a reliable negative pregnancy test at baseline and must not be breast feeding. Women of childbearing potential participating in the trial must use highly effective form1 of contraception, if use of a hormonal method, the same drug has to be used since at least 6 month. • Subjects accepting not to use any antimicrobial topical products (shampoo, soap acne preparation) as well as oral and over the counter (OTC) acne products. • Non-smokers Are the trial subjects under 18? no 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 24 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • More than 2 nodulo-cystic lesions on each side of the face; • Other dermatological disorder like: rosacea, atopic dermatitis, perioral dermatitis and psoriasis that may distort the assessment of acne or the assessment of tolerability; • Planned absences during the course of the trial; • Known hypersensitivity against or previous allergic reaction to tyrothricin, clindamycin, lincomycin, benzoyl peroxide or any other excipient of the trial medications; • Previous smoothing or ablative procedures (cryotherapy, fruit acid / TCA peelings, Fraxel Laser etc.) within 3 month prior baseline; • Intake or use of the following medication : • Systemic isotretinoin (within the last 6 months prior baseline); • Systemic antibiotics (within the last 4 weeks prior baseline); • Systemic corticosteroids (within the last 4 weeks prior baseline); • Systemic non-steroidal anti-inflammatory drugs in dosage for the treatment of inflammations (within the last 4 weeks prior baseline); • Topical retinoids (extensive application over the body or in the face within the last 2 weeks prior baseline); • Topical corticosteroids (extensive application over the body or in the face within the last 2 weeks prior baseline); • Topical use of non-steroidal anti-inflammatory drugs for the treatment of inflammations (extensive application over the body or in the face within the last 2 weeks prior baseline); • Medications that are reported to exacerbate acne (eg, high-doses of certain vitamins such as vitamin D, vitamin A, and vitamins B2, B6, and B12; haloperidol; halogens such as iodide and bromide; lithium; hydantoin; and phenobarbital) within the last 3 months prior baseline; • Using the following types of facial products within 2 weeks prior baseline: astringents, toners, abrasives, facial peels containing glycolic or other acids, masks, washes, soaps or gels containing BPO, sulfacetamide sodium or salicylic acid, non-mild facial cleansers, or moisturizers that contain retinol, salicylic acid, or a- or ß-hydroxy acids; • Any severe acute or chronic diseases; • Participation in a clinical trial in the last 30 days prior baseline or at the same time; • Intensive UV-exposition or regular visits of solariums within the last 4 weeks prior baseline or during the course of the trial; • Persons who are institutionalized because of legal or regulatory order.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this trial is to evaluate the efficacy and the tolerability of topically applied 0.1% tyrothricin (Tyrosur® Gel) in patients with mild to severe facial papulopustular acne in comparison to a combination of clindamycin and benzoyl peroxide or to benzoyl peroxide alone;Secondary Objective: Not applicable;Primary end point(s): - Change of inflammatory lesion count between Baseline and each visit (7 visits) - Change of non-inflammatory lesion count between Baseline and each visit (7 visits) - Change of total lesion count between Baseline and each visit (7 visits) - Change of ISGA score between Baseline and each visit (7 visits) - Change of follicular fluorescence between Baseline and each visit (7 visits) - Change of sebum content between Baseline and each visit (7 visits);Timepoint(s) of evaluation of this end point: End of study and trend of the change in variables during study course (Visit 1-7). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Germany
Contacts
Public ContactDr. Sabine Fimmel
Charité-Universitätsmedizin Berlin, Department of
Outcome results
None listed