Moderate to severe acne MedDRA version: 14.1 Level: HLT Classification code 10000497 Term: Acnes System Organ Class: 100000004858
Conditions
Interventions
Product Name: Neramexane Mesylate Gel 0.5%
Pharmaceutical Form: Gel
INN or Proposed INN: Neramexane Mesylate
CAS Number: 457068-92-7
Other descriptive name: 1-amino-1,3,3,5,5-pentamethylcyclohexane me
Sponsors
Merz Pharmaceuticals GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For Stage 1 only: 1. Male or female of any ethnic origin 18 to 65 years of age. For Stage 2 only: 2. Male or female of any ethnic origin 12 to 65 years of age. For Stage 1 and 2: 3. Subject must sign the informed consent. For minor (less than 18 years), the legally acceptable representative (i.e. parents or guardian) must complete the informed consent process and sign the informed consent form AND the subject must complete the assent process and sign the appropriate form (if age appropriate). 4. Understanding of study procedures and willingness to abide by all procedures during the course of the study. 5. Moderate to Severe Acne on the face with a combination of inflammatory and non-inflammatory lesions. 6. Has an inflammatory Acne lesion count (papules and pustules) of no less than 20 but no more than 50. 7. Has facial Acne non-inflammatory Acne lesion count (open and closed comedones) of no less than 20 but no more than 100. 8. Has two or fewer nodulocystic lesions (defined as an inflammatory lesion greater than or equal than 5 mm in diameter). 9. Has an Evaluator Global Severity Score EGSS of moderate (=3) or severe (=4) score. 10. Subject is willing to refrain from using antimicrobial topical products (shampoo, soap, Acne preparation) as well as oral and OTC Acne products. 11. Subject must be willing to comply with the study requirements. 12. Stable medical condition. 13. Subject must be in good health and free from any clinically significant disease relevant to the study that as per the physician might interfere with the study evaluation. 14. Woman and all younger female of childbearing potential must be using a highly effective method of birth control. 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 160 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: For Stage 1 only: 1. Regular use of over-the-counter (OTC) oral drugs in the 4 weeks prior to the (first) administration of the IP. 2. Occasional use of OTC drugs (except paracetamol, maximum 1 g/day) in the 2 weeks prior the (first) administration of the IP. 3. History of blood loss or donation of blood or plasma exceeding 450 ml within the last three months before first administration of IP. 4. Positive results in any of the serology tests (Human Immunodeficiency Virus (HIV1/2) antibodies, hepatitis B surface antigen, antibodies against hepatitis C virus). 5. Use of any prescribed drugs in the 4 weeks prior to the (first) administration of the IP with the exception of hormonal contraceptive. 6. Subject with a positive drug or alcohol breath test. For Stage 1 and 2: 7. Subject with an Evaluator Global Severity Score EGSS of clear (=0), almost clear (=1), mild (=2) or very severe (=5). 8. Subject with a clinical diagnosis of Acne conglobata, mirror addict Acne, Acne fulminans, secondary Acne (Chloracne, drug induced Acne), facial keloids, and hypertrophic scars, or another dermato-logical condition, or underlying disease that requires the use of interfering topical or systemic therapy. 9. Subject exposed or planning excessive sun exposure within the study timeframe. 10. Subject with any or dermatologic disorder that could be considered a differential diagnosis of Acne e.g. Rosacea, Keratosis Pilaris, etc. 11. Excessive facial hair (e.g., beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of Acne vulgaris. 12. Use on the face within 1 month prior to Baseline of: 1) cryodestruction or chemodestruction, 2) dermabrasion, 3) photodynamic therapy, 4) Acne surgery, 5) intralesional steroids, or 6) x-ray therapy. 13. Use for less than 3 months prior to Baseline of estrogens or oral contraceptives; use of such therapy must remain constant throughout the study. 14. Use within 6 months prior to Baseline of oral retinoids (e.g. Isotretinoin) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed stage 2 only). 15. Use within 1 month prior to Baseline of: 1) spironolactone, 2) systemic steroids, 3) systemic antibiotics, 4) systemic treatment of Acne vulgaris (other than oral retinoids, which require a 6-month washout), systemic anti-inflammatory agents. 16. Use within 2 weeks prior to Baseline in the face of: 1) topical steroids, 2) topical retinoids, 3) topical Acne treatments including over-the-counter preparations but excluding cosmetic (make-up) products, 4) topical anti-inflammatory agents, 5) medicated cleansers or 6) topical antibiotics. 17. Known hypersensitivity to the IP (s) or vehicle or any of their formulation ingredients. 18. Nursing mother or pregnant woman, as verified by a positive pregnancy test, or plan to become pregnant within the study timeframe. 19. Subject with clinically significant disease relevant to this study as judged by the investigator within 3 months of the study (e.g., significant lab abnormalities, myocardial infarct, stroke, cancer, connective tissue diseases (scleroderma, systemic lupus erythematosus), systemic infection (e.g., significant systemic bacterial, viral or mycotic infection), uncontrolled diabetes, etc.) including subjects with medical conditions that might require the use of immunosuppressive medications during the trial (e.g., severe, uncontrolled asthma, rheumatoid arthritis, autoimmune diseases,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety, tolerability, efficacy and pharmacokinetics of three concentrations (0.5 %, 1.5 % and 3 %) of topical anti-Acne product Neramexane mesylate gel, quaque die (qd) when compared to vehicle in subjects with Moderate to Severe Acne.;Secondary Objective: ;Primary end point(s): • Change from Baseline to Week 12 in inflammatory Acne lesion counts.;Timepoint(s) of evaluation of this end point: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change from Baseline to Week 12 in non-inflammatory Acne lesion counts. • Dichotomized assessment of improvement of two grades (improvement versus no improvement) at Week 12 from Baseline EGSS. ;Timepoint(s) of evaluation of this end point: Week 12 | — |
Countries
Germany
Outcome results
None listed