Mild to moderate acne vulgaris
Conditions
Interventions
Product Name: Rambazole
Product Code: R115866
Pharmaceutical Form: Gel
INN or Proposed INN: NA
CAS Number: 2014-66-4
Current Sponsor code: R115866
Other descriptive name: Rambazole
Concentration unit:
Sponsors
Barrier Therapeutics nv
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A subject meeting all the following inclusion criteria is eligible for inclusion in the trial: 1. Subjects with a history of facial acne vulgaris of at least 6 months, the presence of mild to moderate facial acne vulgaris having at least 50 non-inflammatory lesions, at least 15 inflammatory lesions with no nodulocystic lesions and with a total number of lesions between 65 and 200 2. Global Acne Score at Visit 1 must be =2 (grading score 0 – 5) 3. Clinical laboratory Visit 1 test results (biochemistry and hematology, and urine analysis) within the laboratory reference range or considered as not clinically relevant by the investigator 4. Men and women (age 18 to 50) 5. Body Mass Index between 18 and 28 6. Written informed consent to participate in the trial, prior to beginning protocol-specific procedures, indicating an understanding of the purpose of this trial and a willingness to adhere to the treatment regimen and trial procedures described in this protocol 7. Willingness to continue the usual habits of own cleansing and cosmetic products (e.g. soaps, creams, moisturizers) in the treatment area throughout the course of the trial 8. If the subject is a female of childbearing potential, she must have a negative urine pregnancy test, and agree to use a highly effective method of contraception during the clinical trial and until the first menses after a 30 days period following the last dose of trial medication. She must be on a stable regimen, for at least three months, of oral contraceptives, contraceptive implant or depot injection or contraceptive patch and willing to continue this contraception combined with an additional local contraception method (IUD, diaphragm or condom and spermicidal agent or sterilization of the partner) starting at screening visit until the first menses after a 30 days period following the last administration of trial medication. 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects meeting one of the following exclusion criteria in not eligible for inclusion in the trial: 1. Subjects with types of acne other than acne vulgaris or with severe acne requiring oral treatment. Subjects with moderate to severe acne on the trunk 2. Pregnancy or lactation 3. Physical condition (e.g. beard) which, in the investigator's opinion, might impair evaluation of acne 4. Significant coexisting hepatic, renal, or bone marrow disease, hyperlipidemia, chronic pancreatitis, osteoporosis, or a history indicating adrenal cortex dysfunction or any other serious disease (including cancer and subjects known to be HIV or Hepatitis B/Hepatitis C positive) 5. History of heart-failure, myocardial infarction within the past six months, cardiac arrhythmia, or under treatment for heart disorders 6. History of any malignancy in the past 5 years, except for adequately treated basal cell carcinoma of the skin 7. Clinically significant ECG-intervals or morphology of the ECG; QT, or QTc >470 ms in females or >450 ms in males 8. Subject has used any of the following: oral tretinoin/isotretinoin within the last 12 months before baseline, any other oral anti-acne medication or any oral antibiotics within the last 28 days before baseline; over-the-counter topical acne preparations in the face within the last 14 days before baseline. Topical treatment with 5 % benzoylperoxide within at least 4 weeks 9. Topical therapy of the face in the last two weeks that may interfere with the aim of the trial, e.g. corticosteroids 10. Any systemic treatment or the intake of drugs interfering with the immune system (e.g. antiphlogistics, corticosteroids, immunosuppressants) within 28 days before start of the trial. This does not include minor pain relief medicine, like aspirin or acetaminophene if not more than 500 mg per day are used. 11. Use of vitamin A (>1000 µg/day), phenytoin, carbamazepine, warfarin, rifampicin, tetracyclines, ketoconazole, itraconazole, astemizole, terfenadine, cisapride, anti-psychotic, anti-depressants, lithium, cyclosporine A 12. Use of ultraviolet light (including artificial UVA and UVB as well as excessive natural sun exposure) unless stopped at Visit 1 Subjects with a history of or active alcohol or substance abuse problems 13. Known hypersensitivity to ingredients of the trial medication (R115866, carbomer, ethanol, polyethylene glycol) 14. Participation in a clinical trial within the last 30 days prior to the start of this trial 15. Subjects underlying any other restrictions due to the participation in other tests / test institutes 16. Employees of the trial site or of the Sponsor company 17. If in the opinion of the investigator the subject should not participate in the trial for any reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is the investigation of the effect on the total facial acne lesion count in subjects treated with topical R115866 gel compared to the vehicle-treated group.;Secondary Objective: The secondary objective of this study is to investigate the effects of topical R115866 gel compared to vehicle on • Global acne score • Global evaluation of effectiveness • Total, inflammatory and non-inflammatory lesion count • Safety, tolerability and local tolerance;Primary end point(s): The difference in the total lesion count after 12 weeks of treatment compared to the lesion count at baseline in the R115866-treated group and the vehicle-treated group | — |
Countries
Germany
Outcome results
None listed