Health Condition 1: null- Acne Vulgaris
Conditions
Interventions
Intervention1: Clindamycin 1% and Benzoyl Peroxide 5% gel: Clindamycin 1% and Benzoyl Peroxide 5% gel is manufactured by Watson Pharma Pvt Ltd. 230 patients out of 690 will receive intervention drug.
Sponsors
Watson Pharma Pvt Ltd India
Eligibility
Inclusion criteria
Inclusion criteria: Healthy male or non-pregnant female aged >= 18 and 2. On the face, >=25 non-inflammatory lesions (i.e., open and closed comedones) and >= 20 inflammatory lesions (i.e., papules and pustules) and 3. Subjects must have Investigatorâ??s Global Assessment (IGA) of acne severity grade 2, 3, or 4. 4. Willing to refrain from use of all other topical acne medications or antibiotics during the 10 week treatment period. 5. Subjects must have provided IEC/IRB approved written informed consent. 6. Subjects may have acne lesions on other areas of the body (e.g., on the back). 7. Female subjects of childbearing potential must use accepted methods of birth control or must agree to continue to practice abstinence, from 30 days prior to study entry to 30 days after the last administration of study drug. All female subjects are considered to be of childbearing potential unless they have been surgically sterilized or have been postmenopausal for at least 1 year. Abstinence is an acceptable method of birth control. Any of the following methods of birth control are acceptable: oral contraceptives, contraceptive patches/implants (e.g., Norplant®) Depo-Provera®, double barrier methods (e.g., condom and spermicide) or IUD. Female subjects must have a negative serum pregnancy test at baseline. 8. All male subjects must agree to use accepted methods of birth control with their partners, from the day of the first dose administration to 30 days after the last administration of study drug. Abstinence is an acceptable method of birth control. Any of the following methods of birth control are acceptable: oral contraceptives, contraceptive patches/implants (e.g., Norplant®), Depo-Provera®, double barrier methods (e.g., condom and spermicide) or IUD. 9. Subjects must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits. 10. Subjects must be willing to refrain from using any other treatments for acne vulgaris, including antibiotics, other than the investigational product, for acne present on the face. Subjects may use other topical acne treatments that do not have significant or measurable systemic absorption for treatment of acne of the back, shoulders and chest (e.g. benzoyl peroxide, salicylic acid). 11. Subjects must be in good health and free from any clinically significant disease at the discretion of the Investigator. 12. Subjects having normal 12-lead electrocardiogram (ECG) as certified by physician. 13. Subjects having normal chest X-Ray (Postero Anterior view) 14. Subjects who use make-up must have used the same brands/types of make-up for a minimum period of 14 days prior to study entry and must agree to not change make-up brand/type or frequency of use throughout the study.
Exclusion criteria
Exclusion criteria: 1. History of hypersensitivity or allergy to clindamycin or benzoyl peroxide or clindamycin and/or any of the study medication ingredients. 2. Presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis). 3. Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris 4. Use within 6 months prior to baseline of oral retinoids (e.g. Accutane®) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed). 5. Use for less than 3 months prior to baseline of estrogens or oral contraceptives; use of such therapy must remain constant throughout the study 6. Use on the face within 1 month prior to baseline or during the study of: 1) cryodestruction or chemodestruction, 2) dermabrasion, 3) photodynamic therapy, 4) acne surgery, 5) intralesional steroids, or 6) x-ray therapy. 7. Use within 1 month prior to baseline of: 1) spironolactone, 2) systemic steroids, 3) systemic antibiotics, 4) systemic treatment for acne vulgaris (other than oral retinoids, which require a 6-month washout), or 5) systemic anti-inflammatory agents. 8. Use within 2 weeks prior to baseline of: 1) topical steroids, 2) topical retinoids, 3) topical acne treatments including over-the-counter preparations, 4) topical anti-inflammatory agents, 5) medicated cleansers or 6) topical antibiotics. 9. Subjects who have acne congoblata, acne fulminans, and secondary acne (e.g., chloracne and drug induced acne) will be excluded from participation. 10. Female subjects who are pregnant, nursing or planning to become pregnant during study participation (Visit 1 through Visit 4 and 30 days post visit 4) will be excluded from study participation. 11. Subjects who have received radiation therapy and/or anti-neoplastic agents within90 days prior to baseline will be excluded from study participation. 12. Subjects who have unstable medical disorders that are clinically significant or life-threatening diseases will be excluded from study participation. 13. Subjects who have on-going malignancies requiring systemic treatment will be excluded from study participation. In addition, subjects who have any malignancy of the skin of the facial area will be excluded from study participation. 14. Subjects who engage in activities that involve excessive or prolonged exposure to sunlight or weather extremes, such as wind or cold, will be excluded from study participation. 15. Subjects who have facial sunburn will be excluded from study participation 16. Subjects who consume excessive amounts of alcohol (greater than two drinks per day) or use drugs of abuse (including, but not limited to, cannabinoids and cocaine) as judged by their medical history will be excluded from study participation. 17. History or presence of significant smoking (more than 10 cigarettes or bidis/day or consumption of tobacco products). 18. Systolic blood pressure less than 90 mm Hg or more than 140 mm Hg, Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg and Pulse rate less than 50 beats/minute or more than 100 beats/minute 19. Subjects who have participated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EVALUATION OF SAFETY/EFFICACY 1. Mean% change from baseline to week 10 in the inflammatory (papules and pustules) lesion count 2. Mean% change from baseline to week 10 in the non-inflammatory (open and closed comedones) lesion count 3. The primary BE comparison is between the T and R for the mean% change from baseline in the inflammatory & non-inflammatory lesion counts using the PP study population 4. Incidence of all AEs reported during study will be summarized using the MedDRA dictionaryTimepoint: Visit 1: Baseline Visit (Day 1) Visit 2: First Interim Visit (Day 28 ± 4 Days) Visit 3: Second Interim Visit (Day 56 ± 4 Days) Visit 4: End of Treatment Visit (Day 70 ± 4 Days) | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary efficacy evaluation is based on the secondary efficacy measure, i.e. the proportion of â??successâ?? subjects at week 10, measured using the IGA severity score (see section 6.2) where â??successâ?? is defined as an IGA score that is at least 2 grades less than the baseline assessment and â??failureâ?? is defined as an IGA score that is the same, higher or one grade lower than the baseline assessment.Timepoint: Visit 1: Baseline Visit (Day 1) Visit 2: First Interim Visit (Day 28 ± 4 Days) Visit 3: Second Interim Visit (Day 56 ± 4 Days) Visit 4: End of Treatment Visit (Day 70 ± 4 Days) | — |
Countries
India
Contacts
Public ContactDr Sumit Arora
Lotus Labs Pvt Ltd
Outcome results
None listed