Health Condition 1: L700- Acne vulgaris
Conditions
Interventions
Intervention1: FDC of Clindamycin Phosphate IP 1.2 percentage w/w plus Benzoyl Peroxide IP 3.75 percentage w/w Topical Gel: Apply a pea sized amount of topical gel to the face once daily for 12 weeks.
Sponsors
Precise Biopharma Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female patients aged between 12 to 65 years (both inclusive) with a clinical diagnosis of acne vulgaris at screening or baseline visit. 2. Patients with an Investigator s Global Assessment (IGA) score of 2 (mild) or 3 (moderate) at screening or baseline visit. 3. Patient has facial acne vulgaris, with at least 20 to a maximum of 40 inflammatory lesions (papules and pustules) and 20 to a maximum of 100 non-inflammatory lesions (open and closed comedones). 4. Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study. WOCBP must have a negative urine pregnancy test at screening or baseline visit. 5. Patients agree not to use any product on the face during the entire course of study except for non-medicated, investigator-approved cleanser, sunscreen, face wash and make-up. Patients should continue to use these investigator-approved products for the duration of the study and should avoid any changes in these consumer products. 6. Patient with ability to understand and provide written, signed and dated informed consent form (for patients aged between greater than or equal to 18 to smaller than or equal to 65 years) or assent form (for patients aged between greater than or equal to 12 to smaller than 18 years), which must have been obtained prior to screening. 7. Patients willing to comply with all the protocol requirements throughout the study.
Exclusion criteria
Exclusion criteria: 1. Patients with the 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, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis). 2. Patients who have acne conglobata, acne fulminans, nodulocystic acne and secondary acne (e.g., chloracne and drug induced acne). 3. Patients with excessive facial hair (e.g., heavy beards or moustaches), facial tattoos or facial disfigurement that would interfere with diagnosis or assessment of acne vulgaris. 4. Patient has greater than two (2) facial nodules. 5. Patients with uncontrolled hypertension with sitting systolic BP more than or equal to 160 mmHg and or diastolic BP more than or equal to 100 mmHg at screening. 6. Patients with clinically significant impaired hepatic function (SGOT and SGPT more than 3X the UNL) and or renal dysfunction (serum creatinine more than or equal to 2.5 mg by dL) at screening or baseline visit. 7. Patient has a history of experiencing significant burning or stinging when applying any facial treatment (e.g., make-up, soap, masks, washes, sunscreens, etc.) to their face. 8. Patients who have used estrogens or oral contraceptives within 4 weeks prior to screening visit. 9. Patients with a serious and/or chronic medical condition such as chronic or active liver disease, renal impairment, heart disease, severe respiratory disease, rheumatoid arthritis, current malignancies, immunocompromised conditions, or any other disease that, in the opinion of the investigator, would interfere with the study or place the subject at unacceptable risk. 10. Patients with a history of substance abuse or dependence that in the opinion of the Investigator is considered to interfere with the patient s participation in the study. 11. Patients with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent or assent. 12. Patients currently taking any of the prohibited medications(s) and inability or unwillingness to discontinue them for the entire study period. 13. Patients with suspected inability or unwillingness to comply with the study procedures. 14. Patient with any condition which, in the judgment of the Investigator, may render the patient unable to complete the study or which may pose a significant risk to the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients reporting incidences of AE and / or SAE during the study and their assessment in respect to intensity, duration, pattern and causal relationship to the study medication.Timepoint: At Visit 2 - Enrolment visit (Day 1), Visit 3 - Follow up visit / Week 4 (Day 28 4), Visit 4 - Follow up visit / Week 8 (Day 56 4) and Visit 5 - End of the study visit / Week 12 (Day 84 4). | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving success at Week 12 ( success defined as IGA score of clear (score=0) or almost clear (score=1) and/or at least a two-point reduction in IGA score compared to baseline).Timepoint: At Visit 5 - End of the study visit / Week 12 (Day 84 4);Mean change from baseline to week 12 in inflammatory lesion (papules and pustules) count.Timepoint: At Visit 1 - Screening or Baseline visit (Day -7) and Visit 5 - End of the study visit / Week 12 (Day 84 4). ;Mean change from baseline to week 12 in non-inflammatory lesion (open and closed comedones) count.Timepoint: At Visit 1 - Screening or Baseline visit (Day -7) and Visit 5 - End of the study visit / Week 12 (Day 84 4).;Percent change from baseline to week 12 in inflammatory lesion (papules and pustules) count.Timepoint: At Visit 1 - Screening or Baseline visit (Day -7) and Visit 5 - End of the study visit / Week 12 (Day 84 4).;Percent change from baseline to week 12 in non-inflammatory lesion (open and closed comedones) count.Timepoint: At Visit 1 - Screening or Baseline visit (Day -7) and Visit 5 - End of the study visit / Week 12 (Day 84 4).;Local tolerability (application site reactions) during the study.Timepoint: At Visit 2 - Enrolment visit (Day 1), Visit 3 - Follow up visit / Week 4 (Day 28 4), Visit 4 - Follow up visit / Week 8 (Day 56 4) and Visit 5 - End of the study visit / Week 12 (Day 84 4).;Changes in clinical laboratory parameters from baseline to end of the study visit (week 12).Timepoint: At Visit 1 - Screening or Baseline visit (Day -7) and Visit 5 - End of the study visit / Week 12 (Day 84 4). | — |
Countries
India
Contacts
Public ContactMr Vipen Seth
Clinwave Research Pvt. Ltd.
Outcome results
None listed