A clinical study to evaluate the efficacy and safety of Ozenoxacin Lotion in patients with pimples.
- Conditions
- Health Condition 1: L700- Acne vulgaris
- Registration Number
- CTRI/2021/09/036780
- Lead Sponsor
- Precise Biopharma P Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 253
1. Male or female patients aged between 18 to 65 years (both inclusive) with a clinical diagnosis of acne vulgaris with facial involvement.
2. Patient must have a score of 2 (mild) or 3 (moderate) on the Investigatorââ?¬•s Global Assessment (IGA) at the screening / baseline visit.
3. Patients with facial acne inflammatory lesion (papules and pustules) count of at least 20.
4. Patients with facial acne non-inflammatory lesion (open and closed comedones) count of at least 25.
5. Patients with two or fewer facial nodulocystic lesions.
6. 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 / baseline visit.
7. 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. Subjects should continue to use these investigator-approved products for the duration of the study and should avoid any changes in these consumer products.
8. Patient with ability to understand and provide written informed consent form, which must have been obtained prior to screening.
9. Patients willing to comply with the protocol requirements throughout the study.
1. Patients with known or suspected hypersensitivity to quinolone antibacterial agents.
2. 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).
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. Treatment with the following products:
a) Topical acne treatments (retinoids, antibiotics, Benzoyl Peroxide, Azelaic Acid, Resorcinol, salicylates, �±-hydroxy/glycolic acid), or other topical facial medication (antifungals, steroids, anti-inflammatories) on the treatment area in the 14 days prior to the baseline visit, including prescription and non-prescription products.
b) Systemic corticosteroids, systemic acne treatments including systemic antibiotics used for treatment of acne, potential photosensitizing agents (thiazides, phenothiazines), Spironolactone, Flutamide, or immunosuppressant drugs in the 30 days prior to the baseline visit.
c) Systemic retinoid use (including high dose vitamin A > 10,000 units per day) in the 180 days prior to the baseline visit.
d) Undertaken certain facial procedures such as chemical peel, laser treatment, photodynamic therapy, acne surgery, cryodestruction or chemodestruction, x-ray therapy, intralesional steroids, dermabrasion, or depilation (except eyebrow shaping) in the 30 days prior to the baseline visit. After the subject is enrolled in the study, eyebrow shaping (except for tweezing) is prohibited.
e) Treatment with a medication or procedure that, in the opinion of the investigator, would put the subject at unacceptable risk for participation in the study or may interfere with evaluations in the study.
5. Patients with Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 [using the Modification of Diet in Renal Disease (MDRD) equation] at screening.
6. Patients with clinically significant impaired hepatic function (SGOT & SGPT more than 3X the UNL and/or Total bilirubin more than 1.5X the UNL) at screening.
7. Patients with uncontrolled hypertension with sitting systolic BP � 160 mmHg and/or diastolic BP � 100 mmHg at screening.
8. Females who are pregnant or lactating or planning to become pregnant during the study period.
9. Female patients who are of childbearing potential and who are neither surgically sterilized nor willing to use reliable contraceptive methods (like hormonal, barrier methods or intrauterine device).
10. Any abnormality on 12-lead ECG at screening that in the opinion of the investigator is clinically significant and is judged as potential risk for patientââ?¬•s participation in the study.
11. Subject 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.
12. Patients who have used estrogens or oral contraceptives within 4 weeks prior to randomization.
13. Patients with a serious and/or chronic medical condition such as chronic or active liver disease, renal impairment, heart disease, severe respiratory disease, rheumatoid a
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients in each treatment group achieving ââ?¬Å?successââ?¬? at Week 12.Timepoint: At Visit 6 [Week 12 / Day 84 (Ã?±2)].
- Secondary Outcome Measures
Name Time Method Adverse events / serious adverse events <br/ ><br>reported during the study.Timepoint: Throughout the study.;Change from baseline to week 12 in inflammatory lesion (papules and pustules) count.Timepoint: At Screening/baseline visit, <br/ ><br>Visit 3 [Week 2 / Day 14 (�±2)], <br/ ><br>Visit 4 [Week 4 / Day 28 (�±2)], <br/ ><br>Visit 5 [Week 8 / Day 56 (�±2)] and <br/ ><br>Visit 6 [Week 12 / Day 84 (�±2)].;Change from baseline to week 12 in non-inflammatory lesion (open and closed comedones) count.Timepoint: At Screening/baseline visit, <br/ ><br>Visit 3 [Week 2 / Day 14 (�±2)], <br/ ><br>Visit 4 [Week 4 / Day 28 (�±2)], <br/ ><br>Visit 5 [Week 8 / Day 56 (�±2)] and <br/ ><br>Visit 6 [Week 12 / Day 84 (�±2)].;Changes in clinical laboratory parameters from baseline to end of the study visit (week 12).Timepoint: At Screening/baseline visit and <br/ ><br>Visit 6 [Week 12 / Day 84 (�±2)].