CTRI/2021/09/036780 [Registered on: 23/09/2021] Trial Registered Prospectively
Last Modified On:
10/08/2022
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Multiple Arm Trial
Public Title of Study
A clinical study to evaluate the efficacy and safety of Ozenoxacin Lotion in patients with pimples.
Scientific Title of Study
“A Multicentric, Randomized, Prospective, Double Blind, Parallel Group, Comparative and Phase III Clinical Study to Evaluate the Efficacy and Safety of Ozenoxacin Lotion 2% w/v in the Treatment of Patients with Acne Vulgaris.â€
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
PB/OZE/CT/21/001
Protocol Number
Version No. 01 & Dated Jul 12, 2021
Other
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr V Revathi
Designation
Tutor
Affiliation
Government Medical College & Government General Hospital (Old RIMSGGH)
Address
Department of Dermatology,
Government Medical College & Government General Hospital (Old RIMSGGH), Srikakulam-532001.
Srikakulam ANDHRA PRADESH 532001 India
Phone
8942279033
Fax
Email
drrevathiggh@gmail.com
Details of Contact Person Scientific Query
Name
Dr Rajasekhara Reddy Tamma
Designation
Managing Director
Affiliation
Clinwave Research Pvt. Ltd.
Address
Clinwave Research Pvt. Ltd.,
# H. No.: 4-32-41/13, Plot No.: 38,
Kamala Prasanna Nagar,
Near Ramalayam Temple,
Kukatpally, Hyderabad-500072.
Hyderabad TELANGANA 500072 India
Phone
7989233379
Fax
Email
dr.sekhar@clinwave.co.in
Details of Contact Person Public Query
Name
Mr Vipen Seth
Designation
President - Drug Regulatory Affairs
Affiliation
Precise Biopharma P. Limited
Address
Precise Biopharma P. Limited,
209, Jhalawar,
E. S. Patanwala Industrial Estate,
L.B.S. Marg, Ghatkopar (W),
Mumbai-400086.
Mumbai (Suburban) MAHARASHTRA 400086 India
Phone
8860833301
Fax
Email
vipen@precisegroup.co.in
Source of Monetary or Material Support
Precise Biopharma P. Limited,
209, Jhalawar,
E. S. Patanwala Industrial Estate,
L.B.S. Marg, Ghatkopar (W),
Mumbai-400086, Maharashtra, India.
Primary Sponsor
Name
Precise Biopharma P Limited
Address
209, Jhalawar,
E. S. Patanwala Industrial Estate,
L.B.S. Marg, Ghatkopar (W),
Mumbai-400086, Maharashtra, India.
North East Healthcare Private Limited, W Pratiksha Hospital
Approved
Rajarshee Chhatrapati Shahu Maharaj Govt. Medical College and Chhatrapati Pramila Raje General Hospital, Kolhapur Institutional Ethics Committee 2 (RCSMGMCIEC2)
Approved
Sangini Hospital Ethics Committee, Hope Well Medical Hospital
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: L700||Acne vulgaris,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Benzoyl Peroxide Gel 2.5% w/w
Patients will be advised to apply an appropriate amount of study medication once a day to the affected area around same time every day for 12 weeks.
Intervention
Ozenoxacin Lotion 2% w/v
Patients will be advised to apply an appropriate amount of study medication once a day to the affected area around same time every day for 12 weeks.
Comparator Agent
Placebo Lotion
Patients will be advised to apply an appropriate amount of study medication once a day to the affected area around same time every day for 12 weeks.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
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 Investigator’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.
ExclusionCriteria
Details
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, α-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 patient’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 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.
14. 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.
15. Patients with concurrent participation in another clinical trial or any investigational therapy within 90 days prior to signing informed consent.
16. Patients currently taking any of the prohibited medications(s) and inability/unwillingness to discontinue them for the entire study period.
17. Suspected inability or unwillingness to comply with the study procedures.
18. 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.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Sequentially numbered, sealed, opaque envelopes
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
Proportion of patients in each treatment group achieving “success†at Week 12.
At Visit 6 [Week 12 / Day 84 (±2)].
Secondary Outcome
Outcome
TimePoints
Change from baseline to week 12 in inflammatory lesion (papules and pustules) count.
At Screening/baseline visit,
Visit 3 [Week 2 / Day 14 (±2)],
Visit 4 [Week 4 / Day 28 (±2)],
Visit 5 [Week 8 / Day 56 (±2)] and
Visit 6 [Week 12 / Day 84 (±2)].
Change from baseline to week 12 in non-inflammatory lesion (open and closed comedones) count.
At Screening/baseline visit,
Visit 3 [Week 2 / Day 14 (±2)],
Visit 4 [Week 4 / Day 28 (±2)],
Visit 5 [Week 8 / Day 56 (±2)] and
Visit 6 [Week 12 / Day 84 (±2)].
Adverse events / serious adverse events
reported during the study.
Throughout the study.
Changes in clinical laboratory parameters from baseline to end of the study visit (week 12).
At Screening/baseline visit and
Visit 6 [Week 12 / Day 84 (±2)].
Target Sample Size
Total Sample Size="230" Sample Size from India="230" Final Enrollment numbers achieved (Total)= "253" Final Enrollment numbers achieved (India)="253"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This
trial is a multicentric, randomized, prospective, double blind, parallel group,
comparative and phase III clinical study to evaluate the efficacy and safety of
Ozenoxacin Lotion 2% w/v in the treatment of patients with acne vulgaris.
Patients
who are willing and able to participate in the study will sign and date the
Informed Consent Form on the day of screening / baseline visit (Visit 1).
During this screening period, patients who are willing to give consent will be
evaluated for all the eligibility criteria. Eligible patients (male or female) aged
between 18 to 65 years (both inclusive), who have a score of 2 (mild) or 3 (moderate) on the Investigator’s
Global Assessment (IGA) at the screening / baseline visit, facial acne inflammatory
lesion (papules and pustules) count of at least 20, facial acne
non-inflammatory lesion (open and closed comedones) count of at least 25 and
two or fewer facial nodulocystic lesions will be considered for the
study.
After confirming the inclusion/exclusion criteria the
subject will be randomized and provided with study medication at randomization
visit. Subjects will be provided with patient diary at randomization visit,
which need to be brought along with in each subsequent visit till the last
visit. Follow up visits will be done on week 2/day 14(±2), week 4/day 28(±2), week
8/day 56(±2) and week 12/day 84(±2) (Final Visit) of treatment to assess efficacy
and safety.
Patients
will be assigned to either of the three arms i.e., Arm A or Arm B or Arm C consisting
of Ozenoxacin Lotion 2% w/v or Benzoyl Peroxide Gel 2.5% w/w or Placebo Lotion.
Patients will be advised to apply an appropriate amount of study medication
once a day to the affected area around same time every day for 12 weeks.