CTRI/2018/06/014684 [Registered on: 29/06/2018] Trial Registered Prospectively
Last Modified On:
10/01/2020
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Clinical study to compare efficay of two formulations of Clindamycin Phosphate 1.2% and Benzoyl Peroxide 5% Gel in patients with Acne Vulgaris
Scientific Title of Study
A Randomized, Double blind, Multicenter, Three-arm, Parallel, Placebo-controlled, Clinical Study to Evaluate the Bioequivalence using Clinical Endpoint of Clindamycin Phosphate 1.2% and Benzoyl Peroxide 5% Gel (Encube Ethicals Private Limited, India) to DUAC® Gel (Clindamycin Phosphate 1.2% and Benzoyl Peroxide 5% Gel) (Stiefel Laboratories, Inc. Research Triangle Park, NC 27709) in Subjects with Acne Vulgaris
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
CRL011812, Version 1.0, Dated 20 Feb 18
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Ankesh Barnwal
Designation
Medical Monitor
Affiliation
Cliantha Research Limited
Address
Cliantha Research Limited,
Garden View Corporate House No.7,
Opposite AUDA Garden, Bodakdev,
Ahmedabad-380054,
Gujarat, India.
Ahmadabad GUJARAT 350054 India
Phone
07966219545
Fax
07966219549
Email
abarnwal@cliantha.in
Details of Contact Person Scientific Query
Name
Dr Ankesh Barnwal
Designation
Medical Monitor
Affiliation
Cliantha Research Limited
Address
Cliantha Research Limited,
Garden View Corporate House No.7,
Opposite AUDA Garden, Bodakdev,
Ahmedabad-380054,
Gujarat, India.
Ahmadabad GUJARAT 350054 India
Phone
07966219545
Fax
07966219549
Email
abarnwal@cliantha.in
Details of Contact Person Public Query
Name
Mr Vidhu Shekhar Mishra
Designation
Project Manager
Affiliation
Cliantha Research Limited
Address
Cliantha Research Limited,
Garden View Corporate House No.7,
Opposite AUDA Garden,
Bodakdev, Ahmedabad-380054,
Gujarat, India
Ahmadabad GUJARAT 380054 India
Phone
07966219532
Fax
07966219549
Email
vmishra@cliantha.in
Source of Monetary or Material Support
Encube Ethicals Private Limited
Primary Sponsor
Name
Encube Ethicals Private Limited
Address
Encube Ethicals Private Limited, Unit No. 24, Steelmade Industrial Estate,
Marol Village, Andheri (E),
Mumbai – 400059
Department of Dermatology , Ground floor AIMS Hospital, M.I.D.C., Milap Nagar, Dombivli (East), Dombivli-421203, Maharashtra Mumbai MAHARASHTRA
9167551456
drvaibhavkalambe@gmail.com
Dr Sharmila Patil
Dr. D.Y. Patil Medical College and Research Centre
Dept. of Dermatology, 1st floor, Dr. D.Y. Patil Medical College and Research Centre, Sector 5, Nerul, Navi Mumbai-400706, Maharashtra Mumbai MAHARASHTRA
9821350217
drsharmilapatil@gmail.com
Dr Nayan Harshadbhai Patel
GCS Medical College
Department of Dermatology Ground floor OPD No-35 GCS Medical College, Opp. D.R.M. Office, Nr. Chamunda Bridge, Naroda Road, Ahmedabad-380025, Gujarat Ahmadabad GUJARAT
9925011309
patelnayan78.na@gmail.com
Dr Khemani Usha Naraindas
Gokuldas Tejpal Hospital
Grant government Medical College, Nr. Police Commissioner Office, Lokmanya Tilak Marg, Fort, Mumbai- 400001, Maharashtra, India. Mumbai MAHARASHTRA
9821359301
ushakhemani@gmail.com
Dr Shivkumar Patil
KLES Dr. Prabhakar Kore Hospital & Medical Research Centre
KLES Dr. Prabhakar Kore Hospital & Medical Research Centre, Nehrunagar, Belagavi-590010, Karnataka, India Belgaum KARNATAKA
9844512315
shivakumarkpatil@gmail.com
Dr Sonal Mahadev Shendkar
Lifepoint Multispeciality Hospital
145/1, Mumbai Bangalore Highway, Near Hotel Sayaji, Wakad, Pune -411057, Maharashtra, India. Pune MAHARASHTRA
9960178611
Shendkar.sonal82@gmail.com
Dr Rachita Dhurat
Lokmanya Tilak Municipal General Hospital
New OPD Buliding 2nd floor OPD 16 Department of Dermatology, LokmanyaTilak Municipal General Hospital, Dr. BabasahebAmbedkar Road, Sion (West), Mumbai-400022, Maharashtra Mumbai MAHARASHTRA
9870390057
rachitadhurat@yahoo.co.in
Dr Grandhi Sudhakarrao Venkata
Medipoint Hospitals Pvt. Ltd.
OPD Building Ground floor, Medipoint Hospitals Pvt. Ltd., 241/1, New D.P. Road, Anudh, Pune-411007, Maharashtra, India Pune MAHARASHTRA
1 Uday park society , Nr. Sunrise Park, Vastrapur, Ahmedabad-380015, Gujarat, India. Ahmadabad GUJARAT
9904079691
Drruchirshah.dermatologist@gmail.com
Dr Smita Nagpal
Saviour Multispeciality Hospital
Near Bharat Petrol Pump, Near Lakhudi Talav, Stadium Road, Navrangpura, Ahmedabad-380014, Gujarat, India. Ahmadabad GUJARAT
9825721525
nagpalsmita@gmail.com
Dr Manoj Rajgopal
Shettys Hospital
Department of Dermatology, 2nd floor Shettys Hospital, Kaveri Nagar, Bommanahalli, Bengaluru-560068, Karnataka Bangalore KARNATAKA
9535072175
sumanahospitalresearch@gmail.com
Dr Bhavik Bhavsar
Shivam Hospital and Research Center
Ground floor OPD, Shivam Hospital and Research Center, Satyanarayan Society, GorsKuva, Jashodanagar Road, Maninagar, Ahmedabad, Gujarat Ahmadabad GUJARAT
9825953263
bhavik.bhavsar78@gmail.com
Dr SC Bharija
Sir Ganga Ram Hospital
Department of Dermatology, 4th Floor HR Building, Sir Ganga Ram Hospital, Rajinder Nagar, New Delhi-110060 Central DELHI
9810068687
drscbharija@gmail.com
Dr Harish Prasad BR
Sri Venkateshwara Hospital
Department of Dermatology, 3rd floor, Sri Venkateshwara Hospital, 86, Hosur Main Road, Madiwala, Bangalore -560068, Karnataka, India Bangalore KARNATAKA
9838389028
harish.harris@gmail.com
Dr Murali Narasimhan
SRM Medical College Hospital & Research Centre
Department of Dermatology, 1st floor, SRM Medical College Hospital & Research Centre, Dept. of Dermatology, Venereology and Leprosy, Potheri, Kattankulathur-603203, Tamilnadu Kancheepuram TAMIL NADU
9840168711
leecutis@gmail.com
Dr Deepak Kotkar
Supe Heart & Diabetes Hospital and Research Centre
Department of Dermatology 1st floor, Supe Heart and Diabetes Hospital, opp. Adhar ashram, Near Runtha School, Gharpuraghat, Ashok Stambh, Nashik-422002, Maharashtra Nashik MAHARASHTRA
9371580600
deepakkotkar@gmail.com
Dr Jadhav Nikita Sharad
Vijay Vallabh Hospital and medical research centre
Institutational Ethics committe for Human Resaerch LokmanyaTilak Municipal Hospital, Dr. Babasaheb Ambedkar Road, Sion West, Mumbai, Maharashtra 400022
Approved
Institutational Ethics Committee, Padmashree Dr. D.Y.Patil Medical college and Hospital and Research Centre, Sector 5, Nerul, NavI Mumbai-400706
Approved
Institutional Ethics committee ,Grant Government Medical college,Byculla,Mumbai-400008
Approved
Institutional Ethics Committee GCS Medical College Hospital & Research Centre, Near Chamunda Bridge, Naroda Road, Ahmedabad.
Approved
Institutional Ethics Committee KLE University, J N Medical College, Nehru Nagar, Belagavi - 590010
Approved
Institutional Ethics Committee SRM Medical College Hospital & Research Centre SRM Nagar, Potheri, Kattankulathur, Kancheepuram - 603203
Sir Ganga Ram Hospital Ethics Committee, Room No.1496. IV Floor, Old Building Old Rajinder nagar, NewDelhi 110060 India
Approved
Sri Venkateshwara Hospital Ethics Committee, Sri Venkateshwara Hospital, #86, Hosur Main Road, Madiwala, Bangalore, Karnataka-560068
Approved
Supe Hospital Ethics Committee Near Rungta High School, Gharapure Ghat Rd, Ashok Stambh, Panchavati, Nashik- 422002, Maharashtra
Approved
Suraksha Ethics Committee, Asian Institute of Medical Sciences (AIMS), Plot P-72, Milap Nagar, MIDC, Dombivli-421203, Dist. Thane, Maharashtra, India
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
Acne Vulgaris,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Clindamycin Gel
DUAC® Gel (clindamycin phosphate 1.2% and benzoyl peroxide 5% Gel of Stiefel Laboratories, Inc. Research Triangle Park, NC 27709
Dosage: approx 0.5 gm
Route ofadministration:Topical Once a day
Duration: application for 78 days
Intervention
Clindamycin Phosphate 1.2% /
Benzoyl Peroxide 5% Gel of Encube Ethicals Private Limited, India,
India.
Clindamycin Phosphate 1.2% /Benzoyl Peroxide 5% Gel of Encube Ethicals Private Limited, India.
Dosage: approx 0.5 gm
Route ofadministration:Topical Once a day
Duration: application for 78 days
Comparator Agent
Placebo
Placebo gel manufactured by Encube Ethicals Private Limited, India
Dosage: approx 0.5 gm
Route ofadministration:Topical Once a day
Duration: application for 78 days
Inclusion Criteria
Age From
12.00 Year(s)
Age To
40.00 Year(s)
Gender
Both
Details
Healthy male or non-pregnant female aged more than or equal to 12 and less than or equal to 40 years with a clinical diagnosis of Acne vulgaris.
On the face, more than or equal to 25 non-inflammatory lesions (i.e., open and closed comedones) AND more than or equal to 20 inflammatory lesions (i.e., papules and pustules) AND less than or equal to 2 nodules.
Investigator’s Global Assessment (IGA) of acne severity grade 2, 3 or 4 (refer Table 4).
Willing to refrain from use of all other topical acne medications or antibiotics during the 11 week treatment period.
Male subjects and Female subjects of childbearing potential agree to use accepted methods of birth control including abstinence, from study start to 7 days after the last application of study drug.
Willing to provide written informed consent or assent, as applicable. For subjects who are considered minors (less than 18 completed years), the parent or legal guardian should sign the consent form and the child will be required to sign a subject “assent†form, as appropriate.
ExclusionCriteria
Details
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).
Subjects who have acne conglobata, acne fulminans, nodulocystic acne and secondary acne (e.g.: chloracne and drug induced acne).
Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris. Well-trimmed moustaches are allowed.
History of hypersensitivity or allergy to clindamycin or lincomycin or benzoyl peroxide and/or any of the study medication ingredients.
Use within 6 months prior to baseline (Randomisation) of oral retinoids (e.g.
Accutane®) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed).
Use for less than 3 months prior to baseline (Randomisation) of estrogens or oral contraceptives; use of such therapy is allowed if it will remain constant throughout the study.
Use on the face within 1 month prior to baseline (Randomisation) of: 1) cryodestruction or chemodestruction, 2) dermabrasion / microdermabrasion, 3) photodynamic therapy, 4) acne surgery, 5) intralesional steroids, 6) X-ray therapy, or 7) chemical or laser peel.
Use within 1 month prior to baseline (Randomisation) 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.
Use within 2 weeks prior to baseline (Randomisation) of: 1) topical steroids, 2) topical retinoids, 3) topical acne treatments including over-the-counter preparations, 4) topical anti-inflammatory agents, 5) medicated cleansers/shampoo or 6) topical antibiotics.
Subjects who have received neuromuscular blocking agents within 14 days prior to study entry (Randomisation).
Used astringents and alcoholic toners for less than 2 weeks prior to the start of the study. The subject must have had an established regimen for at least 2 weeks prior to enrolment and must not have anticipated changing their regimen during the conduct of the entire study.
Used abradants, facials, peels containing glycolic or other acids, masks; washes or soaps containing benzoyl peroxide, salicylic acid, or sulfacetamide sodium; non-mild facial cleansers; moisturizers that contained retinol, salicylic acid or alpha or beta hydroxy acids within the previous 2 weeks.
Concomitant use/planned to use of mega-doses of certain vitamins (such as mega-doses of vitamin D [more than 2000 IU/day], vitamin B6 [more than 2 mg] or vitamin B12 [more than 1 mg/day]), haloperidol, halogens such as iodide and bromide, lithium, hydantoin and phenobarbital.
Use of tanning booths or tanning lamps within 1 week prior to Baseline and an unwillingness to refrain from use during the study.
A significant medical history of or are currently immunocompromised or receiving immunomodulators/biologics since last 3 months.
Subjects with clinically significant vital sign abnormality.
Have a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.
Subjects with clinically significant unstable medical disorders, life-threatening disease, or current malignancies.
Subjects who engage in activities that involve excessive or prolonged exposure to sunlight.
History of drug or alcohol abuse within last 6 months.
Lived in the same household as currently enrolled subjects.
Female subjects who are breast-feeding or planning to become pregnant.
Subjects who have been treated with an investigational drug or investigational device within a period of 30 days prior to study enrolment.
Clinically significant abnormal findings or condition (other than acne), which might, in the opinion of the Investigator, interfere with study evaluations orpose a risk to subject safety during the study
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
Mean percent change from baseline to week 11 (study Day 77) for inflammatory (papules and pustules) lesions count.
Day 0 and Day 77
Secondary Outcome
Outcome
TimePoints
Mean percent change from baseline to week 11 in the non-inflammatory lesion count.
Proportion of subjects with a clinical response of “success†at week 11
Day 0 and Day 77
Target Sample Size
Total Sample Size="910" Sample Size from India="910" Final Enrollment numbers achieved (Total)= "910" Final Enrollment numbers achieved (India)="0"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
A Randomized, Double blind, Multicenter, Three-arm, Parallel, Placebo-controlled, Clinical Study to Evaluate the Bioequivalence using Clinical Endpoint of Clindamycin Phosphate 1.2% and Benzoyl Peroxide 5% Gel (Encube Ethicals Private Limited, India) to DUAC® Gel (Clindamycin Phosphate 1.2% and Benzoyl Peroxide 5% Gel) (Stiefel Laboratories, Inc. Research Triangle Park, NC 27709) in Subjects with Acne Vulgaris that will be conducted in twenty centers in India. The primary outcome measures will be mean percent change from baseline to week 11 (study Day 77) for inflammatory (papules and pustules) lesions count. The secondary outcome measures will be mean percent change from baseline to week 11 in the non-inflammatory lesion count and proportion of subjects with a clinical response of “success†at week 11.