Study to Evaluate the Bioequivalence using Clinical Endpoint of Tretinoin Gel Microsphere, 0.06% (Encube Ethicals Private Limited, India)in Subjects with Acne Vulgaris.
Scientific Title of Study
A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Three-arm, Parallel Study to Evaluate the Bioequivalence using Clinical Endpoint of Tretinoin Gel Microsphere, 0.06% (Encube Ethicals Private Limi ted, India) to Retin-A Micro® (Tretinoin) Gel Microsphere, 0.06% (Valeant Pharmaceuticals North America LLC, NJ 08807, USA) in Subjects with Acne Vulgaris.
Trial Acronym
G7SYN/P-001/2022
Secondary IDs if Any
Secondary ID
Identifier
G7SYN/P-001/2022, Version No-01, Dated 06-04-2022
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Ajay Alexander
Designation
Head-Clinical Trial
Affiliation
G7 Synergon Private Limited
Address
No 537 9th Cross 5th main Tata Nagar Sahakaranagar Post Bangalore Karnataka India
Bangalore KARNATAKA 560092 India
Phone
9916252529
Fax
Email
ajay.alexander@g7synergon.in
Details of Contact Person Scientific Query
Name
Dr D Sathish Kumar
Designation
Managing Director
Affiliation
G7 Synergon Private Limited
Address
No 537 9th Cross 5th main Tata Nagar Sahakaranagar Post Bangalore Karnataka India
Bangalore KARNATAKA 560092 India
Phone
9677014651
Fax
Email
sathishkumar@g7synergon.in
Details of Contact Person Public Query
Name
Dr D Sathish Kumar
Designation
Managing Director
Affiliation
G7 Synergon Private Limited
Address
No 537 9th Cross 5th main Tata Nagar Sahakaranagar Post Bangalore Karnataka India
Bangalore KARNATAKA 560092 India
Phone
9677014651
Fax
Email
sathishkumar@g7synergon.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 – 400 059,
Maharashtra, India
2nd & 3rd Floor, Research Department, 7- Orange Hospital, Pawana Nagar, Next to Jain, School, Near Chapekar Chowk, Chinchwad, Pune-411033, Maharashtra, India Pune MAHARASHTRA
8983377103
drdjogaikar@gmail.com
Dr Bhushan Sevakram Madke
Acharya Vinoba Bhave rural hospital
Ground floor, Clinical research department, Acharya Vinoba Bhave rural hospital, Sawangi (Meghe), Wardha-442004, Maharashtra, India Wardha MAHARASHTRA
9340885393
drbhushan81@gmail.com
Dr Vipul Gupta
Atharva Hospital
Basement, Clinical Research Department, Atharva Multispeciality Hospital and Research Centre, H-4, Comm-2, Construction Div - 21, UP Avas Vikas Parishad, Sector - E, Lucknow - 226002, UP, India Lucknow UTTAR PRADESH
9005044010
dr.vipulgupta24@gmail.com
Dr Renuka Ashtekar
Bharati Vidyapeeth (Deemed to be University) Medical College and Hospital
Ground floor, Clinical research department, Bharati Vidyapeeth (Deemed to be University) Medical College and Hospital Sangli, Sangli - Miraj Rd, Wanlesswadi, Sangli - 416416, Maharashtra, India Sangli MAHARASHTRA
9921653812
renukaashtekar75@gmail.com
Dr Nisha Parikh
CIMET’S Inamdar Multispeciality Hospital
Basement, Clinical Research Department, CIMET’S Inamdar multispeciality hospital, S No 15, Fatimanagar, Wanawadi, Pune-411040, Maharashtra, India Pune MAHARASHTRA
9673834553
drnishaparikh.research@gmail.com
Dr Nikam Vivek Vilas
Dr Vasant Rao Pawar Medical college and Hospital
Room no. I-239, I-240, First floor, Clinical trial unit, Dr. Vasantrao Pawar Medical College, Hospital & Research Centre, Vasantdada Nagar, Adgaon, Nashik- 422003, Maharashtra, India Nashik MAHARASHTRA
9638888527
viveknikam555@gmail.com
Dr Sakshi Midha
Excelcare Hospital
Room No.301, Research department, third floor, Excelcare Hospital, 103, Sanjay Nagar A, Joshi Marg, Kalwar Road, Jaipur- 302012, Rajasthan, India Jaipur RAJASTHAN
9001711113 9828039960 sakshi.midha@gmail.com
Dr Vishal Laxmanrao Gore Patil
Global Hospital
Ground Floor, Research Department, Global Hospital & Research Institute, Off Sinhgad Road, Near Dattawadi Police, Chowki, Dattawadi, Pune - 411030, Maharashtra, India Pune MAHARASHTRA
9657746968
drvishalgore999@gmail.com
Dr Bangaru H
K R Hospital attached to Mysore medical college and research institute
First Floor, Department of Dermatology, K R Hospital attached to Mysore medical college and research institute, Irwin road, Mysuru-570001, Karnataka, India Mysore KARNATAKA
9886789231
drbangaruskin@gmail.com
Dr Patnala Guru Prasad
King George Hospital
First Floor, Clinical research area, department of dermatology, King George Hospital Maharanipeta, Visakpatanam-530002, Andhra Pradesh, India Visakhapatnam ANDHRA PRADESH
9848022615
drpguruprasadresearch@gmail.com
Dr Shivakumar Patil
KLE’s Dr Prabhakar Kore hospital and Medical research Centre
Second Floor, Site Management office, KLE’s Dr Prabhakar Kore hospital and Medical research Centre, Nehru nagar, Belagavi-590010, Belgaum KARNATAKA
9844512315
shivakumarkpatil@gmail.com
Dr Sonal Mahadev Shendkar
Lifepoint Multispecialty Hospital
3rd Floor, Lifepoint Multispecialty Hospital, 145/1,
Mumbai Bangalore highway, Near hotel Sayaji, Wakad, Pune – 411057, Maharashtra India
Pune MAHARASHTRA
9960178611
shendkar.sonal82@gmail.com
Dr Grandhi Sudhakarrao Venkata
Medipoint Hospitals Private Limited
Third floor, research department, clinic building, Medipoint hospitals Private limited, 241/1, New D. P.Road, Aundh, Pune-411007, Maharashtra, India Pune MAHARASHTRA
9850082614
sudhakargrandhi.pentagon@gmail.com
Dr Mamta Patil
Ojas Multispeciality Hospital
Clinical Research Room, Ground floor, Ojas Multispeciality Hospital,Sr.no 230/1, D.Y. Patil College Road, Ravet, Pune-412101, Maharashtra , India Pune MAHARASHTRA
7738927929
mamata.ojas@gmail.com
Dr Makwana Miss Dhwaniben Ranchhodbhai
Parth Hospital
Room no.401 & 402, Research Department, E/405-4, 407-411, Fourth floor Galaxy arcade, near Galaxy cinema, Naroda-382330, Gujarat, India Ahmadabad GUJARAT
9662333253
dhwanimakwanacr722@gmail.com
Dr Pranali Rathod
Saideep Healthcare and Research Private limited
Fourth Floor, Clinical Research Department, Saideep Healthcare and research Private limited, Viraj Estate, behind Yashwant colony, Near DSP chowk, Ahmednagar-414003, Maharashtra, India Ahmadnagar MAHARASHTRA
7721929058
pranalirathod725@gmail.com
Dr Sudhir Singh
Shalinitai Meghe Hospital and Research Centre
Ground floor, Clinical research room, building C, Shalinitai Meghe Hospital and research centre, Wanadongri, Hingna road, Nagpur-441110, Maharashtra, India Nagpur MAHARASHTRA
8806187862
sudhirderma@gmail.com
Dr Chetan Lalseta
Shree Giriraj Multispeciality Hospital
First Floor, CRC Department, A unit of Giriraj Lifecare Private Limited, 27- Navjyot park, 150ft Ring road, Rajkot- 360005, Gujarat, India Rajkot GUJARAT
9825199585
chetanlalseta@gmail.com
Dr Rashmi Singh
Shubham Sudbhawana Superspeciality Hospital
Third Floor, Clinical Research Department, Shubham Sudbhawana Superspeciality Hospital B 31/80, 23-B, Bhogabeer, Lanka, Varanasi-221005, Uttar Pradesh, India Varanasi UTTAR PRADESH
7080063652
sweetrashmi4364@gmail.com
Dr Subhash Bharti
Vedant Multispecialty Hospital
Clinical Research Department , Cabin no. 1 and 2, Basement Floor, Vedant Multispecialty Hospital, GP 83,Sambhaji Nagar, MIDC, Chinchwad, Pune- 411019, Maharashtra, India Pune MAHARASHTRA
9999883007
drsubhashbharti.vedant@gmail.com
Dr Parag Kalyani
Villoo Poonawala Hospital
Room no:13, Basement, Clinical Research Department, Villoo Poonawala Memorial Hospital, Pune - Solapur Road, Near Savli, Corner, Hadapsar, Pune - 411028, Maharashtra, India Pune MAHARASHTRA
Gel vehicle of test product manufactured by Encube Ethicals Private Limited, India.
Subjects will be instructed to apply the Investigational Product once a day. Subjects will cleanse the face with a mild or soapless, non-medicated cleanser, dry skin gently, wait for 20 to 30 minutes before applying the study medication, and then apply enough product to lightly cover the entire affected areas of the face once daily at bedtime for 84 consecutive days.
Comparator Agent
Retin-A Micro® (Tretinoin) Gel Microsphere 0.06% manufactured by Valeant Pharmaceuticals International, Inc.
Laval, Quebec H7L 4A8, Canada and manufactured for Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, USA.
Subjects will be instructed to apply the Investigational Product once a day. Subjects will cleanse the face with a mild or soapless, non-medicated cleanser, dry skin gently, wait for 20 to 30 minutes before applying the study medication, and then apply enough product to lightly cover the entire affected areas of the face once daily at bedtime for 84 consecutive days.
Intervention
Tretinoin Gel Microsphere, 0.06% manufactured by Encube Ethicals Private Limited, India.
Subjects will be instructed to apply the Investigational Product once a day. Subjects will cleanse the face with a mild or soapless, non-medicated cleanser, dry skin gently, wait for 20 to 30 minutes before applying the study medication, and then apply enough product to lightly cover the entire affected areas of the face once daily at bedtime for 84 consecutive days.
Inclusion Criteria
Age From
12.00 Year(s)
Age To
40.00 Year(s)
Gender
Both
Details
1. Healthy male or non-pregnant, non-lactating female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of Acne vulgaris (AV).
2. On the face, having ≥ 20 inflammatory (i.e., papules and pustules), ≥ 25 non-inflammatory (i.e., open and closed comedones) lesions and ≤ 2 nodulocystic lesions (i.e, nodules and cysts).
3. Investigator’s Global Assessment (IGA) of acne severity grade 2, 3 or 4.
4. Willing to refrain from use of all other topical products (moisturizer, new brands of make-up, creams, lotions, powders or any other topical product), all acne medications and antibiotics during the 12 weeks treatment period.
5. Female subjects of child bearing potential practicing an approved method of contraception and willing to continue its use from study entry to 7 days after completion of the last administration of Investigational Product and have a negative Urine Pregnancy Test at the time of screening
or
Female subjects of non-child bearing potential.
Note: Approved methods of contraception include Hormonal contraception including oral, systemic injectable or Intra-uterine Contraceptive Devices (subject must have been on a stable dose for 3 months prior to study entry), bilateral tubal ligation or tubectomy, non-hormonal IUCD, double barrier or strict abstinence.
Use of oral contraceptive therapy is allowed if it shall remain constant throughout the study. Non-child bearing potential is defined as pre-menarche, postmenopausal absence of menstrual bleeding for 1 year prior to enrolment, hysterectomy or bilateral oophorectomy.
6. Male subjects must use accepted methods of birth control or must agree to practice abstinence from study entry to 7 days after the completion of last administration of Investigational Product.
7. Willing to provide written informed consent or assent, as applicable. For subjects who are considered minors (< 18 completed years), the parent or legal guardian shall sign the consent form and the child shall be required to sign a subject “assent†form, as appropriate.
ExclusionCriteria
Details
1. 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).
2. Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that shall interfere with diagnosis or assessment of Acne Vulgaris. Well-trimmed moustaches are allowed.
3. History of hypersensitivity or allergy to tretinoin, retinoids and/or any of the study medication ingredients.
4. 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).
5. Use for less than 3 months prior to baseline (Randomisation) of estrogens or oral contraceptives or any other hormonal therapy; use of such therapy is allowed if it shall remain constant throughout the study.
6. Use on the face within 1 month prior to baseline (Randomisation) cryo-destruction or chemo-destruction, dermabrasion / microdermabrasion, photodynamic therapy, acne surgery, intralesional steroids, X-ray therapy, chemical or laser peel.
7. Use within 1 month prior to baseline (Randomisation) of androgen receptor blockers for acne (spironolactone, Flutamide etc.,), systemic steroids (Including intra-nasal and in-haled corticosteroids), systemic antibiotics, systemic treatment for Acne Vulgaris (other than oral retinoids, which require a 6-month washout) or systemic anti-inflammatory agents.
8. Use within 2 weeks prior to baseline (Randomisation) of topical steroids, topical retinoids and topical acne treatments including over-the-counter preparations, topical anti-inflammatory agents, medicated cleansers/shampoo or topical antibiotics.
9. Use within 2 weeks prior to baseline (Randomisation) of abradants, facials, peels containing glycolic or other acids, masks, washes or soaps, containing glycolic acid, salicylic acid, Alpha- or beta-hydroxy acids or other acids, benzoyl peroxide (BPO) or sulfacetamide sodium, non-mild facial cleansers, moisturizers that contained retinol.
10. Subjects who have undergone a facial procedure (e.g., laser peel, microdermabrasion or blue light treatment, etc.) within the past 4 weeks or if it is planned to be performed during the conduct of the study.
11. Concomitant use/planned to use of mega-doses of certain vitamins (such as mega-doses of vitamin D [> 2000 IU/day], vitamin B6 [> 2 mg] or vitamin B12 [> 1 mg/day]), haloperidol, halogens such as iodide and bromide, lithium, hydantoin and phenobarbital.
12. Use of tanning booths or tanning lamps or ultraviolet light within 1 week prior to Baseline and an unwillingness to refrain from use during the study.
13. Subjects with planned unprotected and intense UV exposure during the study (mountain sports, UV radiation, sunbathing, etc.).
14. A significant medical history of or are currently immunocompromised or receiving immunomodulators/biologics since last 3 months.
15. Subjects with clinically significant vital sign abnormality.
16. Subjects with clinically significant unstable medical disorders, life-threatening disease, or current malignancies.
17. Subjects who engage in activities that involve excessive or prolonged exposure to sunlight or weather extremes, such as wind or cold.
18. History of drug or alcohol abuse within last 6 months.
19. Lived in the same household as currently enrolled subjects.
20. Female subjects who are breast-feeding or planning to become pregnant.
21. Subjects who have been treated with an investigational drug or investigational device within a period of 30 days prior to study enrolment.
22. Subjects with a clinically significant disease(s) or disorder(s) other than facial Acne Vulgaris that in the opinion of the Investigator may (i) put the subject at risk because of participation in the study (ii) interfere with the study evaluations or (iii) cause concern regarding subject’s ability to participate in 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 12 in the inflammatory (papules and pustules) lesion count
Mean percent change from baseline to week 12 in the Non-inflammatory (open and closed comedones) lesion count.
Baseline to week 12
Baseline to week 12
Secondary Outcome
Outcome
TimePoints
Proportion of subjects with a clinical response of “success†at week 12.
week 12 (Day 84)
Target Sample Size
Total Sample Size="981" Sample Size from India="981" Final Enrollment numbers achieved (Total)= "0" Final Enrollment numbers achieved (India)="0"
A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Three-arm, Parallel Study to Evaluate the Bioequivalence using Clinical Endpoint of Tretinoin Gel microsphere, 0.06% in the Treatment of 981 Subjects with Subjects with Acne Vulgaris. At screening/baseline visit, subjects shall be randomly (Double’blind) assigned in 1:1:1 fashion to one of the 3 treatment groups at visit 1. Statistical comparisons shall be made between test and reference, test and placebo, and reference and placebo. The primary endpoint is test/reference ratio of the mean percent change from baseline to week 12 in the inflammatory (papules and pustules) and non- inflammatory (Comedones) lesion count at Visit 5.The secondary endpoint is the proportion of subjects who are considered a Clinical Success at Week 12. Safety shall be evaluated from reported adverse events and application site reaction assessments.