| CTRI Number |
CTRI/2020/02/023490 [Registered on: 20/02/2020] Trial Registered Prospectively |
| Last Modified On: |
05/02/2020 |
| 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 trial to study the effect of three drugs Adapalene Gel USP, 0.1 %, Differin® (Adapalene) Gel, 0.1% and Placebo topical gel in healthy males and nonpregnant female subjects with acne vulgaris |
|
Scientific Title of Study
|
A randomized, double blind, placebo controlled, parallel group design, three arm, multicentric study to evaluate the efficacy and safety of topical Adapalene Gel USP, 0.1 % in healthy males and nonpregnant female subjectswith acne vulgaris [Group I (Test): Adapalene Gel USP, 0.1 %; Group II (Reference): Differin® (Adapalene) Gel, 0.1%; and Group III: Placebo] |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CR191-18 Version 1.0, 09.10.2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Subhra Lahiri |
| Designation |
Associate Vice President |
| Affiliation |
Axis Clinicals Limited |
| Address |
Axis Clinicals Ltd
1-121/1 Miyapur
Hyderabad
TELANGANA
500049
India |
| Phone |
8886221089 |
| Fax |
04040408060 |
| Email |
Subhra.L@axisclinicals.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subhra Lahiri |
| Designation |
Associate Vice President |
| Affiliation |
Axis Clinicals Ltd |
| Address |
Axis Clinicals Ltd
1-121/1 Miyapur
Hyderabad
TELANGANA
500049
India |
| Phone |
8886221089 |
| Fax |
04040408060 |
| Email |
Subhra.L@axisclinicals.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Subhra Lahiri |
| Designation |
Associate Vice President |
| Affiliation |
Axis Clinicals Ltd |
| Address |
Axis Clinicals Ltd
1-121/1 Miyapur
Hyderabad
TELANGANA
500049
India |
| Phone |
8886221089 |
| Fax |
04040408060 |
| Email |
Subhra.L@axisclinicals.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Aurobindo Pharma |
| Address |
2929 Weck Dr
Durham NC 27709 USA
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Axis Clinicals Limited |
1-121/1, Miyapur, Hyderabad |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 24 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ipsa Pandya |
Amena Khatun General Hospital |
Sarkhej Road, Ahmedabad380055 Gujarat India
Ahmadabad
GUJARAT |
9904704445
niip257@yahoo.in |
| Dr Radha sha |
Apollo Hospital, |
Road No 72 Opp. Bharatiya Vidya Bhavan School Film Nagar, Jubilee Hills Hyderabad Telangana 500033
Hyderabad
TELANGANA |
8008883368
drradhashah@gmail.com |
| Dr Indrashis Podder |
College of Medicine & Sagore Dutta Hospital |
BT Road Kamarhati Kolkata-700058
Kolkata
WEST BENGAL |
9007977161
ipodder88@gmail.com |
| Dr Riyaz |
Cresent Hospital and Heart Center |
Plot No 5 1st Lane Behind Old Mount Carmel School Dhantoli Lokmat Square
Nagpur
MAHARASHTRA |
9822701123
riyazaamir15@gmail.com |
| Dr Bikash ranjan kar |
Department of Skin & VD Institute of Medical Sciences |
Department of Skin and VD Inistitute of medical sciences (IMS) & sum hospital,k8-kalinga nagar, Ghatikia, Bhuvaneshwar 751003
Khordha
ORISSA |
9937428181
karbikash@gmail.com |
| Dr Sharmila Patil |
DR. D.Y Patil Hospital |
Sector-05,Navi Mumbai 400706
Mumbai
MAHARASHTRA |
9821350217
drsharmilapatil@gmail.com |
| Dr Veeresh V Dyavannanavar |
Gadag institute of medical Sciences |
Gadag Institute of Medical Sciences is a medical college Mallasamudra, Mulgund Road,Gadag 582103
Gadag
KARNATAKA |
7406238996
Veeresh83@gmail.com |
| Dr Usha Khemani |
Gokuldas Tejpal Hospital, Grant Govt Medical College and JJ Group Hospital |
Near Police Commissioners Office, Lokmanya Tilak Marg, Fort, G. P. O, Mumbai, Maharashtra 400001
Mumbai
MAHARASHTRA |
984059301
ushakhemani@gmail.com |
| DrJayesh I mukhi |
Govt of medical college & hospital |
Department of Skin LeprologyNagpur-440003 Maharashtra
Nagpur
MAHARASHTRA |
9665037576
jayesh.mukhi@rediffmail.com |
| Dr KC Nischal |
Gurushree Hi-Tech Multi-Specialty Hospital |
No.1558, Opp. Chandra lay out bus Stand Chandra lay out Vijaya Nagar Bangalore-560040
Bangalore
KARNATAKA |
9825199585
drnischal@nirmalskinclinic.com |
| Dr BangaruH |
K.R Hospital Mysore Medical College |
K.R Hospital Mysore Medical College MMC&RI mysore Karnataka 570001
Mysore
KARNATAKA |
9886789231
drbangaruskin@gmail.com |
| Dr T Sundar Sahoo |
Kalinga Institute of Medical Sciences |
Kalinga Institute of Medical Sciences Kushabhadro Campus Nateia Bhusbaneswar 757074
Khordha
ORISSA |
7381041755
drtsundarsahoo@gmail.com |
| DrJayashree Savalia |
Kiran Hospital Multi Super Specialty Hospital |
Near sumul dairy Surat Gujarat 395004
Surat
GUJARAT |
9979530073
jayshreesavalia@gmail.com |
| DrTK Sumathy |
M.S. Ramaiah Medical College & Hospital |
M S Ramaiah Nagar, Mathikere, Bengaluru Karnataka 560054
Bangalore
KARNATAKA |
9845163009
tksumathy@gmail.com |
| Priyanka Magia |
Meditrina Institute of Medical Sciences |
Central Bazar Road Ramdainpeth Nagpur
Nagpur
MAHARASHTRA |
8600006281
drmagiapriyanka@gmail.com |
| Dr Sham Agarwal |
Rao Nursing Hospital |
SurveyNo 691A/1A-1CTS No.1897-B Pune-Satara-Road Bibwewadi Pune-411037
Pune
MAHARASHTRA |
9422026123
drshaam@rediffmail.com |
| DrBhavik Bhavsar |
Shivam Hospital |
Society, Nr. Gor’s Kuva, Nr. Jashoda nagar Cross Road, Maninagar(E), Ahmedabad-380008
Ahmadabad
GUJARAT |
9825953263
bhavik.bhavsar78@gmail.com |
| DrKriti Shah |
Shreeji hospital |
NrVisat petrol pump ONGC Avani bhavan Sabarmati Ahmedabad Gujarat 380005
Ahmadabad
GUJARAT |
9825651751
dr.kirtipshah@yahoo.com |
| DrYakariVinodini |
St. Theresas Hospital |
Department of Clinical Research Erragadda Sanathnagar Hyderabad Telangana Hyderabad 500018
Hyderabad
TELANGANA |
9030019699
vinskin_vy@gmail.com |
| Dr Akansh Jain |
Sunshine Hospital |
PG Road Paradise Secundarbad 500003 Telangana
Hyderabad
TELANGANA |
9966553244
Akanshjain001@gmail.com |
| Dr Sheena Singh |
Tristar multispecialty hospital |
Opp T&TV high school Nanpura, Surat-395001
Surat
GUJARAT |
9632162827
Singh.sheenaa@gmail.com |
| DrNikitha jadhav |
Vijay Vallabh hospital Medical research center |
423,Tirupathi nagar,phase 1bolinjVirar(west),Dist Palghar,Pin 401303 Mumbai
Mumbai
MAHARASHTRA |
7030333226
dr.nikitajadhav@gmail.com |
| Dr Keyur shah |
Vrajesh Hospital |
Bodakdev Ahmedabad Gujarat 380015
Ahmadabad
GUJARAT |
9879004822
drkeyurshah@yahoo.com |
| Dr Manjunath Shenoy |
Yenepoya Medical college Hospital , |
Yenepoya Medical college Hospital univercity road.Deralakat Mangalore 575018
Dakshina Kannada
KARNATAKA |
9845009976
manjunath576117@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 24 |
| Name of Committee |
Approval Status |
| Amena khatun hospital Ethics committee |
Submittted/Under Review |
| Cresent Hospital Institutional Ethics Committee |
Submittted/Under Review |
| Ethics Committee MS Ramaiah Medical College and Hospital |
Submittted/Under Review |
| Ethics committee of Shreeji Hospital |
Submittted/Under Review |
| Ethics committee Rao Nursing Home |
Approved |
| GIMS ethical Committee |
Submittted/Under Review |
| Institutional Ethics committee |
Submittted/Under Review |
| Institutional Ethics committee |
Submittted/Under Review |
| Institutional Ethics committee |
Submittted/Under Review |
| Institutional Ethics committee |
Submittted/Under Review |
| Institutional Ethics committee |
Submittted/Under Review |
| Institutional Ethics committee |
Submittted/Under Review |
| Institutional Ethics committee |
Submittted/Under Review |
| Institutional Ethics committee Kalinga Institute of Medical Sciences |
Submittted/Under Review |
| Institutional Ethics committee Mysore Medical College and Research Institute |
Submittted/Under Review |
| Institutional Ethics committee of IMS and SUM hospital |
Submittted/Under Review |
| Institutional Ethics committee Sun Shine hospital |
Submittted/Under Review |
| Institutional Ethics Committee-Clinical Studies |
Submittted/Under Review |
| Kiran Hospital Ethics committee |
Approved |
| Meditrina Institutional Ethics committee |
Submittted/Under Review |
| Shivam Ethics committee |
Submittted/Under Review |
| Tristar Hospital Ethics Committee |
Submittted/Under Review |
| Vrajesh Institutional Review Board |
Submittted/Under Review |
| Yenepoya Ethics Committee |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L700||Acne vulgaris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Adapalene Gel USP, 0.1% |
He/ she needs to apply a thin film of either Test gel once daily to the entire face once daily in evening for 12 weeks after cleaning the face with a mild or soapless, non-medicated cleanser, pat dry. |
| Comparator Agent |
Differin® (Adapalene) Gel, 0.1% |
He/ she needs to apply a thin film of either Reference gel once daily to the entire face once daily in evening for 12 weeks after cleaning the face with a mild or soapless, non-medicated cleanser, pat dry. |
| Intervention |
Placebo |
He/ she needs to apply a thin film of Placebo gel once daily to the entire face once daily in evening for 12 weeks after cleaning the face with a mild or soapless, non-medicated cleanser, pat dry. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Healthy male or non-pregnant female aged between ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris
Subject having ≥ 25 non-inflammatory lesions (i.e., open and closed comedones) and ≥ 20 inflammatory lesions (i.e., papules and pustules) and ≤ 2 nodulocystic lesions (i.e., nodules and cysts) on the face
Subject having clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per IGA scale in Appendix-3
Subject willing to refrain from use of all other topical acne medications or antibiotics during the 12 week treatment period
Subject/ LAR willing to give their written informed consent (incase of subject with age ≥ 18 years) and written informed assent (incase of subject < 18 years) to participate in the study
Female of childbearing potential, willing to use an acceptable form of birth control during the study
|
|
| ExclusionCriteria |
| Details |
Subject having 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, acne form eruptions caused by medications, steroid acne, steroid folliculitis or bacterial folliculitis)
Subject having excessive facial hair (e.g. beards, sideburns, moustaches etc.) that would interfere with diagnosis or assessment of acne vulgaris
Subject with history of hypersensitivity or allergy to Adapalene, retinoids and/or any of study medication ingredients or anaphylactoid/anaphylactic reactions (e.g., skin rash, pruritus, hives, chest pain, edema, and shortness of breath)
Subject used oral retinoids (e.g. Accutane®) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed) within 6 months prior to baseline
Subject used estrogens or oral contraceptives for less than 3 months prior to baseline; use of such therapy must remain constant throughout the study
Subject used cryodestruction or chemodestruction, dermabrasion, photodynamic therapy, acne surgery, intralesional steroids, or x-ray therapy on face within 1 month prior to baseline or planning to use during the study
Subject used systemic steroids, systemic antibiotics, systemic treatment for acne vulgaris (other than oral retinoids, which require a 6 month washout), or systemic anti-inflammatory agents within 1 month prior to baseline or planning to use during the study
Subject used topical steroids, topical retinoids, topical acne treatments including over-the-counter preparations, topical anti-inflammatory agents, or topical antibiotics within 2 weeks prior to baseline or planning to use during the study
Subject who is planning to use spironolactone during the study
Subject who had participated in another investigational drug or device research study within 30 days of enrolment
Subject who used any medication or has any disease which in the judgment of the Investigator will interfere with the conduct or interpretation of the study
Female subject who is pregnant, nursing or planning a pregnancy during the study
Subject who is using preparations containing sulfur, resorcinol, or salicylic acid
Subject with known history of HIV, HBsAg and HCV
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator 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. |
Visit 2, 3, 4 and 5 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Proportion of subjects with a clinical response of success at week 12.
Percentage of subjects who achieved at least 50 % reduction in lesion counts (inflammatory, non-inflammatory and total lesion count) at week 12.
|
Visit 2, 3, 4 and 5 |
|
|
Target Sample Size
|
Total Sample Size="980"
Sample Size from India="980"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/03/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomized, double blind, placebo-controlled,
three-arm, parallel group, multi-centric study to evaluate the efficacy and safety of Adapalene Gel USP, 0.1 % in subjects with acne vu-lgaris [Group
I (Test): Adapalene Gel USP, 0.1 %;
Group II (Reference): Differin® (Adapalene) Gel, 0.1%; and Group
III: Placebo].
A total of
five visits will be scheduled to the investigator site [i.e., Screening/
Randomization Visit-1 (Day 0), On-treatment visits (Visit -2-Day 14, Visit-3-
Day 28 and Visit 4- Day 56) and the End of Study (EOS) Visit-5 (Day 85)]. There
will be window period of ± 4 days for each visit. Two subjects from same household will not be enrolled in
the study.
All
subjects will be reported to the study site for screening. After completion of
the required screening tests and procedures, subjects meeting all the inclusion
criteria and none of the exclusion criteria will be randomized and the day will
be considered as Day 0. Subjects will be provided with study medication (either
Test or Reference or Placebo in 2:2:1 ratio as per the randomization schedule).
He/ she needs to apply
a thin film of either Test or Reference or Placebo gel once daily to the entire
face once daily in evening for 12 weeks after cleaning the face with a
mild or soapless, non-medicated cleanser, pat dry.
Subjects need to report to the Investigator site on day 14, day 28
and day 56 with window
period of ± 4 days for each visit. At these visits,
efficacy and safety evaluation will be done. Subjects will go through all the
end of study evaluation procedures on end of study visit (Day 85). |