| CTRI Number |
CTRI/2017/02/007835 [Registered on: 13/02/2017] Trial Registered Prospectively |
| Last Modified On: |
24/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study to evaluate the Efficacy, Safety and Tolerability of Ivermectin Cream 1% w/w Vs. Azelaic Acid Gel 15% w/w in Patients with Inflammatory Lesions of Rosacea. |
|
Scientific Title of Study
|
A Comparative, Randomized, Two Arm, Multicentric, Active Controlled, Open label, Parallel Group, Phase III Study to Evaluate the Efficacy, Safety and Tolerability of Ivermectin Cream 1% w/w Vs. Azelaic Acid Gel 15% w/w in Patients with Inflammatory Lesions of Rosacea. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| APL/CT/16/03 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rashmi Sarkar |
| Designation |
Principal Investigator |
| Affiliation |
Maulana Azad Medical College |
| Address |
Maulana Azad Medical College,
2, Bahadur Shah Zafar Marg,
New Delhi.
North
DELHI
110002
India |
| Phone |
110002 |
| Fax |
|
| Email |
rashmisarkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shailesh Singh |
| Designation |
Vice President R&D and Reg. Affairs |
| Affiliation |
Ajanta Pharma Ltd |
| Address |
Ajanta Pharma Ltd Advent 43AB/44CD Charkop Industrial Estate Kandivli West, Mumbai
MAHARASHTRA.
Mumbai
MAHARASHTRA
400067
India |
| Phone |
022-6062111 |
| Fax |
|
| Email |
shailesh.singh@ajantapharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shailesh Singh |
| Designation |
Vice President R&D and Reg. Affairs |
| Affiliation |
Ajanta Pharma Ltd |
| Address |
Ajanta Pharma Ltd Advent 43AB/44CD Charkop Industrial Estate Kandivli West, Mumbai
MAHARASHTRA.
Mumbai
MAHARASHTRA
400067
India |
| Phone |
022-6062111 |
| Fax |
|
| Email |
shailesh.singh@ajantapharma.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ajanta Pharma Limited |
| Address |
janta Pharma Ltd
Advent 43AB/44CD Charkop Industrial Estate Kandivli West Mumbai
MAHARASHTRA
400 067
India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shatrughan Sahay |
Ajanta Hospital |
Department of Dermatology,
Ajanta Research Centre, Ajanta Hospital & IVF Centre, 765, ABC Complex, Kanpur Road, Alambagh,
Lucknow-226005.
Uttar Pradesh.
Lucknow
UTTAR PRADESH |
09412119129
dr.shatru@yahoo.com |
| Dr Bela J Shah |
B.J. Medical College & Civil Hospital |
Department of Dermatology,
B.J. Medical College & Civil Hospital,
Asarwa,
Ahmedabad-380016.
Gujarat.
Ahmadabad
GUJARAT |
09898059289
shah.drbela@gmail.com |
| Dr Chitra Nayak |
BYL Nair Hospital & TNMC |
Department of Dermatology,
BYL Nair Hospital & TNMC, AL Nair Road, Mumbai Central, Mumbai-400008, Maharashtra.
Mumbai
MAHARASHTRA |
09819107591
Chitra212@hotmail.com |
| Dr Ramesh Bhat M |
Father Muller Medical College Hospital |
Department of Dermatology,
Father Muller Medical College Hospital, Kankanady,
Mangalore-575002.
Karnataka.
Dakshina Kannada
KARNATAKA |
9845084224
rameshderma@gmail.com |
| Dr Ratnakar Kamath |
Grant Govt. Medical College & Sir J.J Groups of Hospital |
Department of Dermatology
Grant Govt. Medical College & Sir J.J Groups of Hospital, Byculla, Mumbai-400008, Maharashtra
Mumbai
MAHARASHTRA |
02228770542
ratnakar.kamath@gmail.com |
| Dr Kranti Chandan Jaykar |
Indira Gandhi Institute of Medical Sciences |
Department of Skin, VD and Leprosy, Indira Gandhi Institute of Medical Sciences,
Sheikhpura,
Patna-800014.
Bihar.
Patna
BIHAR |
08969953194
drkcjaykar@yahoo.co.in |
| Dr Surjit Singh Mehta |
Maharaja Agrasen Hospital |
Department of Dermatology,
Maharaja Agrasen Hospital, West Punjabi Bagh, New Delhi-110026
New Delhi
DELHI |
01140777555
drsurjitmehta@gmail.com |
| Dr Rashmi Sarkar |
Maulana Azad Medical College |
Department of Dermatology,
Maulana Azad Medical College,
2, Bahadur Shah Zafar Marg,
New Delhi – 110002.
Central
DELHI |
09818244340
rashmisarkar@gmail.com |
| Dr VVV Satyanarayana |
Rajiv Gandhi Institute of Medical Sciences & RIMS Government General Hospital |
Department of Dermatology, Rajiv Gandhi Institute of Medical Sciences & RIMS Government General Hospital
Srikakulam
ANDHRA PRADESH |
09963744345
vellasatyanarayana@gmail.com |
| Dr Meha Malhotra |
Sterling Hospital |
2nd Floor, Department of Dermatology, Sterling Hospital, Sterling Hospital Road, Memnagar, Ahmedabad-380052. Gujarat.
Ahmadabad
GUJARAT |
09904403148
drmehabetai@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Ethics Committee_Ajanta Hospital & IVF Centre |
Approved |
| Ethics Committee_Indira Gandhi Institute of Medical Sciences (IGMS) |
Approved |
| Father Muller Ethics Committee |
Submittted/Under Review |
| Institutional Ethics Committee_B.J. Medical College & Civil Hospital |
Approved |
| Institutional Ethics Committee_Grant government medical college & sir J.J. group of Hospital |
Approved |
| Institutional Ethics Committee_Maharaja Agrasen Hospital |
Approved |
| Institutional Ethics Committee_Maulana Azad Medical College |
Approved |
| Institutional Ethics Committee_RIMS Govt. General Hospital |
Approved |
| Institutional Ethics Committee_Sterling Hospital |
Submittted/Under Review |
| Institutional Ethics committee_Topiwala national medical college and B.Y.L. Nair Hospital |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Inflammatory Lesions of Rosacea, (1) ICD-10 Condition: L089||Local infection of the skin and subcutaneous tissue, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Azelaic Acid Gel 15% w/w |
Apply cream topically on affected areas Twice Daily every possibly at the same time everyday for 85 days.
Total duration of Therapy is 85 Days. |
| Intervention |
Ivermectin Cream 1% w/w |
Apply cream topically on affected areas once Daily every possibly at the same time everyday for 85 days.
Total duration of Therapy is 85 Days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
2. Patients diagnosed with inflammatory lesions of papulopustular rosacea only in central area of the face, T zone and chin with a score of 2 - 4 according to Investigator Global Assessment (IGA).
3. Subjects who would be able to follow the protocol schedules.
4. Free of any clinically significant disease which can potentially interfere with the study. |
|
| ExclusionCriteria |
| Details |
1. Subjects known to be non-responders to Azelaic Acid.
2. Subjects with any bleeding disorders.
3. Subjects with comedogenic and non comedogenic papules and pustules of acne vulgaris.
4. Subjects with particular forms of rosacea (rosacea conglobate, rosacea fulminant, isolated rhinophyma, isolated pustulosis of the chin) or other facial dermatoses that may be confounded with papulopustular rosacea, such as peri oral dermatitis or seborrheic dermatitis and acne.
5. Subjects with rosacea with more than two nodules on the face.
6. Subjects on treatment of Oral Isotretinoin within 6 months.
7. History of any skin diseases and/or ongoing treatment for any other skin related disorder.
8. Any acute and/or chronic systemic disorders which is uncontrolled within last one month (cardiovascular, renal, hepatic, respiratory, gastrointestinal, central nervous system, endocrine).
9. Pregnant or nursing (lactating) women or women with child bearing potential who are not taking acceptable form of contraceptive.
10. Known or suspected hypersensitivity to any drug that will be administered during the study.
11. Inability to comply with the protocol requirements.
12. Participation in any other clinical trial within 3 months of registering in this trial.
13. Medical history of oncological disease within 5 years before screening.
14. Patients with infections of HIV, hepatitis B or C.
15. Patients with history of wasting disease, autoimmune disease, connective tissue disease or History of drug or alcohol abuse within the previous 2 years.
16. Any condition or therapy that in the opinion of the Investigator may pose a risk to the subject or interfere with the evaluation of the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • To evaluate the efficacy of Ivermectin Cream 1% w/w Vs. Azelaic Acid Gel 15% w/w in patients with inflammatory lesions of Rosacea. |
• To evaluate the efficacy of Ivermectin Cream 1% w/w Vs. Azelaic Acid Gel 15% w/w in patients with inflammatory lesions of Rosacea. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the safety and Tolerability of Ivermectin Cream 1% w/w Vs. Azelaic Acid Gel 15% w/w in patients with inflammatory lesions of Rosacea.
• To evaluate the tolerability of Ivermectin Cream 1% w/w Vs. Azelaic Acid Gel 15% w/w in patients with inflammatory lesions of Rosacea. |
• Percentage of patients reporting AE and/or SAE during the study, its frequency, severity, pattern and causal relationship to the drug.
• Local Tolerance Parameters (Stinging/burning, dryness and itching) at each visit evaluated on 4-point scale [from 0 to 3 Severe]. |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
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)
|
14/02/2017 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
No publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This clinical trial is a Comparative,
Randomized, Two Arm, Multicentric, Active Controlled, Open label, Parallel
Group, Phase III Study to Evaluate the Efficacy, Safety and Tolerability of
Ivermectin Cream 1% w/w Vs. Azelaic Acid Gel 15% w/w in Patients with
Inflammatory Lesions of Rosacea. The duration of clinical trial is 85 days for
each patient. The primary outcome of the study is to measure Mean change in the
IGA Score from baseline to Day 85. Safety parameter includes Percentage of
patients reporting AE and/or SAE during the study, its frequency, severity,
pattern and causal relationship to the drug and Local Tolerance Parameters
(Stinging/burning, dryness and itching) at each visit evaluated on 4-point
scale [from 0 to 3 Severe]. |