| CTRI Number |
CTRI/2011/07/001878 [Registered on: 12/07/2011] 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 Trial |
|
Public Title of Study
|
A three arm study Compare Efficacy and Safety Evaluation of Tacrolimus 0.1% Topical Ointment Formulations in atopic dermatitis . |
|
Scientific Title of Study
|
A Randomized, Investigator-Blind, Three-arm, Parallel Assignment, Multi-centre, Comparative Efficacy and Safety Evaluation of Three Tacrolimus 0.1% Topical Ointment Formulations |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 081-11 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prashant Gudadhe |
| Designation |
Project manager |
| Affiliation |
Lambda Therapeutic Research pvt Ltd |
| Address |
Lambda Therapeutic Research pvt Ltd,Mumbai
NIL
Mumbai
MAHARASHTRA
400614
India |
| Phone |
|
| Fax |
|
| Email |
prashantgudadhe@lambda-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Praveen Shetty |
| Designation |
Asst Manager |
| Affiliation |
Lambda Therapeutic Research pvt Ltd |
| Address |
Lambda Therapeutic Research pvt Ltd, Ahmedabad
Ahmadabad
GUJARAT
380061
India |
| Phone |
|
| Fax |
|
| Email |
praveenshetty@lambda-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Praveen Shetty |
| Designation |
Asst Manager |
| Affiliation |
Lambda Therapeutic Research pvt Ltd |
| Address |
Lambda Therapeutic Research pvt Ltd, Ahmedabad
Ahmadabad
GUJARAT
380061
India |
| Phone |
|
| Fax |
|
| Email |
praveenshetty@lambda-cro.com |
|
|
Source of Monetary or Material Support
|
| Intas Pharmaceuticals Ltd- Ahmedabad |
|
|
Primary Sponsor
|
| Name |
Intas Pharmaceuticals Ltd Ahmedabad |
| Address |
2nd Floor, Chinubhai Center, Ashram Road, Ahmedabad- 380 009,Gujarat, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nayan Patel |
Ashadeep Hospital |
Patel Chamber ground and 3rd floor, Behind Dariyapur Darwaza-Ahmedabad-380001
Ahmadabad
GUJARAT |
0792640302
Patelnayan78@rediffmail.com |
| Dr D G Saple |
Dr. D. G. Saple Clinic |
88, Hindu Colony, 3rd Lane, Dadar(E)- Mumbai-400014
Mumbai
MAHARASHTRA |
022-24143895
sapleclinic@gmail.com |
| Radiance Skin Clinic |
Dr. Rizwan Haq |
Behind sadar bus stop, Tekdi road,Opp sadar Muslim Library-Nagpur-440001 Phone: 0712-3210803
Nagpur
MAHARASHTRA |
0712210803
drrizwanhaq@yahoo.co.in |
| Trivedi skin care clinic and cosmetic leaser centre |
Dr. Sunil Trivedi |
102 swapna srusti complex, Near Sai Baba Mandir, Opp. T.V.S Auto Point, Parvat Patiya-Surat- 395010
Ahmadabad
GUJARAT |
026123444
drsuniltrivedi@gmail.com |
| Sparsh Hospital and policlinic |
Dr. Sushil Pande |
Om sai apartment, 1st floor,78, Vidyavihar, Pratap Nagar-Nagpur-44002
Nagpur
MAHARASHTRA |
0712289955
drsushilpande@gmail.com |
| Dr Vikrant Saoji Skin Clinic |
Dr. Vikrant Saoji |
Nav prabhat chamber,27, Ramdas peth , Central Bazar Road-Nagpur-440010
Nagpur
MAHARASHTRA |
0712-2423329
vikrantsaoji@hotmail.com |
| Dr Bhavik Bhavasr |
Lavanya Skin Clinic |
303, Aishwarya Complex,Above U.S. Pizza, Jawahar Chowk Ahmedabad-380006
Ahmadabad
GUJARAT |
09825953263
bhavik.bhavsar78@gmail.com |
| Dr M Vaghasiya |
Shri Hari skin care |
501 Param Doctor House,Near Resam Bhavan,Lal Darwaja Station Road-Surat-395003
Surat
GUJARAT |
0261241000
shrihari.skincare@yahoo.com |
| Dr GM Vinod |
Vallabh Park Hospital |
V.S. hospital, A/2-115 Vallabh Park,Near Hariomnagar, Ellora Park-Vadodara-390 023
Vadodara
GUJARAT |
2652390300
gmvinod2004@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Clinical Ethics Forum, Mumbai (Dr. D. G. Saple) |
Approved |
| Clinical Ethics Forum, Mumbai (Dr. Rizwan Haq) |
Approved |
| Clinical Ethics Forum, Mumbai (Dr. Vikrant Saoji) |
Approved |
| IEC - NKPSIMS & RC, Nagpur (Dr. Sushil Pande) |
Approved |
| Independent Ethics Committee,Dr. Bhavik Bhavsar |
Approved |
| Independent Ethics Committee,Dr. Mahendra Vaghasiya |
Approved |
| Independent Ethics committee,Dr. Nayan Patel |
Approved |
| Independent Ethics committee,Dr. Sunil Trivedi |
Approved |
| Independent Ethics Committee,DrGhanshyam Mukundrao Vinod |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L209||Atopic dermatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Protopic® (Tacrolimus Monohydrate) Ointment 0.1% manufactured by Astellas Pharma B.V., The Netherlands and marketed by Astellas Pharma Europe Ltd. |
Treatment applied as a thin layer gently using finger(s) to all affected areas (a 1 cm ribbon spread is recommended over approx. 100 cm2 skin surface) twice daily for up to 3 weeks regardless of the clearance of lesions in-between. Patient will be advised to wear appropriate protective clothing and take measures to avoid sun exposure to the treated areas. |
| Intervention |
Test Drug (1): Tacrolimus Monohydrate Ointment 0.1% manufactured by Intas Pharmaceuticals Ltd., India. |
Treatment applied as a thin layer gently using finger(s) to all affected areas (a 1 cm ribbon spread is recommended over approx. 100 cm2 skin surface) twice daily for up to 3 weeks regardless of the clearance of lesions in-between. Patient will be advised to wear appropriate protective clothing and take measures to avoid sun exposure to the treated areas. |
| Intervention |
Test Drug (2): Tacrolimus Monohydrate Ointment 0.1% manufactured by Intas Pharmaceuticals Ltd., India. |
Treatment applied as a thin layer gently using finger(s) to all affected areas (a 1 cm ribbon spread is recommended over approx. 100 cm2 skin surface) twice daily for up to 3 weeks regardless of the clearance of lesions in-between. Patient will be advised to wear appropriate protective clothing and take measures to avoid sun exposure to the treated areas. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or non-pregnant, non-lactating female of any ethnic group, 18 – 70 years of age (both inclusive) at the time of signing the informed consent.
2. Patients having atopic dermatitis according to Hanifin and Rajka diagnostic criteria (Appendix I).
3. Patients with a grading of moderate to severe AD (i.e. a score of at least 4.5) as defined by the scoring system of Rajka and Langeland (Appendix II).
4. Non-immunocompromised adults who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable. [19]
5. Both male and female patients of child bearing potential must be practicing adequate contraception and female patients of child-bearing potential must not be/likely to be pregnant or lactating and must have a negative serum pregnancy test at screening and negative urine pregnancy test at randomization.
6. Patient is capable of understanding the purposes and risks of the trial and has given written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
7. Patient has not taken and agrees not to take any medication or therapy prohibited by the protocol for the entire study period.
|
|
| ExclusionCriteria |
| Details |
1. Newly diagnosed patients.
2. Patients with very severe atopic dermatitis requiring systemic therapy for AD.
3. Clinically infected atopic dermatitis at the baseline visit.
4. Any dermatological condition other than atopic dermatitis as scar/wound/tattoo at the application site or in its close vicinity that in the investigators opinion may interfere with the evaluation of the patients atopic dermatitis.
5. Patient who have not had a minimum washout phase (prior to randomization) as follows:
• 5 days: medicated topical agents, systemic antihistamines and sedatives
• 7 days : intranasal or inhaled corticosteroids employed 1 mg/day
• 4 weeks: systemic corticosteroids and nonsteroidal immunosuppressants
• 6 weeks: UV treatments
6. History of allergy or hypersensitivity to tacrolimus or any of the ointment excipients, pimecrolimus, any macrolides such as clindamycin, erythromycin, azithromycin, clarithyromycin etc.
7. History or known case of congenital or acquired immunodeficiencies, which in the investigator’s opinion would contraindicate the use of immunosuppressants, including but not limited to human immunodeficiency virus (HIV) infection and cancer.
8. Patient with a known case of genetic epidermal barrier defect such as Netherton’s syndrome or generalised erythroderma.
9. Patients with a known case of Cushing’s syndrome.
10. Patients with diagnosed hepatic failure:
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary objective is to assess the therapeutic response of two test formulations and a reference formulation of tacrolimus 0.1%. |
The primary objective is to assess the therapeutic response of two test formulations and a reference formulation of tacrolimus 0.1%. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary objectives are to describe the safety profile of the three ointments and to investigate their systemic absorption at steady state. |
NIL |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
18/07/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Atopic dermatitis (AD) is an inflammatory skin disease with a chronically relapsing course, is characterized by episodes of intense pruritus, lichenification, severely dry skin, and a susceptibility to cutaneous infections.
AD is a common skin disease that occurs in persons of all ages. It has increased in prevalence worldwide two- to threefold over the last 50 years.
For almost half a century, conventional management of AD has been based on the use of emollients to alleviate dry skin, coupled with short courses of topical corticosteroids to treat flares. The short-term efficacy of topical corticosteroids in controlling acute symptoms of AD is well established
Although topical corticosteroids are generally well tolerated, they commonly cause skin atrophy and less frequently cause hypopigmentation, secondary infections, and acne
Tacrolimus ointment preparation is an effective alternative to patients
suffering from AD as it has unique mechanism of action. Tacrolimus, a
macrolide immunomodulator, is believed to control atopic dermatitis by
inhibiting T lymphocyte activation, altering cell surface expression on
antigen-presenting dendritic cells and modulating the release of
inflammatory mediators from skin mast cells and basophils. Both short- and
long-term monotherapy with tacrolimus 0.03 and 0.1% ointment improves
moderate to severe atopic dermatitis in adult and pediatric patients. Topical
tacrolimus ointment is well tolerated, with the majority of adverse events
being localized, transient in nature and of mild or moderate severity.
Tacrolimus ointment provides a promising addition to the currently available
treatments for atopic dermatitis.
The results of the pivotal efficacy studies indicate that tacrolimus is
efficacious in the treatment of acute flares of moderate to severe AD and that the benefit is seen within a few days following commencement of treatment.
In the adult population, the higher concentration (0.1%) showed a better
efficacy than 0.03 %. It also seems that patients treated with the higher concentration heal faster. Twice-daily application is more efficacious than once daily application in the first two weeks. Further, patients with atopic dermatitis most likely tend to treat their disease when it is active and will modify the regimen as the condition heals either deliberately or because of poor compliance
The primary objective is to assess the therapeutic response of two test formulations and a reference formulation of tacrolimus 0.1%.
The secondary objectives are to describe the safety profile of the three ointments and to investigate their systemic absorption at steady state. |