A study to evaluate effectiveness of Tacrolimus 0.1% Topical Ointment in the patients of the allergic dermatitis.
Scientific Title of Study
A Randomized, Double-Blind, Placebo-controlled, Three-arm, Parallel Assignment, Multi-centre, Therapeutic Equivalence Study of Two Tacrolimus 0.1% Topical Ointment Formulations in Adult Patients with Moderate to Severe Atopic Dermatitis
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
311-09, version 02 of 30 January 2012
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Sheejith K
Designation
Project Manager
Affiliation
Lambda Therapeutic Research Ltd.
Address
Lambda Therapeutic Research Ltd.
Plot No. 38, Near Silver Oak Club, S. G. Highway, Gota,
Ahmedabad – 380 061,
Gujarat,
India NIL Ahmadabad GUJARAT 380 061 India
Phone
917940202564
Fax
917940202021
Email
sheejith@lambda-cro.com
Details of Contact Person Scientific Query
Name
Dr Randhirsingh Solanki
Designation
Assistant General Manager
Affiliation
Lambda Therapeutic Research Ltd.
Address
Lambda Therapeutic Research Ltd.
Plot No. 38, Near Silver Oak Club, S. G. Highway, Gota,
Ahmedabad – 380 061,
Gujarat,
India NIL Ahmadabad GUJARAT 380 061 India
Phone
917940202070
Fax
917940202021
Email
randhirsinh@lambda-cro.com
Details of Contact Person Public Query
Name
Dr Randhirsingh Solanki
Designation
Assistant General Manager
Affiliation
Lambda Therapeutic Research Ltd.
Address
Lambda Therapeutic Research Ltd.
Plot No. 38, Near Silver Oak Club, S. G. Highway, Gota,
Ahmedabad – 380 061,
Gujarat,
India NIL Ahmadabad GUJARAT 380 061 India
Phone
917940202070
Fax
917940202021
Email
randhirsinh@lambda-cro.com
Source of Monetary or Material Support
Accord Healthcare Ltd.Ground Floor, Sage House, 319, Pinner Road,
North Harrow, Middlesex, HA1 4HF,
United Kingdom.
Primary Sponsor
Name
Accord Healthcare Ltd
Address
Ground Floor, Sage House, 319, Pinner Road,
North Harrow, Middlesex, HA1 4HF,
United Kingdom.
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India Poland
Sites of Study
No of Sites = 9
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
DrKalpesh Shah
Institute of cosmetic and skin care
7-J,8th Floor, "Sumeru", Near Parimal Under bridge, Paldi, Ahmedabad-380007 Ahmadabad GUJARAT
Placebo Comparator: Vehicle (the ointment base) from Accord Healthcare Ltd., UK
Treatment applied as a thin layer to all affected areas (1 cm ribbon spread is recommended over approx. 100 cm2 skin surface) twice daily for 6 weeks (End of Treatment)
Applied as a thin layer to all affected areas (1 cm ribbon spread is recommended over approx. 100 cm2 skin surface) twice daily for 6 weeks (End of Treatment)
Intervention
Tacrolimus Monohydrate Ointment 0.1%
Applied as a thin layer to all affected areas (1 cm ribbon spread is recommended over approx. 100 cm2 skin surface) twice daily for 6 weeks (End of Treatment).
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 for AD, or when those treatments are not advisable in the opinion of the Investigator.
5. Last application of medicated topical agents, intake of systemic antihistamines, intranasal or inhaled corticosteroids (> 1 mg/day) should be minimum 7 days prior to randomization.
6. Last application of tacrolimus ointment, intake of systemic corticosteroids and nonsteroidal immunosuppressants should be minimum 3 weeks prior to randomization.
ExclusionCriteria
Details
1. Newly diagnosed or Treatment naïve patients
2. Patients with mild (Rajka and Langeland score of < 4.5) or very severe atopic dermatitis that requires systemic therapy
1. Patients in need of undergoing UV treatments for AD.
2. Clinically infected atopic dermatitis at the baseline visit
Method of Generating Random Sequence
Other
Method of Concealment
Other
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
Change from baseline in Eczema Area and Severity Index (EASI) score
Day 0, Day 4. day 7, day 14, day 21, Day 28, day 28, day 42 and day 56
Secondary Outcome
Outcome
TimePoints
1. Percentage of patients with ≥ 60% improvement on EASI total score
Week 6 / End of Treatment (EOT) Visit
2. Change in grading of AD as defined by the scoring system of Rajka and Langeland from baseline
at Week 6 / End of Treatment (EOT) Visit
3. Percentage of body surface area affected (% BSA affected)
Week 6 / End of Treatment (EOT) Visit
4.Physician’s Assessment of Individual Signs of Atopic Dermatitis
Week 6 / End of Treatment (EOT) Visit
5.Patient’s Assessment of Pruritus
week 6/ End of Treatment (EOT)
Target Sample Size
Total Sample Size="650" Sample Size from India="455" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
A Randomized, Double-Blind, Placebo-controlled,
Three-arm, Parallel Assignment,
Multi-centre, Therapeutic Equivalence Study of Two Tacrolimus 0.1% Topical Ointment Formulations in Adult Patients
with Moderate to Severe Atopic Dermatitis
Atopic dermatitis (AD) is an inflammatory skin
disease with a chronically relapsing course and is characterized by episodes of
intense pruritus, lichenification, severely dry skin, and a susceptibility to
cutaneous infections. [1-4] Atopic dermatitis impacts the quality of
life (QOL) of patients physically (itch, pain), psychologically (such as
hindrance of social interaction, low self-esteem, and sleep disturbance) and
financially.
AD, a common skin disease that occurs in persons of
all ages, whose prevalence worldwide has
increased 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. Topical corticosteroids have long been the first-line treatment
for AD. Although the efficacy of topical corticosteroids in controlling acute
symptoms of AD is well established in the short term with good tolerability in
general, potential side effects limit their use in the long-term.
Inclusion criteria
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).
Non-immunocompromised adults who have failed to
respond adequately to other topical prescription treatments for AD, or when
those treatments are not advisable in the opinion of the Investigator
Exclusion criteria
1.Newly diagnosed or Treatment naïve patients.
2.Patients with mild (Rajka and Langeland score of <
4.5) or very severe atopic dermatitis that requires systemic therapy.
3.Patients in need of undergoing UV treatments for AD.
4.Clinically infected atopic dermatitis at the baseline
visit.
5.Any
deermatological condition other than atopic dermatitis as
scar/wound/tattoo at the application site or in its close vicinity that in the Investigator’s
opinion may interfere with the evaluation of the patient’s atopic dermatitis