| CTRI Number |
CTRI/2016/03/006782 [Registered on: 31/03/2016] Trial Registered Retrospectively |
| Last Modified On: |
23/03/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceutical] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
MetaDerm Cream in Atopic Dermatitis |
|
Scientific Title of Study
|
Efficacy and Tolerability of MetaDerm in Subjects with
Moderate to Severe Atopic Dermatitis |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MSCR/HCTP/2015-01 Version 1.0, dated 15 Feb 2016 |
Protocol Number |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mukta Sachdev |
| Designation |
Principal Investigtor |
| Affiliation |
MS Clinical Research |
| Address |
Dermatology Evaluation room,
1st Floor
MS Clinical Research (P) Ltd
327/15, 1st Main Road, Cambridge Layout,
Ulsoor
Bangalore
Bangalore
KARNATAKA
560008
India |
| Phone |
08040917253 |
| Fax |
08041125934 |
| Email |
mukta.sachdev@mscr.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukta Sachdev |
| Designation |
Principal Investigtor |
| Affiliation |
MS Clinical Research |
| Address |
Dermatology Evaluation room,
1st Floor
MS Clinical Research (P) Ltd
327/15, 1st Main Road, Cambridge Layout,
Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
08040917253 |
| Fax |
08041125934 |
| Email |
mukta.sachdev@mscr.in |
|
Details of Contact Person
Public Query
|
| Name |
Ritambhara |
| Designation |
Manager |
| Affiliation |
MS Clinical Research |
| Address |
Ground Floor,
MS Clinical Research (P) Ltd
327/15, 1st Main Road, Cambridge Layout,
Ulsoor
Bangalore
Bangalore
KARNATAKA
560008
India |
| Phone |
9945952952 |
| Fax |
08041125934 |
| Email |
ritambhara@mscr.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Haus Bioceuticals Inc |
| Address |
744 Research Pkwy, #460, Oklahoma City, OK
|
| Type of Sponsor |
Other [Evidence based Medicine- Research and Developement] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mukta Sachdev |
MS Clinical Research |
327/15, 1st Main Road, Cambridge Layout,
Ulsoor, Bangalore, India
Bangalore
KARNATAKA |
08040917253
08041125934
mukta.sachdev@mscr.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Lifeline Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
moderate to severe Atopic Dermatitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MetaDerm Cream |
Twice daily topical application on lesion and adjacent non -lesion area for a period of 3 months. The quantity of product application will vary based on the size of lesion. |
| Comparator Agent |
Vehicle cream |
Twice daily topical application on lesion and adjacent non-lesion area for a period of 3 months. Quantity of each application will vary based on the size of lesion. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
• Moderate to severe atopic dermatitis as determined by Physician’s Global Assessment (PGA > 3.
• Males and females, age 12 - 65 years old inclusive.
|
|
| ExclusionCriteria |
| Details |
• Is currently participating or has participated in another interventional clinical study at this or any other facility in the past 2 weeks.
• Currently or has been diagnosed or treated for cancer in the past 5 years.
• Requires any topical or systemic medications that could affect the course of their atopic dermatitis during the study period (except inhaled steroids and/or stable antihistamines for asthma or allergies).
• Has a known hypersensitivity to any corticosteroid creams.
• Has any active infections or has used antibiotics in the past 7 days.
• Has any physical attributes or skin conditions that might interfere with the clear visual or instrumental assessments.(i.e. cuts, sunburn, birth marks, tattoos, extensive scarring,excessive hair growth or acne).
• Has an immunologic or infectious disease (e.g. hepatitis, tuberculosis, HIV or AIDS, lupus rheumatoid arthritis) which could place the subject at risk or interfere with the accuracy of the study results.
• Has used any immunosuppressant drugs or immunotherapy within the past 30 days or 5 half-lives.
• Is an employee of the sponsor company or clinical testing site.
• Is dependent on oral medication for any skin disease/condition or could not, in the opinion of the Investigator tolerate the restriction of discontinuing the medicine as required in this study.
• Is currently pregnant or lactating or planning to become pregnant in the next 6 months (using double contraception for prevention).
• Has a history of keloid formation following skin injury.
• Is routinely taking anti-coagulant medications (i.e. Plavix,Coumadin, warfarin, heparin, etc.)
• Any other condition or factor the Investigator or their duly assigned representative believes may affect the ability of the subject to complete the study or the interpretation of the results.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary endpoint is: Change in Scoring of Atopic Dermatitis (SCORAD) score.
|
[Time Frame: Baseline to week 12] |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Absolute change in Eczema Area and Severity Index (EASI) score.
Proportion of patients achieving a Physician’s Global Assessment
(PGA) score of 0 or 1
Incidence of treatment emergent AE’s |
[Time Frame: Baseline to week
12] |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2016 |
| 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="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Atopic dermatitis (AD) is a chronic inflammatory
skin disease characterized by a disturbance of epidermal-barrier function that
results in intensely pruritic subacute and chronic eczematous plaques. As the
most common cause of chronic inflammatory skin diseases, AD is a major cause of
morbidity and suffering, affecting upto 30% of children, and increasing in
prevalence throughout the world. The current
therapy of AD is reactive, where the flares are treated through symptomatic
management with topical corticosteroids and calcineurin inhibitors. Given that
these medications have long-term side-effects, and given the chronically
relapsing immunopathogenic nature of AD, there is an imperative need for safer
anti-inflammatory medications. Haus Bioceuticals has developed a topical
treatment for eczema/atopic dermatitis (AD) denoted MetaDerm, and have
demonstrated that MetaDerm is safe and profoundly effective in the treatment of
AD, controlling signs and symptoms in 85% of patients with AD. MetaDerm was characterized to have unique immunosuppressive profiles identified to be TLR, MAPK and NFkB- modulated, implying distinct anti-inflammatory and immunomodulatory modes of action. Safety study demonstrated that MetaDerm was characterized as non-toxic and non-irritant as per OECD guidelines, and did not demonstrate any cytotoxicity to various non-inflammatory cells tested, including fibroblast and epithelial cells. MetaDerm has the potential to have significant therapeutic and clinical impact and address a significant unmet need for a safe and effective topical therapy in patients with AD.
Total Duration : 17 weeks Wash out : 01 Week Treatment period: 12 weeks Recurrence : 4 weeks |