| CTRI Number |
CTRI/2017/06/008950 [Registered on: 30/06/2017] Trial Registered Retrospectively |
| Last Modified On: |
30/06/2017 |
| 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
|
To evaluate the effectiveness of MetaDerm Cream in Atopic Dermatitis |
|
Scientific Title of Study
|
A Study to Evaluate the Efficacy and Safety of Metaderm M1 and Metaderm M5 Cream Formulas in Patients with Moderate to Severe Atopic Dermatitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MSCR/HCAD/2017-01, Version 1.0 dated 01 May 2017 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rachana Shilpakar |
| Designation |
Principal Investigator |
| Affiliation |
MS clinical Research Pvt Ltd |
| Address |
Dermatology Evaluation Room, 1st Floor, 327/15, 1st main road,
Cambridge Layout, Ulsoor, Bangalore-560008
India
Bangalore
KARNATAKA
560008
India |
| Phone |
08040917253 |
| Fax |
08041125934 |
| Email |
rachana.shilpakar@mscr.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rachana Shilpakar |
| Designation |
Principal Investigator |
| Affiliation |
MS clinical Research Pvt Ltd |
| Address |
Dermatology Evaluation Room, 1st Floor, 327/15, 1st main road,
Cambridge Layout, Ulsoor, Bangalore-560008
India
KARNATAKA
560008
India |
| Phone |
08040917253 |
| Fax |
08041125934 |
| Email |
rachana.shilpakar@mscr.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rachana Shilpakar |
| Designation |
Principal Investigator |
| Affiliation |
MS clinical Research Pvt Ltd |
| Address |
Dermatology Evaluation Room, 1st Floor, 327/15, 1st main road,
Cambridge Layout, Ulsoor, Bangalore-560008
India
KARNATAKA
560008
India |
| Phone |
08040917253 |
| Fax |
08041125934 |
| Email |
rachana.shilpakar@mscr.in |
|
|
Source of Monetary or Material Support
|
| Haus Bioceuticals, Inc.744 Research Pkwy, Suite 460 Oklahoma City, OK 73104 |
|
|
Primary Sponsor
|
| Name |
Haus Bioceuticals Inc |
| Address |
744 Research Pkwy, Suite 460 Oklahoma City, OK 73104 |
| Type of Sponsor |
Other [Evidence Based Medicine-Research and Development] |
|
|
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 Rachana Shilpakar |
MS Clinical Research Pvt Ltd |
Dermatological
evaluation room, first
floor, 327/15, 1st Main
Road Cambridge
Layout, Ulsoor
Bangalore, India
Bangalore
KARNATAKA |
08040917253
08041125934
rachana.shilpakar@mscr.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Clinicom 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 |
1)Metaderm M1 Cream
2)Metaderm M5 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. The quantity of product 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 |
1) Moderate to severe atopic dermatitis as determined by Physician’s Global Assessment (PGA > 3) and SCORAD > 25 (SCORAD and PGA will incorporate whole body assessments)
2)Males and females, age 12 - 65 years old inclusive
|
|
| ExclusionCriteria |
| Details |
1) Is currently participating or has participated in another interventional clinical study at this or any other facility in the past 3 months.
2) Currently or has been diagnosed/treated for cancer in the past 5 years.
3) Requires any topical or systemic medications that could affect the course of their atopic dermatitis during the study period (except inhaled steroids and/or antihistamines for asthma or allergies).
4) Has a known hypersensitivity to any corticosteroid creams.
5) Has any active infections or has used antibiotics in the past 7 days.
6) 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)
7) 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.
8)Has used any immunosuppressant drugs or immunotherapy within the past 30 days or 5 half-lives.
9) Is an employee of the sponsor company or clinical testing site.
10) 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.
11)Is currently pregnant or lactating or planning to become pregnant in the next 6 months (using double contraception for prevention).
12)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 |
| Change in Scoring of Atopic Dermatitis (SCORAD) score. [Time Frame: baseline to week 12] |
12 Weeks for each subject |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Proportion of patients achieving a Physician’s Global Assessment
(PGA) score of 0 or 1 [Time Frame: baseline to week 12]
Incidence of treatment emergent AE [Time Frame: baseline to week 12]
|
12 Weeks for each subject |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
01/06/2017 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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 (Haus) 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. This study is
aimed to further evaluate the therapeutic potential of a new MetaDerm cream in
AD. Total Study Duration: 13 Weeks
for each subject Wash out Period: 1 week
Treatment Period: 1 week |