| CTRI Number |
CTRI/2017/05/008636 [Registered on: 23/05/2017] Trial Registered Retrospectively |
| Last Modified On: |
15/05/2017 |
| 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 HAT01H Cream in Atopic Dermatitis. |
|
Scientific Title of Study
|
Efficacy and Tolerability of New MetaDerm Cream (HAT01-H) in
Subjects with Moderate to Severe Atopic Dermatitis
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MSCR/HCAD/2016-05, version 1.0 dated 28 Feb 2017 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mukta Sachdev |
| 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
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 Investigator |
| Affiliation |
MS Clinical Research Pvt Ltd |
| Address |
Dermatology Evaluation Room, 1st Floor, 327/15, 1st main road, Cambridge Layout, Ulsoor, Bangalore-560008
Bangalore
KARNATAKA
560008
India |
| Phone |
08040917253 |
| Fax |
08041125934 |
| Email |
mukta.sachdev@mscr.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mukta Sachdev |
| 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
Bangalore
KARNATAKA
560008
India |
| Phone |
08040917253 |
| Fax |
08041125934 |
| Email |
mukta.sachdev@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 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 Pvt Ltd |
Dermatological evaluation room, first floor, 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 |
| 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 |
HAT01H 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 |
HAT01H 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 |
The primary endpoint is:
Change in Scoring of Atopic Dermatitis (SCORAD) score.
[Time Frame: baseline to week 12]
|
12 Weeks for each subject |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of treatment emergent AE [Time Frame: baseline to week 12] |
12 Weeks for each subject |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/03/2017 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 denoted MetaDerm HAT01H, and have demonstrated that MetaDerm HAT01H is safe and profoundly effective in the treatment of AD. This study is aimed to further evaluate the therapeutic potential of a MetaDerm HAT01H cream in AD. Total Study Duration: 13 Weeks for each subject Wash out Period: 1 week Treatment Period: 1 week |