| CTRI Number |
CTRI/2016/06/006992 [Registered on: 03/06/2016] Trial Registered Retrospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cumulative Irritation Patch Test] |
| Study Design |
Other |
|
Public Title of Study
|
Cumulative irritation test (14 Day) |
|
Scientific Title of Study
|
Human Cumulative Irritation Patch Test to evaluate the dermatological safety of test products of Haus Bioceuticals |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MSCR/HCCT/2016-02, version 1.0 dated 15 Apr 2016 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mukta Sachdev |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research |
| Address |
327/15, 1st Main Road, Cambridge Layout, Ulsoor, Bangalore, India
Bangalore
KARNATAKA
560008
India |
| Phone |
080-40917253 |
| Fax |
080-41125934 |
| Email |
mukta.sachdev@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukta Sachdev |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research |
| Address |
327/15, 1st Main Road, Cambridge Layout, Ulsoor, Bangalore, India
KARNATAKA
560008
India |
| Phone |
080-40917253 |
| Fax |
080-41125934 |
| Email |
mukta.sachdev@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ritambhara |
| Designation |
Manager |
| Affiliation |
MS Clinical Research |
| Address |
Ground Floor,
327/15, 1st Main Road, Cambridge Layout, Ulsoor, Bangalore, India
Bangalore
KARNATAKA
560008
India |
| Phone |
9945952952 |
| Fax |
080-41125934 |
| Email |
ritambhara@mscr.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Haus Bioceuticals Inc |
| Address |
744 Research Pkwy, #460, Oklahoma City, OK USA |
| 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 |
Skin sensitivity room, second floor, MS Clinical Research Pvt. Ltd.
327/15, 1st Main Road, Cambridge Layout, Ulsoor, Bangalore, India
Bangalore
KARNATAKA |
08040917253
08041125934
mukta.sachdev@gmail.com |
|
|
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 |
| Healthy Human Volunteers |
Healthy subjects |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
1% SLS- Positive control
Normal Saline- Negative control |
the controls will be patched along with all test products.
Dose:1% SLS- 20 microlitere
Normal Saline-20 Microlitere
Route of administration: Topical Application
Frequency: continuous 14 days patch application for each subject
Duration of the therapy: Approximately 15 days for each subject.
|
| Intervention |
1)HB Cream EPBF2
2)HB Cream HMF3
3)HB Body Wash EPB3
4)HB Cream PT1
5)HB Cream HMT1
6)HB Cream EBT1 |
HB Body Wash EPB3 will be semi occluded, other test products will be patched under complete occlusion.
Dose:20 microliter (Without dilution) and 40 microliter (With dilution) as per the protocol.
Route of administration: Topical Application
Frequency: continuous 14 days patch application for each subject
Duration of the therapy: Approximately 15 days for each subject.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.males or females between the ages of 18 and 65
2.in general good health as determined by the Medical and Dermatological History Questionnaire (Appendix A) or as having diagnosed with atopic dermatitis or active plaque psoriasis confirmed by a dermatologist
3.Able to read, understand and sign an informed consent agreement after being advised of the nature of the study
4.Willing to refrain from using lotions, creams, powders or other skin preparations on the skin in the test area for the duration of the study
5.Willing to refrain from exposing skin sites to the sun or going to tanning beds for the duration of the study
6.Willing to refrain from swimming and using hot tubs for the duration of the study
|
|
| ExclusionCriteria |
| Details |
1.have a clinical diagnosis of a dermatological condition other that atopic dermatitis or psoriasis (such as contact dermatitis, cutaneous lymphoma, tinea corporis, etc.), or have nonplaque forms of psoriasis (for example, erythrodermic, guttate, or pustular), or have bacterial infections of the skin, including impetigo or abscesses.
2.have a history of skin cancer or have received treatment (chemotherapy, radiation, immune suppressant medications) for any type of cancer within the last 6 months
3.have a condition or are taking medication(s) which, in the judgment of the Investigator or Designate, makes the subject ineligible or places the subject at undue risk
4.have received treatment (chemotherapy, radiation, immune suppressant medications) for any type of cancer within the last 6 months
5.have had a mastectomy or axillary lymph nodes removed
6.have an autoimmune or immune deficiency disease (e.g. lupus, myositis, Crohns disease, autoimmune thyroid diseases, autoimmune hepatitis, etc.)
7.are currently taking any immunosuppressant medication
8.have insulin-dependent diabetes
9.have asthma or any other chronic respiratory condition requiring daily therapy
10.are currently taking/using any antihistamines or systemic/topical anti-inflammatory medications (e.g. ibuprofen, corticosteroid, etc.) on a routine or frequent basis. Maximum acceptable dosage should be determined by written laboratory guidelines.
11.have used a topical anti-inflammatory in the patch area within the last 2 weeks
12.are currently receiving allergy injections, expects to start injections before the conclusion of the study or has had the final injection within a week of the study start
13.are currently participating in another dermal study of any kind
14.are currently participating in any clinical study, which in the judgment of the Investigator, could potentially affect responses in either study.
15.have a confirmed skin allergy as a result of participation in a patch study
16.have a known sensitivity or allergy relating to the substance(s) being evaluated
17.have a known sensitivity or allergy to adhesives, surgical tapes, bandages, etc.
18.have scars, moles, sunburn, tattoos, etc. in the patch area
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the potential of test substances to elicit human skin irritation by repetitive topical application. |
Approximately 15 days for each subject. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
09/05/2016 |
| 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="1"
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
|
Study Objective:
To assess the potential of test substances to elicit human skin irritation by repetitive topical application.
Study Duration: Approximately 15 days for each subject.
Study Population: Total 46 subjects ( 30 normal healthy subjects, 06 subjects with atopic dermatitis and 10 subjects with active plaque psoriasis.
Methodology: Patch applications under complete or semi occlusion are made on consecutive days (including Saturday and Sunday) for 14 days for each product. A final grade is taken 24 hours following the last patch application. |