| CTRI Number |
CTRI/2016/05/006927 [Registered on: 12/05/2016] Trial Registered Retrospectively |
| Last Modified On: |
20/06/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Human Repeated Insult Patch test] |
| Study Design |
Other |
|
Public Title of Study
|
Skin sensitivity test to evaluate the safety of test products. |
|
Scientific Title of Study
|
Human Repeat Insult Patch Test to evaluate the dermatological safety of test products of Haus Bioceuticals |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MSCR/HCHR/2016-03, Vesrison 1.0 dated 05 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
327/15, 1st Main Road, Cambridge Layout, Ulsoor, Bangalore, India
Bangalore
KARNATAKA
560008
India |
| Phone |
918040917253 |
| Fax |
918041125934 |
| 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
327/15, 1st Main Road, Cambridge Layout, Ulsoor, Bangalore, India
Bangalore
KARNATAKA
560008
India |
| Phone |
918040917253 |
| Fax |
918041125934 |
| Email |
mukta.sachdev@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mukta Sachdev |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research |
| Address |
327/15, 1st Main Road, Cambridge Layout, Ulsoor, Bangalore, India
327/15, 1st Main Road, Cambridge Layout, Ulsoor, Bangalore, India
Bangalore
KARNATAKA
560008
India |
| Phone |
918040917253 |
| Fax |
918041125934 |
| Email |
mukta.sachdev@gmail.com |
|
|
Source of Monetary or Material Support
|
| Study Sponsor: Haus Bioceuticals, Inc.
744 Research Pkwy, Suite 460 Oklahoma City, OK 73104 |
|
Primary Sponsor
Modification(s)
|
| Name |
Haus Bioceuticals Inc |
| Address |
Inc. 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 Mukta Sachdev |
MS Clinical Research |
2nd floor, Sensitivity room, 327/15, 1st Main Road, Cambridge Layout, Ulsoor, Bangalore, India
Bangalore
KARNATAKA |
918040917253
918041125934
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
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal, Atopic dermatitis and psoriasis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| 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
|
20 microliters of investigational product (Without dilution) will be loaded in the finn chamber and applied on the back of subjects.
40 microliters of the investigational product (with dilution as per the protocol)will be loaded in the finn chamber and will be applied on the back of subjects.
Frequency: Every 48 hr patch application for first three weeks,Two weeks rest phase and 1 patch application in the last week of the study.
Route of Administration: Topical Application
Total Duration of therapy- Approximately 6 weeks for each subject. |
| Comparator Agent |
None |
None |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
In order to be eligible for participation, subjects must be:
1.males or females 18 years of age or older – no more than 20% of the panel should be comprised of subjects over the age of 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
|
|
| ExclusionCriteria |
| Details |
Subjects are not eligible for participation if any one of the following applies:
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 pigmentation, extensive scarring, or pigmented lesions in the patch areas, which could interfere with the scoring
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 using on a routine or frequent basis antihistamines or any systemic or topical anti-inflammatory medications (e.g. ibuprofen, corticosteroid, etc.). 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 or Designate, 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
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the dermatological safety of test product by human repeated insult patch test |
Approximately 6 weeks for each subjects |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
|
Target Sample Size
|
Total Sample Size="116"
Sample Size from India="116"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/04/2016 |
| 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="2"
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
Modification(s)
|
Study Objective:The purpose of this study is to confirm that the test substances will not produce evidence of delayed contact sensitization following external contact with the skin by means of a repeated patch application procedure.
- n2 = 06 subjects diagnosed with atopic dermatitis
- n3 = 10 subjects diagnosed with plaque psoriasisDuring Induction phase- 3 weeks
All the test products will be applied every alternate day for three weeks for a total of 9 patch applications. Each application will be for 48 hours under occlusion (complete or semi based on product type). Evaluation of irritation will be done before application of succeeding patch.
During challenge phase, the patches will be applied to the original site (initial induction site) and, a similar untested/naïve site, preferable on the opposite side of the body (alternate site). Patches are worn for 48 hours (± 1 hour), then removed at the site and discarded. Readings are taken at 48, 72 and 96 hrs after removal
|