| CTRI Number |
CTRI/2018/02/012017 [Registered on: 20/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
19/02/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Human Phototoxicity Skin Patch Test ] |
| Study Design |
Other |
|
Public Title of Study
|
Skin Patch Test to study Human Phototoxicity. |
|
Scientific Title of Study
|
Human Phototoxicity Skin Patch Test to evaluate the dermatological safety of test products of Haus Bioceuticals |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MSCR/HCTP/2016-04,Version 1.0,dated 18 May 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,Groud Floor, 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
327/15,Ground floor,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
Public Query
|
| Name |
Ritambhara |
| Designation |
Manager |
| Affiliation |
MS Clinical Research |
| Address |
Ground Floor, 327/15, 1st Main Road, Cambridge Layout, Ulsoor, Bangalore, India
Room No 2,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
|
| Study Sponsor: Haus Bioceuticals, Inc. 744 Research Pkwy, Suite 460 Oklahoma City, OK 73104 |
|
|
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 |
080-40917253
080-41125934
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 |
| 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:Once for each subject |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Males or females, 18 to 65 years of age. A representative distribution within this age span is desirable.
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 |
1.Have a clinical diagnosis of a dermatological condition other that atopic dermatitis or psoriasis (such as contact dermatitis, cutaneous lymphoma, tineacorporis, 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 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 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.
19.Use or are expecting to use during the study any of (but not limited to) the following: sulfa drugs, tetracyclines, phenothiazines, tranquilizers or antiemetics (e.g. Chlorpromazine, Thorazine, Phenergan), Diurel, Hydroduril, Biabinese or tar containing shampoos ( e.g. Sebritone, Tegrin, etc.) or any other medication bearing a warning to avoid sunlight.
20.Have a history of severe reactions to sun exposure, incuding phototoxicity/photoallergy, solar urticaria, polymorphous light eruption or other photoaggravated disease.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To confirm that a test substance will not produce evidence of skin phototoxicity following topical contact with the skin by means of a single application patch test. |
Total 6 Visits for each subject and approximately 2 weeks for each subject |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
|
Target Sample Size
|
Total Sample Size="41"
Sample Size from India="41"
Final Enrollment numbers achieved (Total)= "42"
Final Enrollment numbers achieved (India)="39" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2016 |
| Date of Study Completion (India) |
11/06/2016 |
| Date of First Enrollment (Global) |
01/06/2016 |
| Date of Study Completion (Global) |
11/06/2016 |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None Yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Study Objective: The purpose of this study is to
confirm that a test substance will not produce evidence of skin phototoxicity
following topical contact with the skin by means of a single application patch
test.
Study Duration: Approximately 2 weeks for each subject.
Study Population: Total 41 subjects ( 25 normal healthy subjects, 06 subjects with atopic dermatitis and 10 subjects with active plaque psoriasis).
Methodology: Each test substance will be applied to 2
identical contralateral patches. These
patches will be applied to selected sites on the lower or middle back of each
test subject. Reinforcing tape (e.g.
Scanpore®, Micropore®, etc.) can be used to secure the
patch, as necessary. For each test
substance, one site will be irradiated and one site will be a
non-irradiated control site. The
subjects will leave the patches in place and dry for 24 hours (±1 hour). These applications will be documented on the
Topical Treatment, Irradiation and Scoring form After 24 hours (±1 hour), the patches will be
removed and discarded by test facility personnel. Skin sites will be wiped with a dry gauze to
remove any excess test substance. After
completion of 24 hours of occlusion, both patch systems will be taken off. 30
minutes post removal of the patch dermatological assessment of the sites
(including controls) will be done following which one of the two sites and untreated
irradiated control site (randomized and investigator blinded) will be
irradiated with 0.5 MED. 10 minutes
post irradiation another reading will be taken by the
dermatologist/investigator.Subsequent readings will be taken at 24 and 48 hours post irradiation. |