| CTRI Number |
CTRI/2013/01/003275 [Registered on: 01/01/2013] Trial Registered Prospectively |
| Last Modified On: |
27/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To evaluate in Human volunteers bioequivalence of Motyvate Cream with Reference Listed Drug Elocon Cream , by comparison of vaso constriction caused. |
|
Scientific Title of Study
|
Evaluation of in-vivo bioequivalence, by comparison of vaso constriction caused by Test Product Motyvate Cream with Reference Listed Drug Elocon Cream |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CL/026/1112/STU ; 1 of 21st November 2012 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrRajiv Joshi |
| Designation |
Principal Investigator |
| Affiliation |
C.L.A.I.M.S. Pvt. Ltd. |
| Address |
C.L.A.I.M.S. PVT.LTD
4th floor, B wing,
Modi House,
C-10, Dalia Industrial Estate,
New Link Road,
Andheri (W),
Mumbai
MAHARASHTRA
400058
India |
| Phone |
66758851 |
| Fax |
66758854 |
| Email |
rsjdr@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRajiv Joshi |
| Designation |
Principal Investigator |
| Affiliation |
C.L.A.I.M.S. Pvt. Ltd. |
| Address |
C.L.A.I.M.S. PVT.LTD
4th floor, B wing,
Modi House,
C-10, Dalia Industrial Estate,
New Link Road,
Andheri (W),
Mumbai
MAHARASHTRA
400058
India |
| Phone |
66758851 |
| Fax |
66758854 |
| Email |
rsjdr@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr CN Narayanan |
| Designation |
Dy.GM (R&D) |
| Affiliation |
Apex Laboratories Pvt. Ltd. |
| Address |
Apex Laboratories Pvt. Ltd. SIDCO Garment Complex, III Floor, Guindy, Chennai, Tamil Nadu India
Chennai
TAMIL NADU
600032
India
Chennai
TAMIL NADU
600032
India |
| Phone |
4442225000 |
| Fax |
4442225005 |
| Email |
cnn@apexlab.com |
|
|
Source of Monetary or Material Support
|
| Apex Laboratories Pvt. Ltd Apex Laboratories Pvt. Ltd.SIDCO Garment Complex, III Floor, Guindy, Chennai, Tamil Nadu - 600 032 |
|
|
Primary Sponsor
|
| Name |
Apex Laboratories Pvt Ltd |
| Address |
Apex Laboratories Pvt Ltd.
SIDCO Garment Complex, III Floor, Guindy, Chennai, Tamil Nadu - 600 032 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Rajiv Joshi |
C.L.A.I.M.S. PVT.LTD |
4th floor, B wing,
Modi House,
C-10, Dalia Industrial Estate,
New Link Road,
Andheri (W), Mumbai-400058
Mumbai
MAHARASHTRA |
66758851
66758854
rsjdr@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee, Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Should be responders to the drug (have demonstrated blanching response) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Elocon Cream |
Mometasone Furoate IP 0.1% w/w
Topical application on marked test sites. Dose duration: 70 mins, 140 mins and 280 mins. |
| Intervention |
Motyvate Cream |
Mometasone Furoate USP 0.1% w/w
Route of application: Topical application on marked test sites. Dose duration: 70 mins, 140 mins and 280 mins. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects should be responders to the drug (have demonstrated blanching response to RLD- Elocon Cream)
2. Phototype III and IV.
3. Age: 18-45 years.
4. Has been fully informed and willing to sign Informed Consent Document.
5. Non-tobacco-using subjects.
6.Presenting normal healthy skin type
7.Cooperating, informed of the need and duration of the examinations.
8. For which the investigator considers that the compliance will be correct.
9.Healthy Subjects (Healthy/ Good health as demonstrated by lack of clinically significant abnormalities in medical history and clinical assessment, as judged by the investigator).
|
|
| ExclusionCriteria |
| Details |
1. Clinically significant hypertension or circulatory disease.
2. Chronic illness which may influence the skin sensitivity.
3. History of allergy to any cosmetic product/ topical application.
4. Subject in an exclusion period or participating in another cosmetic or therapeutic trial.
5. Presence of any skin condition or pigmentation that would interfere with the placement of test sites or the response or assessment of skin blanching.
6. Subjects on any medical treatment either systemic or topical presently or in the past 1 month).
7. Drug or alcohol addiction requiring treatment (in-patient or out-patient) in the 12 months prior to dosing.
8. Persons who would require shaving ventral forearms to ensure consistent dose on skin surface.
9. Use of any vasoactive (constrictor or dilator) medication prescription or OTC, that could modulate blood flow.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of Vaso-constriction property of products using Spectrophotometer (‘a’ scale readings), which will help determine AUEC values needed for the comparison of the products for In-vivo Bioequivalence Study. |
Evaluation of Vaso-constriction property of products using Spectrophotometer (‘a’ scale readings), which will help determine AUEC values needed for the comparison of the products for In-vivo Bioequivalence Study. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/01/2013 |
| Date of Study Completion (India) |
22/02/2013 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Screening for Responders
- Demographic
information (age, date of birth etc.)
- Medical
history (any illness-presently or in past)
- Prior
treatments (medication)
- Clinical
examination and evaluation of the test area (examination by doctor)
- Explanation
of the Trial and procedures
- Handing
out the Informed consent document
- Collecting
& documenting informed consent
- Clinical
evaluation of test site
- Concomitant
treatments
- Application
of the reference product to any 2 sites other than the inner forearm for
checking of Responder status.
- Removal
of product, 6 hrs after product
application by gently dabbing a cotton swab.
- Clinical
evaluation of site for Response 2
hrs after product removal
- If
found a Responder, consider for study.
D0: H0
·
Acclimatize volunteers under controlled
conditions for 2 hours.
·
Marking of 8 test sites on each forearm.
·
The baseline reading using a Spectrophotometer at all marked sites.
D0: Product
Application
·
Application of approximately 7 mg/cm2
the Reference listed product (quantity depending on patch size and potency of
drug) on 6 patches on each forearm randomly.
·
All sites will be kept non occluded after
application.
·
2 sites on each forearm kept untreated as
control sites.
D0: Post Product
Application
·
Leave product non
occluded on patches marked TP (test) and
RLD (reference) for dose duration equal to ED50, D1 and D2 as pre decided.
·
Spectrophotometric
evaluations at pre-dose (baseline) and at 0, 2, 4, 6, 19 and 24 hours after
product removal.
|