| CTRI Number |
CTRI/2012/08/002893 [Registered on: 16/08/2012] 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 Clobetz Cream (Clobetasol propionate USP 0.05% w/w)with Reference Listed Drug Tenovate Cream (Clobetasol propionate BP 0.05% w/w) , by comparison of vaso constriction caused. |
|
Scientific Title of Study
|
Evaluation of in-vivo bioequivalence, by comparison of vaso constriction caused by Test Product Clobetz Cream with Reference Listed Drug Tenovate Cream |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CL/011/0712/STU |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajiv 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 Ind 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 |
Dr Rajiv 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 Ind 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 |
| 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 |
| Address |
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
MAHARASHTRA
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)
Phototype III and IV. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Clobetz Cream |
Clobetasol propionate USP 0.05% w/w
Route of application: Topical application on marked test sites. Dose duration: 30 mins |
| Comparator Agent |
Tenovate Cream |
Clobetasol propionate BP 0.05% w/w
Route of application: Topical application on marked test sites.
Dose duration: 15 mins, 30 mins and 60 mins. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
- Subjects should be responders to the drug (have demonstrated blanching response to RLD- Tenovate Cream )
- Phototype III and IV.
- Age: 18-45 years.
- Has been fully informed and willing to sign Informed Consent Document.
- Non-tobacco-using subjects.
- Presenting normal healthy skin type
- Cooperating, informed of the need and duration of the examinations.
- For which the investigator considers that the compliance will be correct.
- 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 |
- Clinically significant hypertension or circulatory disease.
- Chronic illness which may influence the skin sensitivity.
- History of allergy to any cosmetic product/ topical application.
- Subject in an exclusion period or participating in another cosmetic or therapeutic trial.
- Presence of any skin condition or pigmentation that would interfere with the placement of test sites or the response or assessment of skin blanching.
- Subjects on any medical treatment either systemic or topical presently or in the past 1 month).
- Drug or alcohol addiction requiring treatment (in-patient or out-patient) in the 12 months prior to dosing.
- Persons who would require shaving ventral forearms to ensure consistent dose on skin surface.
- Pregnant as confirmed by UPT or lactating women.
- Consumption on average of more than 6 cups (500 mg caffeine) of caffeine containing beverages daily.
- Any obvious difference in skin color between arms.
- 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)
|
20/08/2012 |
| Date of Study Completion (India) |
26/09/2012 |
| 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
|
-
For screening, aclinical examination performed to verify
inclusion criteria and exclusion criteria.
- After the clinical examinations, the reference
listed drug Tenovate Cream will be
applied at any 2 sites on the body (as determined), except on the inner forearm
of b
- The
applied product will be left non occluded for a period of 4 hours after which
the product will be wiped gently with a cotton swab or washed with a mild
cleanser.
- Visual assessment of the site will be
carried out, 2 hours after the product has been wiped, in order to detect Responder Status of the volunteer.
Subjects who have the capacity to vasoconstrict when dosed with the
Reference Listed drug used in the study are called Responders. Dose
duration of 4 hours or 6 hours is suggested with skin blanching assessment
0-4 hours following drug product removal. A responder shows a visual
reading of at least one unit.
- On being detected as a Responder,
volunteer will be considered for the study.
- The forearm of each volunteer will be
cleaned with water and the volunteer will be acclimatised under controlled
conditions for 2 hours at the beginning of the trial.
- 8 patches of 4 cm2
area will be marked on flexor surface of the subjects’ forearm
- Baseline measurements will be carried
out thereafter.
- Following
which approximately 5 mg/cm2 of the Reference listed product
(quantity depending on patch size and potency of drug) will be massaged on
6 patches on forearm randomly for 1 min using a fingerstall. There will be
2 control sites on forearm and will be left untreated as reference sites.
- Following application, all the
patches will be kept open.
- Of the 6 product patches
applied on forearm ( D1, D2, 2 TP, 2 RLD) the patches marked TP (test) and
RLD (reference) will be kept non occluded for dose duration equal to ED50,
D1 and D2 as pre decided.
- Vasoconstriction
will be measured by the degree of skin blanching observed using a
Spectrophotometer (‘a’ scale reading) and Evaluations will be performed at
pre-dose (baseline) and at 0, 2, 4, 6, 19 and 24 hours after removal of
product .
|