| CTRI Number |
CTRI/2012/08/002906 [Registered on: 23/08/2012] 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 safety of test products for skin irritation |
|
Scientific Title of Study
|
Evaluation of the safety of test products for primary skin irritation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CL/017/0712/STU; Version No.: 1 of 26th July 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),
MAHARASHTRA
400058
India |
| Phone |
66758851 |
| Fax |
66758854 |
| Email |
rsjdr@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Trupti Chitre |
| Designation |
Executive, Pharma R&D |
| Affiliation |
Cipla Ltd |
| Address |
Cipla Ltd. Bldg. NO.14, L.B.S. Marg
Vikhroli (W)
Mumbai
MAHARASHTRA
400 083
India |
| Phone |
2576800 |
| Fax |
25712692 |
| Email |
trupti.chitre@cipla.com |
|
|
Source of Monetary or Material Support
|
| Cipla Ltd
Bldg. NO.14, L.B.S. Marg
Vikhroli (W), Mumbai 400 083. |
|
|
Primary Sponsor
|
| Name |
Cipla Ltd |
| Address |
Bldg. NO.14, L.B.S. Marg
Vikhroli (W), Mumbai 400 083. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| None |
Not Applicable |
|
|
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 SLS responders |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.9% isotonic saline solution |
0.9% isotonic saline solution will be used as negative control for comparison with Lumacip cream only
0.04 ml or g (as applicable) occlusion will be 24 hours. |
| Intervention |
Lumacip Cream |
Hydroquinone cream 2%
0.04 ml or g (as applicable)
occlusion will be 24 hours. |
| Intervention |
Lumacip Plus cream |
Fluocinolone acetonide cream 0.01 % + Hydroquinone cream 4 % + Tretinoin cream 0.05 %
0.16 g of sample will be applied on the marked test site and will be rubbed in for 30 seconds and kept on for 30 minutes.
The same procedure is repeated everyday till 5 applications are completed. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Voluntary men and/or women.
2. SLS responders from database or determined by applying SLS patch on volunteers.
3. Between 18 and 65 years.
4. Photo type III and IV.
5. Having apparently healthy skin on test area.
6. Willingness to discontinue the use of cleansing and/or cosmetic products in the treatment areas during the course of the study.
7. For whom the investigator considers that the compliance will be correct.
8. Cooperating, informed of the need and duration of the examinations, and ready to comply with protocol procedures.
9. Having signed a Consent Form and will be once informed orally and in writing of all information concerning the study procedures and study objectives.
10. Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the study.
11. Willingness to avoid water contact (i.e.: swimming) or activity which cause sweating (i.e.: exercise, sauna…), during the course of the study.
12. Ready to wear loose cotton clothes.
|
|
| ExclusionCriteria |
| Details |
1. People who have a job involving water contact or a job which causes perspiration. (Routine work can be done. No carrying out activities like excessive/brisk walking, exercising etc).
2. Pregnant women and lactating women. (as confirmed by UPT)
3. Scars, excessive terminal hair or tattoo on the studied area.
4. Dermatological infection/pathology on the level of studied area.
5. Hypersensitivity, allergy antecedent (to any cosmetic product, raw material).
6. Any clinically significant systemic or cutaneous disease, which may interfere with study treatments or procedures.
7. Subjects on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month).
8. Subject in an exclusion period or already participating in another similar cosmetic or therapeutic trial as identified during screening on visit 1 (V1).
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the cutaneous tolerance by dermatological scoring of skin reactions using Draize scale.
|
To evaluate the cutaneous tolerance by dermatological scoring of skin reactions using Draize scale.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
Nil |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "35"
Final Enrollment numbers achieved (India)="35" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/08/2012 |
| Date of Study Completion (India) |
12/09/2012 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="15" |
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
|
·
It is a test under dermatological control, monocentric,
randomized, double blinded, controlled and comparative versus negative control.
·
There
will be 4 Products involved in the study- 2 test products, 1 negative control
(0.09% isotonic saline solution) and 3% Sodium Lauryl sulphate solution
wherever applicable.
Procedure
to be followed for occluded patch test.
·
Procedure
for making 3% w/w solution of SLS: Weigh 0.3 g of sodium Lauryl
sulphate in a tarred beaker. Add sufficient quantity of water to make up the
weight to 10 g.
·
At V1 (0
hrs) :0.04 ml or g (as applicable)
of the test products, negative control (0.9% isotonic saline solution) and 3%
solution of sodium lauryl sulphate will
be filled in different wells of Patch chambers and will be applied occlusively on upper arms
of each volunteer by C.L.A.I.M.S. personnel
at Hour 0. Duration of occlusion will be 24 hours.
·
The Test Products will be filled in Patch
chambers as per a randomization code generated by QA Department. Negative
Control and 3% Sodium Lauryl sulphate will not be randomized.
·
At V2:
(24 hrs): Patch will be removed and clinical examination of skin will be
carried out by Investigator.
·
At V3:
(48hrs.): Clinical examination and scoring of test area (skin on upper arm)
will be performed.
Procedure
to be followed for ROAT.
·
At V1,
2x 2 square cm test sites will be marked on the antecubital fossa of arm
without randomization.
·
Approximately 0.16 g of sample will be applied
on the marked test site. The Products will be rubbed in for 30 seconds gently
with finger stall and kept on for 30 minutes
·
After 30 minutes the volunteer will be allowed
to go.
·
The same procedure is repeated everyday till 5
applications are completed.
·
At V5, the
volunteer will wait for I hour after application of Products, the site will be washed
and graded thereafter.
·
Occluded Patch and ROAT reactions would be
graded using Draize scale.
If a reaction is observed, the subject will
be requested to return to research centre till reactions are resolved.
|