| CTRI Number |
CTRI/2018/05/013774 [Registered on: 08/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
28/02/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmoceutical]] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate the efficacy of antidandruff hair leave on product on healthy human subjects
|
|
Scientific Title of Study
|
Evaluating Anti dandruff Efficacy of Hair Leave on Products on Healthy Human Subjects Based on Half Head Application Design.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MSCR/ITAD/2014-09 Version 1.0 dated 12 sep 2014 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrMukesh Ramnane |
| Designation |
Principal Investigator |
| Affiliation |
M.S Clinical Research Pvt Ltd |
| Address |
MS Clinical Research Pvt. Ltd,
327/15, 1st Main Road, Cambridge layout
Ulsoor, Bangalore
Bangalore
KARNATAKA
560008
India |
| Phone |
080-40917253 |
| Fax |
080-40917253 |
| Email |
mukesh.ramnane@mscr.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DrMukesh Ramnane |
| Designation |
Principal Investigator |
| Affiliation |
M.S Clinical Research Pvt Ltd |
| Address |
MS Clinical Research Pvt. Ltd,
327/15, 1st Main Road, Cambridge layout
Ulsoor, Bangalore
Bangalore
KARNATAKA
560008
India |
| Phone |
080-40917253 |
| Fax |
080-40917253 |
| Email |
mukesh.ramnane@mscr.in |
|
Details of Contact Person
Public Query
|
| Name |
DrMukesh Ramnane |
| Designation |
Principal Investigator |
| Affiliation |
M.S Clinical Research Pvt Ltd |
| Address |
MS Clinical Research Pvt. Ltd,
327/15, 1st Main Road, Cambridge layout
Ulsoor, Bangalore
Bangalore
KARNATAKA
560008
India |
| Phone |
080-40917253 |
| Fax |
080-40917253 |
| Email |
mukesh.ramnane@mscr.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ITC Life Science and Technology Centre |
| Address |
Peenya Industrial Area,
I Phase, Peenya
Bangalore- 560058
Karnataka, India
|
| Type of Sponsor |
Other [FMCG] |
|
|
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 |
| DrMukesh Ramnane |
M.S Clinical Research Pvt Ltd |
MS Clinical Research Pvt. Ltd,
327/15, 1st Main Road, Cambridge layout
Ulsoor, Bangalore-560008,
Karnataka, India
Bangalore
KARNATAKA |
080-40917253
080-40917253
mukesh.ramnane@mscr.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Clinicom,Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Male and Female with Moderate to Severe dandruff |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Antidandruff serum
1.Test product ADLOM198
2.Test product ADLOS226
|
Dose: 3.0 gm for each application.
Duration: 10 Weeks for each subject.
Frequency: Weekly Twice. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects who are willing to give signed informed consent and who consent to abide by the study protocol and restrictions for the entire study duration.
2.A mixed population of healthy male and female subjects in the age group of 20-45 yrs.
3.Subjects with preferably lengthy hair (for female subjects) but not mandatory.
4.Subjects with moderate to severe scalp dandruff score (with dandruff on both sides of the scalp).
5.Subjects with moderate to severe scalp itch score (Scoring based on subject’s feedback)
6.Subjects who have not participated in a similar investigation in the past four weeks.
7.Subjects who are not sensitive to the ingredients of the test product (As disclosed by the subjects or as observed during the Skin sensitivity test).
|
|
| ExclusionCriteria |
| Details |
1.Subjects with a known history or present condition of allergic response to any shampoo or conditioner.
2.Subjects having communicable skin/scalp infections or other skin disease (e.g. psoriasis, atomic dermatitis or other cutaneous manifestations), which could interfere with the test results as diagnosed by Dermatologist.
3.Subjects with severe hair fall due to endocrine disorders as diagnosed by dermatologist or revealed through oral interview.
4.Subjects on medications (steroids, antihistamines, antimicrobials), which would compromise the study results (Subjects inputs).
5.Female subjects who are pregnant (determined by Urine pregnancy test), lactating, or planning pregnancy during the course of the study (Subjects inputs).
6.Subjects with signs and symptoms of systemic and / or chronic illness (As diagnosed by Dermatologist)
7.Subjects who are regular users of anti- dandruff shampoo/ undergoing therapy for dandruff (Subjects inputs).
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
-Significant difference between the test products in conferring a reduction in dandruff symptoms.
-Significant difference between the test products in delaying the recurrence of dandruff symptoms.
-Significant difference between the test products in conferring improvement in hair quality and scalp health.
|
Approximately 10 Weeks for each subjects |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| -No significant difference between the test products in tolerability and efficacy in conferring scalp and hair attribute benefits. |
Approximately 10 Weeks for each subjct. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="39" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/09/2014 |
| Date of Study Completion (India) |
12/12/2014 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="15" |
|
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
|
primary Objective - To study the efficacy of test product in conferring superior reduction in dandruff symptoms and related discomfort compared to the reference product , to study the efficacy of test product in retarding / delaying dandruff recurrence compared to the reference product , to study the efficacy of the test product in conferring superior hair quality and scalp health compared to the reference product .
secondary objective - To study the tolerability and efficacy of the test products in conferring improved scalp health and hair attribute benefits.
sample size - Total of 50 healthy human adult subjects : male and female with moderate to severe dandruff.
study duration : Approximately 10 weeks for each subject.
study visits : Total 19 visits
study design : A controlled , parallel , comparative , randomized double blind study half head application design .
Main assessment parameters : dermatological visual assessment , black card assessment of falling flakes , hair fall count , and subject self assessment .
Results:The superior reduction in dandruff symptoms and related discomfort compared to the reference product wa observed. The retarding / delaying dandruff recurrence compared to the reference product was observed in some subjects. The iprovement in hair quality and scalp was observed in female subjects.The test product was well accepted by subjects.
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