| CTRI Number |
CTRI/2017/08/009424 [Registered on: 21/08/2017] Trial Registered Prospectively |
| Last Modified On: |
09/08/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Anti-lice products testing for safety and efficacy] |
| Study Design |
Other |
|
Public Title of Study
|
To test the safety and effectiveness of products in killing lice |
|
Scientific Title of Study
|
Clinical evaluation of the cutaneous tolerance and efficacy of single or two treatment application of herb based anti-lice product(s)under dermatological control
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 1617CICL417 Protocol Version 01 dated 31 Jul 2017 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Annie Jain |
| Designation |
Principal Investigator |
| Affiliation |
CIDP Biotech India Pvt. Ltd |
| Address |
32B First Floor, Rajinder Nagar, Pusa Road, New Delhi
Central
DELHI
110005
India |
| Phone |
01140793385 |
| Fax |
|
| Email |
a.jain@cidp-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Annie Jain |
| Designation |
Principal Investigator |
| Affiliation |
CIDP Biotech India Pvt. Ltd |
| Address |
32B First Floor, Rajinder Nagar, Pusa Road, New Delhi
Central
DELHI
110005
India |
| Phone |
01140793385 |
| Fax |
|
| Email |
a.jain@cidp-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Deepika Arora |
| Designation |
Study Manager |
| Affiliation |
CIDP Biotech India Pvt. Ltd |
| Address |
32B First Floor, Rajinder Nagar, Pusa Road New Delhi
Central
DELHI
110005
India |
| Phone |
01140793385 |
| Fax |
|
| Email |
d.arora@cidp-cro.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dabur Research Foundation |
| Address |
22, Site IV, Sahibabad,
Ghaziabad
Uttar Pradesh : 201010, India |
| 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 Annie Jain |
CIDP Biotech India Pvt. Ltd. |
32B First Floor, Rajinder Nagar, Pusa Road, New Delhi
Central
DELHI |
09582645711
a.jain@cidp-cro.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACEAS – Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Both male and female volunteers with head lice infestation aged 3 to 15 years (both
inclusive) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
1% PerliceTM crème rinse |
Product 3 : 1% PerliceTM crème rinse(Formula No. Not Applicable)
Product 3 will be applied in sufficient quantity to cover entire scalp and
hair from root to tip, kept for 10 minutes and washed
Frequency: For 10 minutes on Day 0 and Day 10
Route of Application: Topical Application
Total duration of treatment: 11 Days |
| Intervention |
SR-10 anti-lice drops and SR-20 anti-lice shampoo |
Product 1: Anti-lice Drops(Formula No. SR-10-Drops)
Product 1 will be applied in sufficient quantity and gently massaged to
cover entire scalp and hair from root to tip, kept for 10 minutes, followed
by application of shampoo (Product 2)
Frequency: For 10 minutes on Day 0 and Day 10
Route of Application: Topical Application
Total duration of treatment: 11 Days
Product 2: Anti-lice Shampoo(Formula No.SR-20-Shampoo)
Product 2 will be applied in sufficient quantity and gently
massaged to cover entire scalp and hair from root to tip, kept for 10 minutes and then washed
Route of Application: Topical Application
Total duration of treatment: 11 Days |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1 Healthy Indian male and female subjects
2 Age from 3 to15 years (both inclusive)
3 Subjects presenting with lice infestation of
scalp and having at least five live lice and
five eggs
4 Subjects with short , medium or long length hair
5 Subjects with straight or wavy or curly hair.
6 Subject willing and capable to follow the study rules and a fixed schedule
7 Subject/ Subject’s LAR able to give written informed consent and to comply with the
requirements of the study |
|
| ExclusionCriteria |
| Details |
1 Subjects not matching one of the above
mentioned inclusion criteria
2 Subject having any acute skin irritation or
diseases on the application site
3 Known hypersensitivity to any of the study
products or constituents (positive reaction
in Epicutaneous sensitivity testing)
4 Any significant medical condition or drug
history that would interfere with the study
assessments
5 Subjects with dermatological disorders which
could interfere with the evaluation of the
product tested
6 Subjects with intellectual/ mental inability
to follow study instructions (if suspected) or
incapacitation
7 Participation in any other clinical trial up
to 1 month prior to inclusion and during the
study. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of anti-lice efficacy of investigational products in comparision to a already marketed product by count of lice and nymphs before and after product application |
T0 (before product application) &
T30 (approximately 30 minutes after initiation of product application) at Day 0 and Day 10, and at
a single time point on Day 5 and Day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.The number of reported AE/ LI throughout the study will be used to assess the cutaneous safety and tolerance by the investigator
2. Perception of efficacy, tolerance and organoleptic characteristics of the product through responses
to subjective evaluation questionnaire by subjects/subject’s LAR
3. Count of eggs which hatch into nymphs after incubation of eggs collected |
1.Evaluation of number of AE/LI reported through out the study
2.Subjective evaluation questionnaire by subjects/subject’s LAR at Day 0 (T0 & T30min), Day 5,
Day 10 (T30min) and Day 14
3.Collection of eggs at Day0T0 ,Day0T30 min,Day10T0 and Day10T30min |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "39"
Final Enrollment numbers achieved (India)="39" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/08/2017 |
| Date of Study Completion (India) |
22/09/2017 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The objective of this study are: Primary objective(s) The primary objective of the study is to assess the anti-lice efficacy of a shampoo alone and drops in combination with shampoo, in a single- or two-treatment application with comparison to a marketed formulation. Secondary objective(s) The secondary objectives of this study are as follows: • Assessment of cutaneous safety and tolerance by the Principal Investigator through AE/LI monitoring •Appreciation of the efficacy, tolerance and organoleptic characteristics of the product through subjective evaluation questionnaire • Photo documentation of the eggs (collected from hair strands) and analysis of the ovicidal activity of the test products, will be done as an exploratory objective by Dabur Research Foundation
Sample Size: 40 male and female subjects |