| CTRI Number |
CTRI/2021/06/034226 [Registered on: 14/06/2021] Trial Registered Prospectively |
| Last Modified On: |
10/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [consumer research – Anti Dandruff study] |
| Study Design |
Other |
|
Public Title of Study
|
Anti-Dandruff Shampoo Testing on healthy male and females adult subjects. |
|
Scientific Title of Study
|
An Open Label, Single-Arm, Multicentre, Clinical Study to Evaluate Efficacy and Safety of Anti-Dandruff Shampoo (HADR-111801S) in subjects with dandruff. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C3B00980 Version: 01, Dated 24 May 21 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Parth Joshi |
| Designation |
Principal Investigator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department
Garden View Corporate House No 7
Opp Auda Garden
Bodakdev Ahmedabad 380054 India
Ahmadabad
GUJARAT
380054
India |
| Phone |
8000085049 |
| Fax |
07966219549 |
| Email |
pjoshi@cliantha.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Parth Joshi |
| Designation |
Principal Investigator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department
Garden View Corporate House No 7
Opp Auda Garden
Bodakdev Ahmedabad 380054 India
Ahmadabad
GUJARAT
380054
India |
| Phone |
8000085049 |
| Fax |
07966219549 |
| Email |
pjoshi@cliantha.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Simran Sethi |
| Designation |
Associate Director - Consumer Research |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department
Garden View Corporate House No 7
Opp Auda Garden
Bodakdev Ahmedabad 380054 India
Ahmadabad
GUJARAT
380054
India |
| Phone |
9825784942 |
| Fax |
07966219549 |
| Email |
ssethi@cliantha.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
The Himalaya Drug Company |
| Address |
The Himalaya Drug Company
Makali, Bengaluru 562 162 India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mitisha |
Cliantha Research |
Cliantha Research
A Block Building No 2a
Noida sector
63 Gautam Buddha Nagar
Near Blue Dart Office
Uttar Pradesh 210301
Gautam Buddha Nagar
UTTAR PRADESH |
8130599975
mkjain@cliantha.com |
| Dr Parth Joshi |
Cliantha Research |
Consumer Research Department,
Garden View Corporate House No. 7
Opp. Auda Garden
Bodakdev
Ahmedabad 380054
Ahmadabad
GUJARAT |
8000085049
07966219549
pjoshi@cliantha.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 |
18 to 60 years adult male & female subjects having dandruff with ASFS score 24 to 48 will be included in the study |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cliantha Code A: Anti Dandruff
Shampoo HADR-111801S |
Anti Dandruff Shampoo:
Sufficient Quantity (depending upon length of hair) ; Topical application (Application on wet hair) ; Duration of Therapy: 28 days |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age: 18 to 60 years (both inclusive) at the time of consent.
2. Sex: Healthy male or non-pregnant/non-lactating female.
3. Female subjects of childbearing potential must have a negative urine pregnancy test performed on screening visit and Enrolment.
4. Subjects generally in good health and willing to give written informed consent and willing to follow study procedure.
5. Subjects with dandruff determined by ASFS score 24 to 48 with itching and flaking.
6. Subjects with visible flakes.
7. Subjects willing to refrain from using other products on the scalp other than those provided, including other shampoos/conditioners, scalp and hair treatment and oils/ products that has anti-dandruff action during the study period.
8. Subjects completing the conditioning phase.
9. Subjects willing to use test product throughout the study period.
10. Subjects must be able to understand and provide written informed consent to participate in the study.
11. Subjects should be willing and able to follow the study protocol to participate in the study. |
|
| ExclusionCriteria |
| Details |
1) History of any dermatological conditions of the scalp (other than dandruff or seborrheic dermatitis) that would interfere with the diagnosis or assessment (e.g. psoriasis, eczema, atopic dermatitis, or other skin/scalp infections).
2) Subjects with excessive erythema, crusting or a significant number of pustules/papules on the scalp.
3) History of skin cancer or treatment for any type of cancer within the last 2 years.
4) History of prior use of antidandruff treatment on scalp within past 1 month.
5) Participation in a similar clinical study within the previous 90 Days.
6) Subjects with a history or present condition of an allergic response to dandruff shampoos or any cosmetic products or component present in the test product.
7) Any other condition which could warrant exclusion from the study, as per the Dermatologist’s/investigator’s discretion. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The objective of this study is to evaluate the safety and efficacy of Anti-Dandruff Shampoo (HADR-111801S) in subjects with dandruff |
Day 01, Day 07, Day 15, Day 28, Day 30, Day 31 and Day 32 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
Final Enrollment numbers achieved (Total)= "102"
Final Enrollment numbers achieved (India)="102" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/06/2021 |
| Date of Study Completion (India) |
27/12/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="2" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Dandruff
is a common condition encountered in general population and it is also known as
Pityriasis capitis. It is said that dandruff affects at least 50% of the world’s
adult population and about 15-20% of the world’s total population. The peak
incidence and severity of dandruff occurs at approximately 20 years of age.
Dandruff is a common scalp condition,
characterized by presence of corneocytes that form clusters due to their high
cohesive power, in the form of flaky white to yellowish scales, accompanied by
itching. It has been observed that dandruff occurs mainly between puberty to
middle- age, the phase when sebaceous glands are most active.
This is an open label, single-arm, multicenter, clinical study to
evaluate efficacy and safety of Anti-Dandruff Shampoo (HADR-111801S) in subjects with dandruff. The potential subjects will be screened
as per the inclusion and exclusion criteria only after obtaining written
informed consent from the subjects. |