| CTRI Number |
CTRI/2025/02/080824 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
10/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Study for anti dandruff shampoo] |
| Study Design |
Other |
|
Public Title of Study
|
A STUDY TO CHECK THE EFFECTIVENESS AND SAFETY OF ANTI DANDRUFF SHAMPOO IN ADULTS FOR 4 WEEKS |
|
Scientific Title of Study
|
A SINGLE CENTRE, OPEN LABEL STUDY TO EVALUATE EFFECTIVENESS AND SAFETY OF CICLOPIROX SHAMPOO (8X SHAMPOO) IN ADULTS WITH SCALP SEBORRHOEIC DERMATITIS |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2324CICL030 version 02 dated 13 Dec 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pranami Kashyap |
| Designation |
MD, Dermatologist |
| Affiliation |
Centre International De Drug Pharmacetique |
| Address |
32-B, 1st Floor, Rajinder Nagar, Pusa Road
Room: Dermatology room
Central
DELHI
110005
India |
| Phone |
01140793385 |
| Fax |
|
| Email |
p.kashyap@cidp-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pranami Kashyap |
| Designation |
MD, Dermatologist |
| Affiliation |
Centre International De Drug Pharmacetique |
| Address |
32-B, 1st Floor, Rajinder Nagar, Pusa Road
Room: Dermatology room
Central
DELHI
110005
India |
| Phone |
01140793385 |
| Fax |
|
| Email |
p.kashyap@cidp-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Yogesh Sharma |
| Designation |
Clinical Trial Manager |
| Affiliation |
Centre International De Drug Pharmacetique |
| Address |
32-B, 1st Floor, Rajinder Nagar, Pusa Road
Room: Evaluation room
Central
DELHI
110005
India |
| Phone |
09560745615 |
| Fax |
|
| Email |
y.sharma@cidp-cro.com |
|
|
Source of Monetary or Material Support
|
| CIPLA LTD. LBS Marg, Vikhroli(W), Mumbai 400083, India |
|
|
Primary Sponsor
|
| Name |
Cipla Ltd |
| Address |
Cipla Ltd LBS Marg Vikhroli(W) Mumbai 400083 India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Pranami Kashyap |
CIDP Biotech India Pvt. Ltd. |
32-B, 1st Floor, Rajinder Nagar, Pusa Road
New Delhi 110005, India
Central
DELHI |
9089348156
p.kashyap@cidp-cro.com |
| Yogesh Sharma |
CIDP Biotech India Pvt. Ltd. |
32-B, 1st Floor, Rajinder Nagar, Pusa Road
New Delhi 110005, India
Central
DELHI |
9560745615
y.sharma@cidp-cro.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Good Society for Ethical Research: |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Seborrheic dermatitis, unspecified |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Anti dandruff Shampoo
(Ciclopirox) |
Participants are instructed to
apply Ciclopirox shampoo (8x
shampoo) twice a week (on the
specified days) throughout the
study duration and to refrain
from using any other shampoos,
conditioners, oils, serums, hair
treatments and procedures
unless specifically advised by
the study team The Ciclopirox
shampoo (8x shampoo) must be
left on the scalp for 3 minutes to
allow the active ingredients to
work effectively; a timer may be
used to ensure the correct
duration. After the contact time,
the Ciclopirox shampoo (8x
shampoo) should be rinsed
thoroughly with lukewarm water
to ensure complete removal |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1Healthy male and female participants at 18-45 years of age with mild to moderate SSD.
2Participants willing and capable of following the study rules, requirements and fixed schedule.
3Female participants who have a negative pregnancy test as verified by urine pregnancy test to be done on baseline visit (Day 0) and agree to use acceptable methods of contraception for the duration of the study.
4Participants who can understand, read and write the study documents (in their preferred language) and are willing to give the written informed consent.
5Participants agreeing to use only the investigational product on the scalp provided by centre throughout the study duration
6Participants agree not to use any other shampoos, conditioners, oils, serums, hair treatments, hair procedures, or other hair products during the study duration. |
|
| ExclusionCriteria |
| Details |
1.Participants not matching one of the above-described eligibility
criteria.
2.Participants are either pregnant or breast feeding or planning to get
pregnant during the study period.
3.Participants who have started, stopped or changed his/her
hormonal treatment (including
contraceptive pill) in the previous one month or prior to the study.
4.Participants with any medical condition that, in the opinion of the
Investigator, would
jeopardize the health of the patient during the course of this study.
5.Known allergies to cosmetics and ingredients of test products.
6.Participants undergoing any topical or systemic treatment that
could interfere with the study treatments/assessments
(anti-seborrheic products, antibiotics, corticosteroids, retinoids,
antiinflammatory drugs) taken within the last 4 weeks prior to
participation in the study, and during
the study.
7.Participants under any topical and/or systemic medications, such
as anti-fungal medications, corticosteroids or immunosuppressive
medications, NSAIDs, antihistamines, etc., that may interfere with
the efficacy or safety assessment of the test product.
8.Participants with severe disorders within the last 6 months, e.g.
cancer, circulatory disorders, serious diabetes or other scalp
conditions that, in the Investigators judgment, may interfere with the
study procedure.
9.Participants who are intellectual/ mental inability to follow study
instructions (if suspected) or incapacitation.
10.Participants having participated in the last 30 days before
screening or currently participating in another clinical study.
11.Participant who are unable to contacted by phone in case of
emergency. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To check effectiveness of anti dandruff shampoo in reducing dandruff over a period of 4 weeks |
Day 0, Day 5, Day 13, Day 21, Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the effectiveness of the test product
in improving the quality of life, assessed using
the Scalpdex Questionnaire.
To evaluate the safety and cutaneous
acceptability of the test product by monitoring
local intolerances and adverse events through
dermatologist assessments.
To assess the test product based on
organoleptic characteristics and product
perception through participant self-assessment
questionnaires. |
The outcome of the study is to determine
whether the study product, when used twice
daily for 28 days, is effective in preventing the
recurrence of scalp seborrheic dermatitis. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/02/2025 |
| Date of Study Completion (India) |
04/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
04/04/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="28" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Study Population: Number of Subjects: 30 Demographics: males and females with SSD (Scalp Seborrheic Dermatitis) Age Range: 18 to 45 years Completion Goal: Expected Completers: 25 subjects Study Visits: Visit 1: Screening visit (Day -7 to Day -1) Visit 2: Baseline (D0) (Timepoints: T0 and T30 mins). Visit 3: Evaluation visit (Day 5) Visit 4: Evaluation visit (Day 13) |