| CTRI Number |
CTRI/2024/10/074925 [Registered on: 08/10/2024] Trial Registered Prospectively |
| Last Modified On: |
04/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetics Study for Dandruff Study] |
| Study Design |
Other |
|
Public Title of Study
|
A study to test how safe and effective an anti-dandruff product is on males and females aged 18 to 45. |
|
Scientific Title of Study
|
A monocentric open label study to evaluate safety and efficacy of ciclopirox shampoo (8X shampoo) in males and females with scalp seborrhoeic dermatitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2324CICL030 version 01 dated 08 aug 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pranami Kashyap |
| Designation |
MD, Dermatologist |
| Affiliation |
CIDP Biotech India Pvt Ltd |
| Address |
32-B, 1st Floor, Rajinder Nagar, Pusa Road, New Delhi 110005, India
Central
DELHI
110005
India |
| Phone |
1140793385 |
| Fax |
|
| Email |
p.kashyap@cidp-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pranami Kashyap |
| Designation |
MD, Dermatologist |
| Affiliation |
CIDP Biotech India Pvt Ltd |
| Address |
32-B, 1st Floor, Rajinder Nagar, Pusa Road, New Delhi 110005, India
Central
DELHI
110005
India |
| Phone |
1140793385 |
| Fax |
|
| Email |
p.kashyap@cidp-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Yogesh Sharma |
| Designation |
Clinical Trial Manager |
| Affiliation |
CIDP Biotech India Pvt Ltd |
| Address |
32-B, 1st Floor, Rajinder Nagar, Pusa Road, New Delhi- 110005, India
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 |
LBS Marg, Vikhroli(W), Mumbai 400083 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 |
| Yogesh Sharma |
CIDP Biotech India Pvt. Ltd. |
(CRO) 32-B First floor Third floor Rajendra 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 |
| Patients |
(1) ICD-10 Condition: L219||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 |
Nil |
Nil |
|
|
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
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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. |
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. |
|
|
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)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="28" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Suspended |
|
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)
- Visit 5: Evaluation visit (Day 21)
- Visit 6: End of study (Day 28 + 1)
|