| CTRI Number |
CTRI/2023/07/055579 [Registered on: 24/07/2023] Trial Registered Prospectively |
| Last Modified On: |
22/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Scalp Ecosystem Investigation on Asian Volunteers |
| Study Design |
Other |
|
Public Title of Study
|
Study to evaluate scalp in Asian population with dandruff scalp or without dandruff scalp. |
|
Scientific Title of Study
|
Scalp Ecosystem Investigation on Asian Volunteers with Dandruff Compared to Volunteers without Dandruff |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol 2223CICL060 Version 01 dated 29 Mar 2023 |
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 |
32-B, First floor, Rajendra Nagar, Pusa Road
Central
DELHI
110005
India |
| Phone |
9582645711 |
| 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 |
32-B, First floor, Rajendra Nagar, Pusa Road
Central
DELHI
110005
India |
| Phone |
9582645711 |
| Fax |
|
| Email |
a.jain@cidp-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Vidushi Bazaz |
| Designation |
Project Manager |
| Affiliation |
CIDP Biotech India Pvt. Ltd. |
| Address |
32-B, First floor, Rajendra Nagar, Pusa Road
Central
DELHI
110005
India |
| Phone |
9873348229 |
| Fax |
|
| Email |
v.bazaz@cidp-cro.com |
|
|
Source of Monetary or Material Support
|
| Singapore Centre for Environmental Life Sciences Engineering (SCELSE) Nanyang Technological University |
|
|
Primary Sponsor
|
| Name |
Singapore Centre for Environmental Life Sciences Engineering |
| Address |
60 Nanyang Drive, SBS-01N-27 Singapore 637551 |
| Type of Sponsor |
Other [[University] ] |
|
|
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 |
32-B, First floor, Rajendra Nagar, Pusa Road
Central
DELHI |
9582645711
a.jain@cidp-cro.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee-ACEAS |
Approved |
| NTU-IRB |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy male or female volunteer from 18 to 45 years old.
2.Asian population with skin type II-V per Fitzpatrick classification.
3.Female of childbearing potential who is not sexually active, or who is using an effective contraceptive method for at least one month before the beginning of the study and throughout the study.
4.Female of childbearing potential willing to undergo urine pregnancy test.
5.For dandruff volunteers:
a. Adherent dandruff score greater than 1.5(Loreal Dandruff Scale)
b. No limit for non-adherent dandruff score (Loreal Dandruff Scale).
6.For volunteer without dandruff: score 0 on each quadrant of scalp (Loreal Dandruff Scale).
7.Volunteer informed about the study objectives and procedures, and able to understand them, willing to fulfil the requirement and schedule.
8.Volunteer willing to give written informed consent and willing to comply with the study protocol and schedule.
9.Subject willing to use neutral shampoo for 3 weeks.Do not apply any cosmetics (gels, mousse, sprays, topical lotions, dyes, creams moisturising products or shampoo) on the scalp during 3-week wash out phase and 3 days before visit.Do not wet the hair (no swimming, aquatic sports, massages etc.) 3 days before testing visit.Do not comb their hair on the morning of the testing visit.
10.Absence of diagnosed skin-related condition (excluding seborrheic dermatitis).
11.With natural hair and hair length greater than and equal to 8cm.
12. Willing to have 30 hair follicles collection on the designated zone. 13. Willing to have swab sampling (2 X 2cm2, 2 areas) with hair parted on severest dandruff zone.
14. Willing to have 100 hairs cut on the scalp (on severest dandruff zone).
15. Willing to have one scalp biopsy (3mm in diameter) and one Follicle Unit Extraction (FUE 1.0 mm in diameter) collection on scalp.
16. Agree to take a COVID-19 RT-PCR test on neutral shampoo application visit.
|
|
| ExclusionCriteria |
| Details |
1. Volunteer who has BMI>30.
2. Volunteer with any medical or surgical record or scalp disease which in the opinion of the investigator might harm the volunteer or interfere with the present study.
3. Bald volunteer or without hair on top (equivalent to androgenic alopecia stage IV or more under the Hamilton classification amended by Norwood; NORWOOD OT. Male pattern baldness. Classification and incidence. South Med J, 1975, 68: 1359- 1365) for male, and hair loss symptom above I-2 with Ludwig scale for female.
4. Female volunteer who is known to be pregnant or who is intending to become pregnant over the duration of the study.
5. Female volunteer who is currently breast-feeding or has been breast-feeding in the 6 months prior to the start of the study.
6. Menopausal female (with absence of menstruations for less than one year) or post-menopausal female (with absence of menstruations for more than one year).
7. Volunteer who has used within the month before inclusion or plan to use during the study any systemic medications that can influence dandruff (e.g. antibiotics, steroidal and non-steroidal anti-inflammatory drugs, corticoids,) or which in the opinion of the principal investigator can influence the study.
8. Volunteer who has taken a retinoid within the past 6 months and/or intend to take it during the study period.
9. Volunteer who has used a topical corticosteroid or a topical antifungal medicinal product locally on the face and scalp during the two weeks prior to the start of the study and/or intend to use it during the study period.
10. Volunteer who has skin marks on the scalp that could interfere with the assessments (e.g. pigmentation, tattoo, scarring etc.)
11. Volunteer who has used products for the scalp (dyeing, bleaching etc.) within the 3 weeks prior to the study and/or intend to use it during the study period.
12. Volunteer who has used cosmetic anti-hair loss treatment (systemic or topical) during the last three months before the start of the study, or/and volunteer who has used medical anti-hair loss treatment (systemic or topical, ex: minoxidil, finasteride, etc.) during the last six months before the start of the study and/or intend to use it during the study period.
13. Volunteers with an immunocompromised state or infectious diseases like HIV, Cancer, Diabetes, Hepatitis, Syphilis, Herpes, etc. which in the opinion of the investigator can influence the study assessments and procedures.
14. Volunteer regularly engaging in aquatic or nautical sports and/or regularly having saunas.
15. Volunteer who has been excessively exposed to sun or UV during the past month (at the discretion of the investigator).
16. Volunteer with a history of cardiovascular or circulatory problems.
17. Volunteer who has taken part in a clinical trial, the exclusion period for which is not over or currently participating in another clinical trial.
18. Volunteer deprived of their liberty by a court or administrative ruling.
19. Having used other medication which in the opinion of the investigator might harm the volunteer or interfere with the present study.
20. Volunteer who cannot be contacted by phone in case of emergency.
21. Volunteer belonging to the staff of the investigating centre.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To investigate the presence of biofilms, microbiome composition, microbial
metabolites, & oxidative stress indicators on scalp and hair follicle, and measure hair fibre properties by comparing volunteers with dandruff versus volunteers without dandruff through microbiome, metabolites and visualisation evaluations. |
Visit 1(D-21)
Visit 2(D-3)
Visit 3(D0) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-To identify immunological & differentiation changes in hair follicles by follicular unit extraction (FUE).
-To compare scalp characteristics between volunteers with dandruff versus volunteers without dandruff through instrumental evaluation, clinical grading
and imaging. |
Visit 1(D-21)
Visit 2(D-3)
Visit 3(D0) |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="45" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/08/2023 |
| Date of Study Completion (India) |
19/08/2023 |
| Date of First Enrollment (Global) |
04/08/2023 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="21" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
- To investigate the presence of biofilms, microbiome composition, microbial metabolites, and oxidative stress indicators on scalp and hair follicle, and measure hair fibre properties by comparing volunteers with dandruff versus volunteers without dandruff through microbiome, metabolites and visualisation evaluations.
- To identify immunological and differentiation changes in hair follicles by follicular unit extraction (FUE) - To compare scalp characteristics between volunteers with dandruff versus volunteers without dandruff through instrumental evaluation, clinical grading and imaging.
|