| CTRI Number |
CTRI/2025/09/095346 [Registered on: 24/09/2025] Trial Registered Prospectively |
| Last Modified On: |
24/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [[cosmetic product for efficacy and safety evaluation]] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Consumer perception for Almond hair oil |
|
Scientific Title of Study
|
An Open-Label Clinical Study to Assess the Dermatological Safety Efficacy and
Consumer Reported Outcomes of The Body Shop Almond hair oil in Healthy Adult male and female
participants |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ARL/CT/030/25 Version No 01 Dated 10 Sep 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Karishma Kapoor |
| Designation |
Principle Investigator |
| Affiliation |
Auriga Research Private Limited |
| Address |
3/17 2nd Floor Cosmetic Division Kirti Nagar Industrial State New Delhi
New Delhi
New Delhi
DELHI
110015
India |
| Phone |
09871953143 |
| Fax |
|
| Email |
karishma.kapoor@aurigaresearch.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Karishma Kapoor |
| Designation |
Principle Investigator |
| Affiliation |
Auriga Research Private Limited |
| Address |
3/17 2nd Floor Cosmetic Division Kirti Nagar Industrial State New Delhi
New Delhi
DELHI
110015
India |
| Phone |
09871953143 |
| Fax |
|
| Email |
karishma.kapoor@aurigaresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Karishma Kapoor |
| Designation |
Principle Investigator |
| Affiliation |
Auriga Research Private Limited |
| Address |
3/17 2nd Floor Cosmetic Division Kirti Nagar Industrial State New Delhi
New Delhi
DELHI
110015
India |
| Phone |
09871953143 |
| Fax |
|
| Email |
karishma.kapoor@aurigaresearch.com |
|
|
Source of Monetary or Material Support
|
| Quest Retail Private Limited
DLF Infinity tower A 7th Floor DLF Cyber city M G Road Gurgaon 122002 DLFphase 2 |
|
|
Primary Sponsor
|
| Name |
Quest Retails private Limited |
| Address |
DLF Infinity tower A 7th Floor DLF Cyber city M G Road Gurgaon 122002 DLFphase 2 |
| Type of Sponsor |
Other [Cosmetic manufacturer] |
|
|
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 Karishma Kapoor |
Auriga Research Private Limited |
3/17 2nd Floor Cosmetic Division Kirti Nagar Industrial State New Delhi
New Delhi
DELHI
110015
India
3/17 2nd Floor Cosmetic Division Kirti Nagar Industrial State New Delhi
New Delhi
DELHI
110015
India
New Delhi
DELHI |
09871953143
karishma.kapoor@aurigaresearch.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 |
Healthy Participants |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
The Body Shop Almond hair oil B No TBSA0825 |
The Body Shop Almond hair
oil twice a week at night approximately 5 10 ml depending on the hair length The test product will
be applied on the scalp and massaged gently over the hair and hair tips for 45 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Healthy male & female participants in the age group of 18 55 years both age inclusive
Participants having self perception of hair loss
Participants having damaged dull and dry hair
Participants willing to give voluntary written informed consent
Participants willing to apply Investigational Product & wash their hair twice in a week
Participants do not use any hair regrowth product or medicine except test products for hair growth
Participants whose screening hair fall count is minimum of 20
Participants having colored hair non colored hair in almost equal proportion If colored
hair then the minimum time frame from coloring to screening is 2 to 3 weeks
Participant is having apparently healthy skin on the test area and without any open
wounds cuts abrasions irritation symptoms on the test area
Participant willing to perform UPT
Participant willing to give a written informed consent and come for regular observation |
|
| ExclusionCriteria |
| Details |
Participants who are undergoing hair growth treatment 3 months before starting the study
Participants who have disorders like eczema scalp infection etc at the time of screening.
Participants who have treatments of actinotherapy or cancer chemotherapy within 6 months
before starting study or have a plan to do treatments of them during study terms
Participants who have hair transplant
Participants with Known hypersensitivity to any of the study products or constituents
Participant is Pregnant or Lactating
Participants participated in any other cosmetic or therapeutic trial or in a similar investigation
in the trial |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hair strenth and scalp & hair condition as well as consumer feedback on ease of use sensory attributes perceived benefits satisfaction and willingness to continue or recommend the product |
Day 0 Day 20 Day 45 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety & tolerability of the test product |
Day 0 Day 20 Day 45 |
|
|
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)
|
05/10/2025 |
| 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="1"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
The objective is dermatologist evaluations of hair strength and scalp & hair condition as well as consumer feedback on ease of use sensory attributes perceived benefits satisfaction and willingness to continue or recommend the product over the treatment period of 45 days |