| CTRI Number |
CTRI/2022/08/044605 [Registered on: 03/08/2022] Trial Registered Prospectively |
| Last Modified On: |
13/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceutical] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study to evaluate the safety and efficacy of Stretchmark Oil & Oil Free Hair Oil in healthy pregnant females and lactating females. |
|
Scientific Title of Study
|
An open-label, single-arm study to evaluate the efficacy and safety of a Stretchmark Oil & Oil Free Hair Oil in healthy pregnant female (1st and 2nd trimester) and lactating female (post pregnancy mother having 0 month to 3 months old baby) subjects. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C3B00917 Version: 01, Dated 15 Jul 22 |
Protocol Number |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| 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 |
917966219549 |
| Email |
pjoshi@ofacto.com |
|
Details of Contact Person
Scientific Query
|
| 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
GUJARAT
380054
India |
| Phone |
8000085049 |
| Fax |
917966219549 |
| Email |
pjoshi@ofacto.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Simran Sethi |
| Designation |
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 |
917966219549 |
| Email |
ssethi@ofacto.com |
|
|
Source of Monetary or Material Support
|
| Zydus Wellness Ltd.
Plot No 115/5 TP Scheme No 51,
Beside Bliss Apartment,
Opp Viola Apartment,
Ambli Bopal Road,
Ahmedabad 38001, India |
|
|
Primary Sponsor
|
| Name |
Zydus Wellness Ltd |
| Address |
Plot No 115/5 TP Scheme No 51,
Beside Bliss Apartment,
Opp Viola Apartment,
Ambli Bopal Road,
Ahmedabad 38001, India |
| Type of Sponsor |
Other [Health and Hygiene] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Parth Joshi |
Cliantha Research |
Consumer Research Department,
Garden View Corporate House No 7,
Opp Auda Garden,
Bodakdev, Ahmedabad 380054, India
Ahmadabad
GUJARAT |
8000085049
917966219549
pjoshi@ofacto.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| OM |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R238||Other skin changes, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Oil Free Hair Oil |
Apply/spray approx. 5 gm/ml of hair oil on the roots and scalp.
Product will be applied twice/thrice a week for a period of 30 days. |
| Intervention |
Stretchmark Oil |
Approx. 3 gm of test product to be applied on the abdominal scar area and arms /thighs /buttocks /chest in a similar way.
Product to be used twice daily for a period of 60 days.
For subjects without stretchmarks: Approx. 3 gm of test product to be applied on the abdominal area by gently massaging the product in a circular motion. Apply the equivalent quantity of product on arms /thighs /buttocks /chest in a similar way. For smaller areas, squeeze the required quantity onto your fingertips and for larger areas use palm for product application. Product will be used twice daily (morning & evening). |
|
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Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1) Sex: Females, either of the following
a. Healthy pregnant females (1st and 2nd Trimester).
b. Lactating females (post pregnancy mothers having 0 to 3 months old baby).
2) Subjects having stretch mark on their abdomen at the time of enrollment.
3) Atleast 12 healthy pregnant females (1st and 2nd trimester) without stretchmarks will be enrolled.
4) Subjects complaining of having at least 50 to 100 hair fall per day.
5) Subjects with 50 counts of hair fall from hair combing method (60-sec hair count) at screening visit (if screening and enrollment on same day) or on enrollment day before test product application.
6) For Post Pregnancy Mothers: Subjects having history of delivery within 42 weeks.
7) For Pregnant females: Primipara (woman who is giving birth for the first time) subjects, who are diagnosed as pregnant female by gynaecologist. |
|
| ExclusionCriteria |
| Details |
1) Subjects with a history of severe hair fall due to any clinically significant problems/s like anaemia, thyroid problems etc.
2) History of any dermatological condition of the scalp other than hair loss and/or dandruff.
3) History or present condition of irritated or visibly inflamed scalp or severe scalp disease.
4) Skin disease (e.g., moderate to severe acne vulgaris face or nodulocystic acne, psoriasis, atopic dermatitis or any other condition as per Investigator’s discretion), which would interfere with the test readings.
5) Participation in a similar clinical study within the previous 90 days. |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
1)Dermatological assessment of abdominal scar using the Patient/subject and Observer Scar Assessment scale (POSAS) and Vancouver’s Scar Scale (VSS).
2)Assessment of skin elasticity and firmness of abdominal area using Cutometer.
3)Dermatological assessment of prevention of abdominal scar using the Vancouver’s Scar Scale (VSS).
4)Assessment of hair fall reduction using 60-s Hair count technique.
5)Dermatological assessment of Hair Strength using Pull test. |
Baseline, Day 5, Day 15, Day 30 and Day 60 |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Dermatological assessment of scar using Goodman & Baron’s scales classification. |
Baseline, Day 5, Day 15, Day 30 and Day 60 |
| Assessment of abdominal scar measurement using Digital Vernier Calipers. |
Baseline, Day 5, Day 15, Day 30 and Day 60 |
| Assessment of scalp condition using Phototrichogram by CASlite Nova. |
Baseline, Day 5, Day 15, Day 30 and Day 60 |
| Assessment of % anagen hairs, percent telogen hairs and A:T ratio using ‘Hair Pluck Test’ and Microscopic Evaluation. |
Baseline, Day 5, Day 15, Day 30 and Day 60 |
| Assessment of oiliness of scalp using Sebumeter. |
Baseline, Day 5, Day 15, Day 30 and Day 60 |
| Dermatological assessment of general appearance of hair. |
Baseline, Day 5, Day 15, Day 30 and Day 60 |
| Dermatological assessment of appearance of scalp skin. |
Baseline, Day 5, Day 15, Day 30 and Day 60 |
| Subject Satisfaction Questionnaire and Product Response Index (Perception about Product). |
Baseline, Day 5, Day 15, Day 30 and Day 60 |
| Digital photographs of stretchmarks and hair/scalp. |
Baseline, Day 5, Day 15, Day 30 and Day 60 |
|
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Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "53"
Final Enrollment numbers achieved (India)="53" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/08/2022 |
| Date of Study Completion (India) |
15/01/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
The potential
subjects will be screened as per the inclusion and exclusion criteria only
after obtaining written informed consent from the subjects.
There are total 6 visits in the study i.e.
·
Visit 01: Screening Visit (within 30
days prior to day 01)
·
Visit 02: Enrollment (Day 01)
·
Visit 03: Evaluation phase (Day 5)
·
Visit 04: Evaluation phase (Day 15)
·
Visit 05: Evaluation phase (Day 30)
·
Visit 06: Evaluation phase and End of
the study (Day 60)
Before
entering the facility, at security check-post, subjects will be asked for
pre-entry scrutiny check for COVID-19 symptoms. Study can be conducted in
multiple batches (set of subjects) in order to follow the norms of covid-19
restrictions.
Instrumental
assessment, dermatological assessments and questionnaires will be assessed.
Safety will be assessed throughout the study by monitoring of adverse events.
|