| CTRI Number |
CTRI/2023/04/052032 [Registered on: 27/04/2023] Trial Registered Prospectively |
| Last Modified On: |
22/12/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
An efficacy study of a topical cream, ar-Turmerone on female subjects with hirsutism. |
|
Scientific Title of Study
|
A double-blinded, placebo-controlled, randomized, moncentric clinical study to assess the efficacy
of topical ar-Turmerone on female subjects with hirsutism over a period of 14 weeks. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CW/115/ART_HIRS/I/JAN/23 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mukta Sachdev |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research |
| Address |
Second floor, Evaluation room no. 1, 327/15, 1st Main Road,
Cambridge layout, Ulsoor Bangalore KARNATAKA 560008 India
Bangalore
KARNATAKA
560008
India |
| Phone |
08041125934 |
| Fax |
08040917253 |
| Email |
mukta.sachdev@msclinical.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Satish G |
| Designation |
Vice-President |
| Affiliation |
Sami-Sabinsa Group Limited |
| Address |
Sami-Sabinsa Group limited
No. 19/1 & 19/2, I Main, II Phase, Peenya Industrial Area, Bangalore.
KARNATAKA 560058 India
Bangalore
KARNATAKA
560058
India |
| Phone |
08028397973 |
| Fax |
|
| Email |
satish.g@clinworld.net |
|
Details of Contact Person
Public Query
|
| Name |
Mr Satish G |
| Designation |
Vice-President |
| Affiliation |
Sami-Sabinsa Group Limited |
| Address |
Sami-Sabinsa Group limited
No. 19/1 & 19/2, I Main, II Phase, Peenya Industrial Area, Bangalore.
KARNATAKA 560058 India
Bangalore
KARNATAKA
560058
India |
| Phone |
08028397973 |
| Fax |
|
| Email |
satish.g@clinworld.net |
|
|
Source of Monetary or Material Support
|
| Sami – Sabinsa Group Ltd. 19/1, 19/2, I Main, II Phase Peenya Industrial Area Bangalore –
560058 |
|
|
Primary Sponsor
|
| Name |
Sami-Sabinsa Group Ltd. |
| Address |
Sami – Sabinsa Group Ltd. 19/1, 19/2, I Main, II Phase Peenya
Industrial Area Bangalore – 560058 |
| Type of Sponsor |
Other [Manufactures and markets phytonutrients, standardized herbal extracts and nutritional supplements.] |
|
|
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 Mukta Sachdev |
MS Clinical Research |
Second floor, Evaluation room no. 1,
327/15, 1st Main Road,
Cambridge layout,
Ulsoor Bangalore
KARNATAKA 560008
India
Bangalore
KARNATAKA |
08041125934
08040917253
mukta.sachdev@msclinical.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Clinicom Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L680||Hirsutism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1. ar – Turmerone Cream |
1 FTU (Finger Tip Unit) must be
applied twice a day for 90 days. |
| Comparator Agent |
2. Placebo |
1 FTU (Finger Tip Unit) must be
applied twice a day for 90 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1. Subjects who are suffering from PCOD/PCOS.
2. Subjects
willing to participate in the trial.
3. Subjects must be able to
understand English or Kannada and provide an informed consent to
participate in the trial also allow a photography release and agree to
present themselves at the Study Center for regular follow-up.
4.
Subjects with a concern of visible facial hair (Hirsutism) with average score of more than 1 on Chin and Upper Lip area on the Modified
Ferriman-Gallwey Scoring.
5. Subjects agreeing to use the
provided investigational product provided during the study.
6.
Subjects informed about the study objectives and procedures, and
able to understand them.
7. Subjects willing and able to fulfill
the study requirements and schedule.
8. Subjects willing to
avoid oily, greasy, junk food and high-sugar food items, as much as
possible during the study period.
9. 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
a. (The effective
contraceptive methods: sexually active females of childbearing
potential should either be surgically sterile (oophorectomy,
hysterectomy, or tubal ligation), or should use a medically accepted
contraceptive regimen: diaphragm or cervical cap with intravaginal
spermicide, intravaginal device, intrauterine device (IUD), condom
with spermicide.)
10. Subject must agree not to use any other
product/treatment/home remedy/soap bar on their face during the
study period other than the test product having a hair removal or
reduction effect
11. Subjects must not carry out bleaching or
any other procedures including facial etc. on the face during the
study period.
12. Subjects must agree not to expose to
excessive sunlight. (Sun exposure not more than half an hour daily
and during that time use of umbrella to cover face).
13.
Subjects must agree to remove all jewelry on/around face (e.g.,
necklace, earrings, if possible, nose ring), during Digital imaging.
14. Subjects willing to give a voluntary written informed
consent, photography release and agree to come for regular follow
up.
15. Subjects willing to abide by and comply with the study
protocol.
16. Subjects must not have participated in a similar
investigation in past four weeks.
17. Subjects who are willing
not to participate in any other clinical study during participation in the
current study. |
|
| ExclusionCriteria |
| Details |
Subjects who are pregnant or lactating or who are planning to
become pregnant during the study.
2. Sexually active female subjects of child bearing potential who are
on oral contraceptive pills
3. Those who received drugs known to cause hirsutism or interfere
with hormonal studies.
4. Women with Cushing syndrome and CAH as per the medical
examination and blood test report.
5. Subjects having severe illness like hypertension, ovarian cancer or
any other form of malignancy, thyroid dysfunction.
6. Women who are having hypertrichosis.
7. Women who are taking following medications: androgens,
glucocorticosteroids, progestins, acetazolamide, latanoprost,
streptomycin, psoralen, estrogen antagonists (clomiphene,
tamoxifen), minoxidil, cyclosporine, danazol, diazoxide, phenytoin,
D-penicillamine, and interferon.
8. Subject who is under the treatment/care of a dermatologist/
gynecologist.
9. History of allergies, hypersensitivity or any serious reactions to
any cosmetic products.
10. Any significant skin pathology in the test areas, like rosacea, or
eczema.
11. Any significant medical condition that would interfere with the
participation in the study, as per the opinion of the Investigator.
12. Any concomitant medical/surgical condition or using medication which may harm the subject or interfere with the study assessments, as per opinion of the Investigator.
13. Any dermatological procedure on the test areas (laser peel,
dermabrasion etc.) taken 4 weeks before the start of the study and
during the study.
14. Having participated in the last 30 days before screening or
currently participating in another clinical study.
15. Unable to be contacted by phone in case of emergency. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Significant reduction in the following
parameters based on Trichoscan Image
Analysis:
a. Facial Hair Density (n per cm2) on Months 1,
2 and 3 in comparison to Baseline.
b. Facial Hair Diameter (?m) on Months 1, 2 and
3 in comparison to Baseline
c. Facial Hair Growth Rate (mm per day) on
Months 1, 2 and 3 in comparison to Baseline
• Significant reduction in the following
parameters based on Dermatological Visual
Assessment:
a. Modified Ferriman-Gallwey Score |
Baseline, Month 1, Month 2 and Month 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Significant reduction in Hirsutism Score as
assessed by the Modified Ferriman-Gallwey
Scoring System.
• Product safety in a long-term use as per the
Safety Assessment by AE/LI monitoring by
Dermatologist.
• Product Acceptability and Likability as per the
Subject Self-Assessment Questionnaire
including Organoleptic Properties of the Test
Product. |
Baseline, Month 1, Month 2 and Month 3 |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
Final Enrollment numbers achieved (Total)= "33"
Final Enrollment numbers achieved (India)="33" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/04/2023 |
| Date of Study Completion (India) |
12/10/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study will be conducted for a period of approximately 14 weeks including a washout period of up to 2 weeks and a treatment period of 12 weeks. Subjects will be screened and asked to give written informed consent. They will be asked to visit the study centre on the 3rd, 4th or 5th day of their menstrual cycle and provide their blood sample. Subjects will be screened further based on the results of the blood test. Subjects will be called to the study centre for baseline, Month 1, Month 2 and Month 3 assessments. Blood sampling will be done for hormonal profiling. Subjects will be called 1-week post-study and asked to answer a questionnaire. |