An efficacy study of a topical cream, ar-Turmerone on female subjects with hirsutism.

Not Applicable

Completed

• Conditions: Health Condition 1: L680- Hirsutism

• Registration Number: CTRI/2023/04/052032
• Lead Sponsor: Sami-Sabinsa Group Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-10-12
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 33

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified