Health Condition 1: L680- Hirsutism
Conditions
Interventions
Intervention1: 1. ar – Turmerone Cream: 1 FTU (Finger Tip Unit) must be
applied twice a day for 90 days.
Control Intervention1: 2. Placebo: 1 FTU (Finger Tip Unit) must be
applied twice a day for 90 d
Sponsors
Sami-Sabinsa Group Ltd.
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • 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 ScoreTimepoint: Baseline, Month 1, Month 2 and Month 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| • 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.Timepoint: Baseline, Month 1, Month 2 and Month 3 | — |
Countries
India
Contacts
Public ContactMr Satish G
Sami-Sabinsa Group Limited
Outcome results
None listed