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

Completed

• Conditions: Hirsutism,

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

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-29
• Study Completion: 2023-12-10
• Last Update Posted: 2023-12-22

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 34

Inclusion Criteria

• Subjects who are suffering from PCOD/PCOS.
• Subjects willing to participate in the trial.
• 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.
• 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.
• Subjects agreeing to use the provided investigational product provided during the study.
• Subjects willing and able to fulfill the study requirements and schedule.
• Subjects willing to avoid oily, greasy, junk food and high-sugar food items, as much as possible during the study period.
• 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.
• 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).
• Subjects must agree to remove all jewelry on/around face (e.g., necklace, earrings, if possible, nose ring), during Digital imaging.
• Subjects willing to abide by and comply with the study protocol.
• Subjects must not have participated in a similar investigation in past four weeks.
• 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.
• 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.
• Women with Cushing syndrome and CAH as per the medical examination and blood test report.
• Subjects having severe illness like hypertension, ovarian cancer or any other form of malignancy, thyroid dysfunction.
• Women who are having hypertrichosis.
• 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.
• Subject who is under the treatment/care of a dermatologist/ gynecologist.
• History of allergies, hypersensitivity or any serious reactions to any cosmetic products.
• Any significant skin pathology in the test areas, like rosacea, or eczema.
• Any significant medical condition that would interfere with the participation in the study, as per the opinion of the Investigator.
• 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.
• Any dermatological procedure on the test areas (laser peel, dermabrasion etc.) taken 4 weeks before the start of the study and during the study.
• Having participated in the last 30 days before screening or currently participating in another clinical study.
• Unable to be contacted by phone in case of emergency.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
• Significant reduction in the following	Baseline, Month 1, Month 2 and Month 3
parameters based on Trichoscan Image	Baseline, Month 1, Month 2 and Month 3
Analysis:	Baseline, Month 1, Month 2 and Month 3
a. Facial Hair Density (n per cm2) on Months 1,	Baseline, Month 1, Month 2 and Month 3
2 and 3 in comparison to Baseline.	Baseline, Month 1, Month 2 and Month 3
b. Facial Hair Diameter (?m) on Months 1, 2 and	Baseline, Month 1, Month 2 and Month 3
3 in comparison to Baseline	Baseline, Month 1, Month 2 and Month 3
c. Facial Hair Growth Rate (mm per day) on	Baseline, Month 1, Month 2 and Month 3
parameters based on Dermatological Visual	Baseline, Month 1, Month 2 and Month 3
Assessment:	Baseline, Month 1, Month 2 and Month 3
a. Modified Ferriman-Gallwey Score	Baseline, Month 1, Month 2 and Month 3
Months 1, 2 and 3 in comparison to Baseline	Baseline, Month 1, Month 2 and Month 3

Secondary Outcome Measures

Name	Time	Method
• Significant reduction in Hirsutism Score as	assessed by the Modified Ferriman-Gallwey

Trial Locations

Locations (1)

MS Clinical Research; 🇮🇳 Bangalore, KARNATAKA, India

MS Clinical Research

🇮🇳Bangalore, KARNATAKA, India

Dr Mukta Sachdev

Principal investigator

08041125934

mukta.sachdev@msclinical.com