Excessive facial hair in females (Facial hirsutism) MedDRA version: 8.1 Level: LLT Classification code 10020112 Term: Hirsutism
Conditions
Interventions
Trade Name: Vaniqa 11.5% Cream
Pharmaceutical Form: Cream
INN or Proposed INN: Eflornithine 115mg
CAS Number: 96020-91-6
Other descriptive name: hydrochloride monohydrate
Concentration unit: mg millig
Sponsors
Shire Pharmaceutical Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Female subjects aged 18 or over - Satisfactory medical assessment with no clinically significant and relevant abnormalities (of medical history or physical exam) - Clinical diagnosis of facial hirsutism/excessive facial hair - Subjects with Fitzpatrick skin type I- IV - For effective photoepilation skin/hair contrast must be adequate (hair in target areas to be predominantly brown or black in colour) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Use of electrolysis or epilation (plucking, waxing, Epilady, sugaring etc.) to remove hair within 6 weeks before start of study or regular use of any other medication that could affect (improve or worsen) the condition being studied, or could affect the action, absorption or disposition of the investigational product or clinical assessments - Use of laser to remove hair within 6 months before start of study - Facial conditions such as severe inflammatory acne - Use of systemic antiandrogens, growth hormone, insulin-sensitising agents, spironolactone, immunostimulants, immunosuppressants, dehydroepiandosterone (DHEA), minoxidil, flutamide or other medications considered to have an effect on hair growth with 6 months of the study - Change of oral contraceptive with 6 months prior to screening - Use of concomitant therapy with any medication considered to exacerbate or be useful treatment of hirsutism including ketoconazole. Cyproterone acetate use is allowed up to a maximum dose of 2mg per day. - Presence of significant scarring, haemangioma, melanocytic naevi or any other abnormalities in the Trichoscan reference area - Hepatic/ renal impairment - History of skin malignancy - A history of androgen secreting tumour - A known severe hyperandrogenaemia or hormonal imbalance requiring or likely to require systemic treatment during the course of the study - Female subjects who are pregnant or lactating, including females with a positive pregnancy test at screening - Subjects must not have used any other investigational product or taken part in a clinical trial within the last 30 days prior to randomisation - Known or suspected intolerance or hypersensitivity to the investigational products or any stated ingredients - Systemic or topical treatment with phenytoin, retinoids, ciclosporin or corticosteroids - Current or recurrent disease that could affect the site of application, the action, absorption or disposition of the investigational product or clinical asessments - Patients will not be permitted to use plucking as a method to remove facial hair for the duration of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of twice-daily application of eflornithine 11.5% cream with laser treatment in the treatment of women with excessive facial hair growth on upper lip and chin, by measuring cumulative length of hair (total length of all visulised hairs added together) within a pre-defined area of the upper lip. It will be measured by using digital image analysis (Trichoscan), and compared to a contol group receiving laser treatment alone.;Secondary Objective: - To evaluate efficacy by measuring mean hair thickness on upper lip, as measured by digital image analysis (Trichoscan). - To evaluate efficacy by measuring mean growth rate of hair on upper lip, as measured by digital image analysis (Trichoscan) - To evaluate efficacy by blinded central assessment of a photographic image of the lower face. - To evaluate overall subject satisfaction using a subject self-assessment questionnaire. - To evaluate safety by recording adverse events.;Primary end point(s): To evaluate the efficacy of twice-daily application of eflornithine 11.5% cream with laser treatment in the treatment of women with excessive facial hair growth on upper lip and chin, by measuring cumulative length of hair (total length of all visulised hairs added together) within a pre-defined area of the upper lip. It will be measured by using digital image analysis (Trichoscan), and compared to a contol group receiving laser treatment alone | — |
Countries
Austria
Outcome results
None listed