Facial Hirsutism in Women
Conditions
Interventions
Trade Name: Vaniqa
Product Name: Vaniqa 11.5% Cream
Product Code: 1500-00
Pharmaceutical Form: Cream
INN or Proposed INN: Eflornitina hidrocloruro
Concentration unit: % (W/W) percent weight/weight
Con
Sponsors
Shire Pharmaceuticals Group plc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Female subjects aged between 18 and 85 2) Satisfactory medical assessment with no clinically significant and relevant abnormalities (of medical history or physical examination) 3) Clinical diagnosis of facial hirsutism/excessive facial hair 4) Customary frequency of removal of facial hair of two or more times per week 5) Presence of at least 20 terminal hairs on the upper lip and chin as determined by clinical observation 6) Skin type I-IV 7) Women of child bearing potential must agree to use an effective form of birth control for the duration of the study (stabilised on oral contraceptives for at least 3 months, abstinence, IUD, foam, condom or diaphragm 8) Negative pregnancy test 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Use of electrolysis, laser or depilation (waxing, EpiladyÒ, sugaring, etc) to remove hair within six weeks before the start of the 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. 2) Facial conditions such as severe inflammatory acne 3) Presence of significant scarring on the face 4) Use of topical medications on the face 5) History of skin malignancy 6) Connective tissue disorders 7) Current or recurrent disease that could affect the site of application, the action, absorption or disposition of the investigational medicinal product or clinical assessments 8) Current or relevant history of serious, sever or unstable (acute or progressive) physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures 9) Systemic or topical treatment with phenytoin, retinoids or corticosteroids 10) Female subjects who are pregnant or lactating, including females with a positive pregnancy test at screening 11) Previous topical use of eflornithine cream
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evauate the atrophogenic potential of twice daily application of eflornithine 11.5% cream in the treatment of women with excessive facial hair growth, by measuring change in total skin thickness of treated areas on the face from baseline as measured by ultrasound at 24 weeks compared to the placebo cream.;Secondary Objective: 1) To globally assess pre and post treatment skin biopsies for qualitative histological changes pertaining to photodamage and skin atrophy 2) To assess histological changes in the epidermis (thickness, architecture and cellular morphology) 3) To assess skin thickness as measured by ultrasound after 12 weeks treatment 4) To assess histological damage and histochemistry changes in the dermis (procollagen I formation and elastic tissue damage) 5) To assess efficacy using the Physician Global Assessment (PGA) and Subject Self Assessment Questionnaire (SSAQ) 6) To assess safety in terms of number and severity of adverse events;Primary end point(s): The primary endpoint will be the change in thickness of the treated facial skin (epidermis and dermis together) from baseline as measured by ultrasound evaluation at week 24. | — |
Countries
Spain
Outcome results
None listed