Moderately severe wrinkles MedDRA version: 8.1 Level: LLT Classification code 10048042 Term: Wrinkles
Conditions
Interventions
Product Name: ICX-RHY-013
Product Code: ICX-RHY-013
Pharmaceutical Form: Suspension for injection
Current Sponsor code: Human dermal fibroblasts
Other descriptive name: Human dermal fibroblasts
Concen
Sponsors
Intercytex
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subjects who are healthy and male or female. - Subjects who are =18 - =50 years of age. - Subjects with mild (Grade 3) or moderate (Grade 4) nasolabial folds. - Subjects with symmetrical nasolabial folds. - Subjects with no clinically significant body weight changes in previous 6 months (>5kg weight change). - Subjects who have voluntarily signed and dated an Informed Consent Form (ICF). - Subjects, who are, in the opinion of the Investigator, able to understand the study, co-operate with the study procedures and are willing to return to the clinic for all the required follow-up visits. 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: - Subjects with no (Grade 1), minimal (Grade 2), severe (Grade 5) or very severe (Grade 6) nasolabial folds. - Subjects with previous use of injectable fillers into the nasolabial folds. - Subjects of afro-Caribbean origin. - Subjects with a known history of keloids. - Subjects with a know history of bleeding disorders. - Subjects with HIV therapy-associated lipodystrophy. - Subjects with active skin disease (e.g. cysts, infections, rashes, cancer/pre-cancer) in the nasolabial folds. - Subjects with a known allergy to any of the constituents of the product (appendix 3). - Subjects with known or suspected malignancy. - Subjects with a life expectancy of 40mg for more than 1 week, intranasal/inhaled steroids are acceptable) within 90 days of the first treatment or planning immunosuppressive therapy at any time during the study. - Subjects with known idiopathic or drug-associated coagulopathies. - Subjects taking medicinal products known to reduce haemostasis (e.g. heparin, coumarins, aspirin etc) in the 2 weeks prior to commencing treatment or planning to take medicinal products known to reduce haemostasis during the 28-day treatment phase. - Subjects who have taken any other investigational product within 90 days prior to screening or planned use of any other investigational product during the study period. - Subjects who are pregnant, planning pregnancy and women of child-bearing potential who are not abstinent or practising an acceptable means of contraception, as determined by the Investigator, for the duration of the treatment phase. - Subjects with abnormal blood biochemistry defined as 3 times that of the upper limit of the normal range and/or any other abnormal laboratory finding considered clinically significant. - Subjects with known alcohol or narcotic drug dependence.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Clinical efficacy analysis ;Secondary Objective: Safety, tolerability and histology analysis;Primary end point(s): • Clinical assessment of change in the severity grade of nasolabial folds (6-point photographic scale) at each visit except screening. • Volumetric assessment of nasolabial folds (3D facial imaging) at baseline, week 12 and week 24. • Investigator satisfaction (10-point visual analogue scale) at week 12 and week 24. • Subject satisfaction (10-point visual analogue scale) at weeks 12 and week 24. | — |
Countries
United Kingdom
Outcome results
None listed