Facial skin imperfections such as small scars, depressions, pock-marks and other localised contour deformities of healthy adults
Conditions
Interventions
Product Name: ICX-RHY-013
Product Code: ICX-RHY-013
Pharmaceutical Form: Suspension for injection
Current Sponsor code: Human dermal fibroblasts
Sponsors
Intercytex
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects who are healthy and male or female. 2. Subjects who are 18 - 55 years of age. 3. Subjects with discreet facial skin imperfection(s). 4. Subjects with no clinically significant body weight changes in previous 6 months (>5kg weight change). 5. Subjects who have voluntarily signed and dated an Informed Consent Form (ICF). 6. 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: 1. Subjects with previous use of injectable fillers into the facial skin imperfections. 2. Subjects with previous use of cellular therapy (e.g Isolagen). 3. Subjects of Afro-Caribbean origin. 4. Subjects with a known history of keloids. 5. Subjects with a know history of bleeding disorders. 6. Subjects with HIV therapy-associated lipodystrophy. 7. Subjects with active skin disease (e.g. cysts, infections, rashes, cancer/pre-cancer) in the facial skin imperfections. 8. Subjects with active skin infection including acne. 9. Subjects with a known allergy to any of the constituents of the product (appendix 3). 10. Subjects with known or suspected malignancy. 11. 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. 15. Subjects with known idiopathic or drug-associated coagulopathies. 16. Subjects taking medicinal products known to reduce haemostasis (e.g. heparin, coumarins etc) in the 2 weeks prior to commencing treatment or planning to take medicinal products known to reduce haemostasis during the 24 week study period. 17. 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. 18. 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. 19. 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. 20. Subjects with known alcohol or narcotic drug dependence.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Clinical efficacy analysis;Secondary Objective: Safety and tolerability analysis; Primary end point(s): Primary endpoints: • Clinical assessment of skin imperfections at each visit except screening, using digital photography • Investigator satisfaction (10-point visual analogue scale) at week 12 and 24 • Subject satisfaction (10-point visual analogue scale) at week 12 and 24 | — |
Countries
United Kingdom
Outcome results
None listed