A phase IIa open-label dose-escalation study using ICX-RHY to enhance the aesthetic appearance of nasolabial folds - RHY IIa

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 16

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

- 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 <9 months, terminal conditions or factors making follow-up difficult (e.g. no fixed address, telephone etc).
- Subjects with an intolerance to additional study-associated drugs/therapies (e.g. isopropyl alcohol, EMLA cream, adrenaline, lignocaine etc).
- Subjects with planned major surgical intervention during the course of the study.
- Subjects taking immunosuppressive therapy including systemic steroids (i.e., oral prednisolone >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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>• Volumetric assessment of nasolabial folds (3D facial imaging) at baseline, week 12 and week 24.<br>• Investigator satisfaction (10-point visual analogue scale) at week 12 and week 24.<br>• Subject satisfaction (10-point visual analogue scale) at weeks 12 and week 24.<br>

Secondary Outcome Measures