The first Phase II clinical trial, focused on nasolabial folds, was conducted at the Cranley Clinic for Dermatology in London. In this trial six subjects received a low dose of product. A second group of 10 subjects was then injected with a higher dose.
All subjects were followed out to six months post-treatment and the average satisfaction scores for both groups at six months for the treatment as assessed separately by both subjects and the investigator on a scale of 1-10 (10 being the highest), were 7.8 and 7.6 respectively. In addition, the investigator measured an improvement in wrinkle severity in 12 (75%) subjects. No serious adverse events have been observed and the product has been well tolerated.
The second Phase II study involved the use of the product in acne scarring in a study conducted at the MediZen Clinic in Birmingham. Subjects were followed out to six months post-treatment and the average satisfaction scores for the treatment at six months as assessed separately by both subjects and the investigator on a scale of 1 -10 (10 being the highest) were 6.8 and 6.3 respectively. No serious adverse events have been observed and the product has been well tolerated.
Treatment has commenced in a third Phase II trial investigating use of the product for burns scars (including contractures). It is intended to recruit up to 30 patients in this open label study.