Renovo (United Kingdom)

Juvista™ drug product contains human recombinant active transforming growth factor beta 3 (TGFβ3; avotermin). Juvista is being developed for the prevention and reduction of human scarring. Phase II and III clinical and development batches of Juvista were assayed for content by an immunoenzymometric assay (IEMA) using a National Institute for Biological Standards and Control (NIBSC) TGFβ3 reference material (98/608) and avotermin standard (Lot 205-0505-005). Paired Juvista TGFβ3 data were compared directly, pooled, and processed using the statistical analysis described by Bland and Altman. A direct comparison of the two standards was also made. The Bland–Altman result was 1.958, the best estimate of the relationship between Lot 205-0505-005 and reference material 98/608. By IEMA, reference material 98/608 has approximately 50% of the immunoreactivity of Lot 205-0505-005. During clinical development, no change in Juvista TGFβ3 dosage was made, but the standard used for Juvista TGFβ3 assay was changed from 98/608 to 205-0505-005. The stated amount of Juvista TGFβ3 in phase III trials was approximately one-half of that in phase II trials. This article highlights the importance of early adoption of an appropriate and representative standard to achieve accurate quantification of protein drug during clinical development.

Few data are available regarding the psychological impact of scars arising from routine elective/aesthetic surgical procedures. To gain insight into both patients' and clinicians' concerns, the authors have undertaken structured semiquantitative surveys of (1) patients who had recently undergone a routine surgical procedure and (2) a cohort of plastic and aesthetic dermatological surgeons. All selected patients had undergone a surgical procedure within 6 to 24 months before survey and had a scar(s) that caused concern. Participants completed a previously validated Self Completion Form that aimed to investigate their concerns. Clinicians were surveyed via telephone interviews using a similar format of questionnaire but with questions tailored to clinicians. Ninety-seven patients and 24 clinicians were interviewed. Patients were dissatisfied with scars resulting from surgery, irrespective of gender, age, ethnicity, or geographical location, and 91 percent would value even small improvements in scarring. Patients had scar(s) that they wished were less noticeable over a wide range of body sites (both "visible" and "nonvisible"). Male and female respondents had similar rates of dissatisfaction about their own scars. The survey revealed issues in the communication between patients and clinicians regarding scars; 71 percent of patients felt that they were more concerned than their surgeon about the scar resulting from a recent surgical procedure. This preliminary study indicates that patients are highly concerned about scarring following routine surgery, with most patients valuing any improvement in scarring. These data also show that there are disparities in patient-clinician communication regarding expectations following surgery.

The natural history of scar maturation in humans has never been formally described from either a clinical or a histologic standpoint. The maturation of incisional scars was observed in 58 healthy male volunteers who each had 2 x 1-cm incisional wounds created on the inner aspect of both upper arms. The resulting scars were photographed digitally at monthly intervals for 12 months and excised for histologic analysis at specific time points. All histologic specimens were stained using Masson's trichrome and reviewed together with the corresponding digital clinical scar images to produce macroscopic and microscopic descriptions of the maturation process. Three distinct groups, each displaying a different rate of longitudinal progression of scar maturation, were identified from within the study group. The majority of volunteers belonged to a "representative" subset but distinct "poor" and "excellent" subsets were also identified. The poor subset invariably contained volunteers younger than 30 years of age, whereas the majority of the excellent subset comprised subjects older than 55 years of age. Scar maturation occurs as a series of defined macroscopic and microscopic stages over the course of 1 year. The rate of scar maturation varied within the study group, with older subjects (>55 years) displaying accelerated maturation, whereas a prolonged high turnover state and a retarded rate of maturation were observed in younger subjects (<30 years).

Anthropological studies suggest that prehistoric man used various techniques to close skin wounds (Ellis, 2001). The jaws of termites or beetles were used to bite across wounds and hold skin edges together in India and South America, and in East Africa acacia thorns were stuck along the two wound edges and then plaited together (Ellis, 2001). Suture materials used included horsehair, fibres from tree bark, cotton and, in ancient Rome, human hair and catgut (made from sheep's intestine) (Burnand and Young, 1998), which was used until recently in the UK. The sutures used in modern surgical practice are almost exclusively synthetic materials.

Wound healing usually results in a scar. No therapy currently exists for removing scars, so treatments focus on making them less obvious. Research is investigating how to prevent scars forming, inspired by what happens to foetuses in the womb.