A Phase IIa Open-Label Dose-Escalation Pilot Study Using Allogeneic Human Dermal Fibroblasts for Nasolabial Folds
| Autor: | Philippa Lowe, Nicholas J. Lowe, John St Clair Roberts |
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| Rok vydání: | 2010 |
| Předmět: |
Adult
Male medicine.medical_specialty Pilot Projects Dermatology Cohort Studies Dermis medicine Dose escalation Humans Transplantation Homologous Adverse effect Acne business.industry Soft tissue General Medicine Fibroblasts medicine.disease Nasolabial fold Skin Aging Surgery Treatment Outcome medicine.anatomical_structure Patient Satisfaction Rhytidoplasty Dermal atrophy Female Open label business |
| Zdroj: | Dermatologic Surgery. 36:1578-1585 |
| ISSN: | 1076-0512 |
| DOI: | 10.1111/j.1524-4725.2010.01686.x |
| Popis: | BACKGROUND AND OBJECTIVE The correction of soft tissue contour defects and dermal atrophy is a growing area driven by medical and aesthetic need. Deterioration of the skin's appearance occurs as a result of age and trauma, such as surgery, infections, and acne. Typically, imperfections are treated with volume-correcting fillers. This study evaluated allogeneic human dermal fibroblasts (HDFs) for the treatment of nasolabial folds as an alternative strategy to improve the structure, texture, and quality of the skin. METHODS AND MATERIALS In this phase IIa study, a suspension of allogeneic HDF (2 × 106 cells/mL or 2 × 107 cells/mL) was injected intradermally along the nasolabial fold; line severity was assessed using a photographic scale. RESULTS Mean investigator satisfaction was 7.4 (range 4.7–9.5) at 12 weeks and 7.6 (range 4.4–9.8) at 24 weeks. Subject satisfaction scores were 7.0 (range 0.1–10.0) at 12 weeks and 7.8 (range 1.5–10.0) at 24 weeks. All patients experienced adverse events, the majority of which were deemed treatment related. Most were mild to moderate in severity and resolved completely. CONCLUSION This study demonstrated that allogeneic HDF can produce an improvement in aesthetic appearance with minimal adverse events and warrants further investigation and development. Intercytex provided financial support for this study. John Roberts is an employee of Intercytex. |
| Databáze: | OpenAIRE |
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