TB-500 in cutaneous wound healing and tissue repair — evidence extract
The Institute's graded assessment of TB-500 for cutaneous wound healing and tissue repair, with the contributing trials and the domain-by-domain certainty reasoning.
§1Evidence extract: Cutaneous wound healing and tissue repair
§1.1Question and anchor outcome
- Population
- Restoration of epithelial and dermal integrity following injury, assessed by closure rate, area reduction and scar quality.
- Intervention
- TB-500, subcutaneous or intramuscular in research contexts
- Comparator
- As used in each contributing trial; reported per trial rather than pooled across comparator types
- Anchor outcome
- Time to complete closure
Additional outcomes the Institute extracts for this indication: Percentage area reduction; Scar assessment scale; Infection rate.
§1.2Contributing trials
Table 1. Trials contributing to the assessment of TB-500 in cutaneous wound healing and tissue repair.
| Trial | Phase | Design | Randomised | Duration | Year |
|---|---|---|---|---|---|
| TB4-PH2-EPIDERMOLYSIS | 2 | Randomised, double-blind, placebo-controlled | 30 | 12 weeks | 2016 |
| TB4-PH2-DRYEYE | 2 | Randomised, double-blind, placebo-controlled | 72 | 4 weeks | 2015 |
§1.3Certainty assessment
Table 2. Reasoning recorded against each certainty domain.
| Domain | Rating | Reasoning |
|---|---|---|
| Risk of bias | No concern | No serious concern identified in this domain. |
| Inconsistency | No concern | No serious concern identified in this domain. |
| Indirectness | No concern | No serious concern identified in this domain. |
| Imprecision | Serious | A single small trial contributes the whole estimate. |
| Publication bias | Very serious | Registered trials without posted results were identified for this question. |
| Overall rating: Very low certainty. The Institute has very little confidence in the effect estimate. The true effect is likely to be substantially different from the estimate. In this series a very low rating most often reflects an absence of controlled human evidence rather than conflicting evidence. | ||
§1.4What this extract does not establish
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- Goldstein AL, Hannappel E, Sosne G, Kleinman HK. Thymosin β4: a multi-functional regenerative peptide. Basic properties and clinical applications. Expert Opinion on Biological Therapy 2012;12(1):37–51. doi:10.1517/14712598.2012.634793 · PMID 22074294
- Thevis M, Thomas A, Schänzer W. Detecting peptidic drugs, drug candidates and analogs in sports doping: current status and future directions. Expert Review of Proteomics 2019;11(6):663–673. doi:10.1586/14789450.2014.965158
- D’Hondt M, Bracke N, Taevernier L, Gevaert B, Verbeke F, Wynendaele E, De Spiegeleer B. Related impurities in peptide medicines. Journal of Pharmaceutical and Biomedical Analysis 2014;101:2–30. doi:10.1016/j.jpba.2014.06.012 · PMID 25044089
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.