LL-37 in cutaneous wound healing and tissue repair — evidence extract
The Institute's graded assessment of LL-37 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
- LL-37, topical and intralesional in clinical studies
- 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 LL-37 in cutaneous wound healing and tissue repair.
| Trial | Phase | Design | Randomised | Duration | Year |
|---|---|---|---|---|---|
| LL37-PH1-2-VENOUSULCER | 1/2 | Randomised, double-blind, placebo-controlled | 34 | 4 weeks | 2014 |
§1.3Certainty assessment
Table 2. Reasoning recorded against each certainty domain.
| Domain | Rating | Reasoning |
|---|---|---|
| Risk of bias | Serious | Allocation concealment is not described in one contributing report. |
| Inconsistency | Serious | Estimates vary in magnitude across contributing trials beyond what chance would produce. |
| Indirectness | No concern | No serious concern identified in this domain. |
| Imprecision | No concern | No serious concern identified in this domain. |
| Publication bias | No concern | No serious concern identified in this domain. |
| Overall rating: Low certainty. Confidence in the effect estimate is limited. The true effect may be substantially different from the estimate. | ||
§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.
- 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
- Manning MC, Chou DK, Murphy BM, Payne RW, Katayama DS. Stability of protein pharmaceuticals: an update. Pharmaceutical Research 2010;27(4):544–575. doi:10.1007/s11095-009-0045-6 · PMID 20143256
- Wang W, Nema S, Teagarden D. Protein aggregation — pathways and influencing factors. International Journal of Pharmaceutics 2010;390(2):89–99. doi:10.1016/j.ijpharm.2010.02.025 · PMID 20188795
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.