Abstract

Objectives: We sought to assess the compliance, efficacy, and safety of Heterologous Type I Collagen (HTIC) intradermal injections in female and male patients with biopsy-proven activegenital lichen sclerosus, who had shown limited response to topical steroid treatment. Introduction: Genital Lichen Sclerosus (GLSc) is a chronic, progressive, inflammatory dermatosis predominantly affecting genital mucous membranes in both sexes. Advanced GLSc significantly impacts patients' quality of life and escalates the risk of squamous cell carcinoma in genital regions. Currently, there is no definitive cure or universally effective treatment for GLSc. Materials / method: In this study, we evaluated the compliance, efficacy, and safety of Heterologous Type I Collagen (HTIC) intradermal injections in nine patients (six females and three males) with biopsy-proven active GLSc, who had shown limited responsiveness to topical steroid treatment. Each patient received four treatments at two-week intervals. Results: Remarkably, all patients experienced a reduction in lesion size after the first treatment, with complete resolution observed after either the third (five females and two males) or fourth (one female and one male) treatment. Additionally, pruritus, soreness, discomfort, and dyspareunia significantly improved, with complete resolution after the second treatment. Importantly, patients remained symptom-free and did not experience relapses during a 24-month follow-up period with minimal maintenance treatment. Conclusion: HTIC demonstrates promise as a novel treatment approach for GLSc, deserving further exploration through rigorous randomized controlled trials.