Efficacy of Compound GV-350 with Tricofer® Iron, Cystine and Biotin in the Management of Telogen Effluvium in Women with Iron Deficiency

Objective: Iron deficiency without anaemia can induce Telogen Effluvium (TE). Traditional oral iron salts are poorly and erratically absorbed. The present study investigated whether treatment with GV-350 (30 mg Tricofer®, 500 mg cystine, 250 µg biotin daily) on an empty stomach for 3 months improved iron status and TE in 20 iron- deficient women (ferritin <40 ng/mL). Methods: Blood tests to measure iron status were performed. Safety (adverse events), impact of the TE in the quality of life (Hair-Specific Skindex-29 score; HSS-29) and percentage of surface covered by hair before and after treatment (photographs, N=8) or phototrichogram (N=3) were also measured. Dermatologists and patients provided a global assessment of the efficacy and tolerability of GV-350. Results: After 3 months of treatment, iron status improved significantly with increases in serum iron (68.7 ± 18.4 to 83.9 ± 25.2 µg/dL; p<0.05), ferritin (26.1 ± 11.2 to 43.8 ± 40.5 ng/mL; p=0.025), transferrin saturation index (TSI; 21.8 ± 6.2 to 31.3 ± 7.9 %; N=14, p<0.01), red blood cells (4.2 ± 0.2 to 4.3 ± 0.2 x10⁶/µL; p<0.025) and haemoglobin (12.9 ± 0.7 to 13.1 ± 0.8 g/dL; p=0.053). This was accompanied by an improvement in the results of the phototrichogram, hair surface area and satisfaction (efficacy and tolerability). Impact of TE in overall quality of life was reduced by 53% (vs. baseline), but also in its three dimensions: emotional, functional and symptomatic. There were no treatment-related adverse events. Conclusion: We conclude that compound GV-350 taken on an empty stomach for 3 months is adequately absorbed, improving iron deficiency, the clinical symptoms of TE and the quality of life of patients, with good tolerability.