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

Maria Blanco de Tord¹, Enrique Gargallo Santa-Eulalia², Almudena Nuño González³, María José García Hernández⁴, Rubén del Río Gil⁵, Ramón Grimalt Santacana⁶, Cristina Serrano Falcón^7*

¹Instituto Epidermos. Dermatologia y Estética, Barcelona, Spain
²Clínica Medinorte, Valencia, Spain
³Instituto de Medicina y Dermatologia Avanzada (IMDA), Madrid, Spain
⁴Clinica Dermofit. Sevilla, Spain
⁵Fundació Hospital de l´Esperit Sant, Santa Coloma de Gramenet (Barcelona), Spain
⁶Department of Dermatology, Faculty of Medicine and Health Sciences, Universitat Internacional de Catalunya, Barcelona, Spain
⁷Clínica Dermatológica Serrano, Granada, Spain

*Correspondence author: Cristina Serrano Falcón, Clínica Dermatológica Serrano, Granada, Spain;
Email: [email protected]

Citation: Tord MBD, et al. Efficacy of Compound GV-350 with Tricofer® Iron, Cystine and Biotin in the Management of Telogen Effluvium in Women with Iron Deficiency. J Dermatol Res. 2025;6(3):1-9.

Copyright^© 2025 by Tord MBD, et al. All rights reserved. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Table 1: Patient characteristics.

Evolution of Iron Metabolism Parameters

Serum iron levels increased from a mean 68.7 ± 18.4 μg/dL to 83.9 ± 25.2 μg/dL (N=20; p<0.05). The mean basal ferritin also increased after treatment with GV-350 from 26.1 ± 11.2 ng/mL to 43.8 ± 40.5 ng/mL (N=20; p<0.05). Transferrin Saturation Index (TSI (%)) was measured in 14 of the 20 cases, with mean values from 21.8 ± 6.2% at baseline augmented to 31.3 ± 7.9% at the end of treatment (N=14; p<0.01). The number of red blood cell at baseline was of 4.2 ± 0.2 x10⁶/μL and changed to 4.3 ± 0.2×10⁶/μL after 3 months of treatment (N=20; p<0.05). Haemoglobin baseline levels were of 12.9 ± 0.7 g/dL and increased to 13.1 ± 0.8 g/dL at the final control (N=20; p-paired=0.053). The results of the iron metabolism parameters are summarized in Table 2, Fig. 1.

Table 2: Evolution of the analytical parameters of iron status in blood.

Figure 1: Boxplot of the evolution of serum iron, ferritin and Transferrin Saturation Index (IST), before (white) and after 3 months of treatment with GV-350 (grey). A p<0.05 was considered statistically significant.

Evolution of the Hair Specific Skindex-29 Quality of Life Scale

The impact of TE on patients’ quality of life was evaluated by applying the 29-item Hair- Specific Skindex scale (HSS-29). The patients showed different degrees of impairment of quality of life as a result of TE. Table 3 and Fig. 2 summarize the mean values obtained before and at the end of treatment, both globally and for each separate dimension. All the means improved with respect to the baseline visit, going from moderate to no affectation in the emotional and symptomatic dimensions and from mild to no affectation for the functional dimension and the patient’s global assessment. These improvements at the end of treatment were statistically very significant.

Table 3: Evolution of the impact of TE on patients’ quality of life (Hair Specific Skindex-29 score), before and at the end of treatment.

Figure 2: Boxplot of the Evolution of the impact of TE on patients’ quality of life (Hair Specific Skindex score-29; HSS), before (white) and at the end of treatment (grey), both global assessment and functional, emotional and symptomatic dimensions.

Phototrichogram Results

This test was performed on only 3 of the 20 patients, therefore no statistical conclusions can be drawn. However, it should be noted that all the parameters assessed improved in all 3 cases, as shown in Table 4. The mean hair density increased by 11.9% compared to baseline. This increase is confirmed by the 18% rise in the average of terminal hairs and the 5.6% decrease in the average vellum, which gives an increase in the ratio of terminal hairs to vellum of 19.4%.

Table 4: Evolution of the parameters measured with a phototrichogram.

Photographs and Percentage of Surface Covered by Hair

Photographs were taken in 8 of the 20 patients, before and after treatment and the percentage of surface covered by hair was calculated. The results indicate that this percentage increased from 50.7 ± 11.8% to 54.3 ± 11.5%. This represents a relative increase of 7.1% compared to the baseline mean. The t-test for means of two paired samples showed that the increase was statistically very significant (N=8; p=0.0025) (Fig. 3).

Figure 3: Photographs of a representative case, (A) before and (B) after treatment with GV-350. (C) Boxplot of the surface covered by hair in photographs from 8 patients, before (white) and at the end of treatment (grey).

Global Assessments of Investigators and Patients

In relation to efficacy (Fig. 4), the researchers considered it good in all patients (100%, N=19), while 95% (N=18) of the patients considered it good and 5% (N=1)) fair. One case did not answer this question. The Chi-square test confirmed that the responses did not show statistically significant differences (p=0.598) between physicians and patients. Regarding tolerability (Fig. 4), the opinions were repeated: 100% of the patients (N=20) presented good tolerability to GV-350 according to the physicians, while 95% (N=19) of the patients considered it good and 5% (N=1)) fair. Again, the Chi-square test confirmed that the responses of physicians and patients did not show statistically significant differences (p=0.599) between them.

Figure 4: Bar graph summarizing physicians’ and patients’ global assessments about the efficacy and tolerability of GV-350. Data expressed as a percentage of cases with respect to the total.

Adverse Events

During the study, a case of mononucleosis was recorded, whose relationship with the treatment under study was considered by the researcher to be remote. No other events or adverse reactions were recorded during the test.

Adherence to Treatment

Adherence to treatment was considered good if more than 80% of treatment was completed. With the exception of two patients who stopped taking 25 and 30 of the 180 capsules that completed the treatment (86% and 83% adherence, respectively), all other patients in the study completed the therapy adequately. The two patients were also included in the final statistical analysis, exceeding the 80% threshold.

Discussion

Iron participates as a regulator of hair follicle activity (proliferation, energy metabolism, follicle oxygenation, growth). Low iron availability in the hair follicle in the event of a decrease in circulating iron, as occurs in iron deficiency or anaemia, can induce Telogen Effluvium (TE) (Deloche 2007, Elston 2010, Cranwell 2019). Traditional oral iron salts are poorly and erratically absorbed. We hypothesized that iron supplementation with Tricofer® (30 mg iron element/day) together with the L-cystine (500mg/day) and biotin (250μg/day) of the GV-350 compound, would improve the TE of female patients with baseline ferritin below 40 ng/mL. Our present study has shown that GV-350 is effective and safe in the oral management of these women, improving the initially altered iron metabolism parameters, while producing a clinical improvement in their effluvium as demonstrated in the cases studied by phototrichogram and the surface covered with hair. This was supported by the patient’s global assessments on the GV-350 efficacy and tolerability. Moreover, the impact of TE in the quality of life of these women assessed with the Hair Specific Skindex-29 scale was reduced.

Diffuse alopecia is characterized by a reduction of follicles in the anagen phase and an increase of hair in the telogen phase, presence of miniaturized hairs and reduced hair density over time (Rushton 1990). There is evidence that pre-menopause women with androgenetic alopecia, Telogen Effluvium (TE) and alopecia areata, had statistically significant lower iron deposits than women of the same age without alopecia (Kantor 2003). Between 20 to 25% of women with TE have iron deficiency in the absence of anaemia, with ferritin levels below 40ng/mL (Rushton 1990, Rushton 1992, Rushton 2002a, Deloche 2007, De Viragh 2013). Several studies coincide that levels below this threshold can trigger the hair to enter the telogen phase. Under the study conditions, our results in the evolution of the iron status have been very favourable, since all the analytical parameters have improved significantly. Particularly relevant were the increases with respect to the baseline mean in serum ferritin levels (68%), serum iron levels (22%) and in the transferrin saturation index (44%). Rushton and cols already published that iron supplementation rises ferritin levels above 40 ng/mL, improves hair quality, increases the percentage of hairs in the anagen phase and decreases that in telogen phase, resulting in more hair density (Rushton 2002b, Trost 2006, Lin 2023). They also published that iron supplementation may favour the response to other specific treatments for alopecia (Rushton 1992). We did not include other treatments for alopecia, however the trichogenic benefits of supplementation with biotin and cystine, are well known. The hair shaft is composed almost entirely of protein (primarily keratin). Keratin has a high cystine content; and its structure resilience increases with the amount of cystine. The involvement of biotin in protein synthesis and more specifically, in keratin production, explains its contribution to healthy nail and hair growth; more evident in patients with biotin deficiency such as pregnancy, malnutrition, medication effects and biotinidase deficiency (Patel 2017, Galmes 2023). In the present study, although it was only measured in 3 patients, hair density improved by 12% and the number of terminal hairs by 18%, increasing the ratio of terminal hairs to vellum by 19%. In the same way, the photographic assessment of the surface covered by hair carried out in another 8 patients showed a significant increase of 7.1%. TE has cosmetic implications that can impact negatively in the quality of life of patients. For this reason, it is even recommended to address the need to use psychological tests in the field of dermatology (Costeris 2021). To assess the impact of TE hair loss in quality of life of our patients we used the validated 29-item Hair-Specific Skindex questionnaire. This questionnaire not only assesses the global impact, but also different dimensions that focus on functional questions (social life, isolation, sexuality, work, hobbies), emotional items (embarrassment, annoyance, depression, frustration) and a symptomatic dimension (itching, pain, irritation). The scale allows stratifying the degree of affectation in quality of life. In our study we observe that the favourable analytical results and the clinical improvement of the effluvium have impacted positively in the evolution of the quality of life. All the means improved with respect to the baseline visit, decreasing from moderate to no affectation in the emotional and symptomatic dimensions and from mild to no impact for the functional dimension and the patient’s global assessment. The Hair- Specific Skindex-29 score, was statistically significant reduced by 53% with respect to the basal, minimizing the impact of alopecia after three months of treatment. Traditional iron salts are usually associated with adverse gastrointestinal symptoms such as diarrhoea, constipation, nausea, stool coloration, etc.), that result in a poor adherence to treatment (Cancelo-Hidalgo 2013, Pantopoulos 2024, Dhanvijay 2025). The absorption of oral iron is low and erratic, depending on different factors such as the iron status itself, its intake or not on an empty stomach, the iron salt used, the presence of alteration in the intestinal mucosa, etc. To ensure the adequate absorption of the iron in the GV-350 compound, a trivalent liposomal salt, Tricofer®, has been used. It has a lipid envelope that facilitates intestinal absorption, while protecting the salt from direct contact with the mucosa, improving its tolerability. On the other hand, to avoid the possible interaction of food in its absorption, patients were asked to ingest the capsules on an empty stomach. Our data demonstrates that GV-350 product is well tolerated, as indicated by practically all patients, even when ingested on an empty stomach, which confirms the protection of Tricofer® and this has contributed to the adequate adherence of patients during the 3 months of treatment. Furthermore, no adverse reactions were recorded associated with the study treatment. This contributed to complete treatment with acceptable adherence in all cases.

This research has some limitations. As it is a single-arm study, participants act as their own controls, making it difficult to establish causality. Besides, TE is usually self- limiting, even though the recovery process can take many months. The median duration of TE in our cases was of 7 months (IQR: 6-13.5 months). In our study, ferritin levels were confirmed and treatment with GV-350 was performed, the clinical setting of TE improved significantly in the final control visit. Despite the duration of the TE and treatment with iron for only 3 months, the possibility of a spontaneous resolution cannot be disregarded. Another limitation is the small sample size and few cases with evidence on the clinical evolution of the TE. The selection criteria were strict, which, despite telogen effluvium being a common condition, made participant inclusion difficult and justifies the final number of subjects. However, we consider it adequate for a preliminary exploratory study. The main objective of this study was to demonstrate whether the GV- 350 compound could improve the iron status on an empty stomach, however, photographs or phototrichogram were only performed by some researchers. Taking this present data as preliminary, a future Randomized Controlled Trial (RCT) should be conducted for confirmatory evidence. Finally, even though quality-of-life improvement is significant, psychosocial confounding factors (placebo response, natural remission of TE) should be acknowledged. Regarding limitations, we note that many are shared with other studies on TE, especially considering its potentially self-resolving nature when a specific cause is present. However, in this study, which focuses on effluvium associated with low ferritin levels, we have an objective measure -ferritin- that showed improvement, which has a direct and close relationship with the pathophysiology of effluvium.

Conclusion

The results of this study show that the GV-350 compound at the dose of 30 mg of Tricofer®, 500 mg of L-cystine and 250μg of biotin per day, ingested on an empty stomach for 3 months, is effective in the treatment of chronic telogen effluvium in iron deficiency (non-anemic) women, improving iron status, clinical signs of TE and patients’ quality of life, with a very good tolerability and safety profile.

Conflicts of Interest

This research was sponsored by Laboratorios Viñas, S.A; which complies with the Good Practice Code for the Pharmaceutical Industry (Farmaindustria Code). Dr. Irene Lopez- Vilchez, Dr. Cleofé Zaragozá and José Luis Galmés Olmos, from the Clinical Research Department of Laboratorios Viñas prepared the study design and participated in the study monitorisation. They performed the transcription of the CRF data into the database and made the statistical analysis. Based on the final study report that contained the raw data attached for transparency, prepared the manuscript draft to be critically reviewed by the authors.

Funding

This research was sponsored by Laboratorios Viñas, S.A.

Acknowledgements

None.

Informed Consent Statement

Informed consent was obtained from the participants involved in this study.

Authors’ Contributions

RGS participated in the preparation of the study design. The rest of the authors participated in the inclusion of cases and data collection according to the study protocol. RdRG provided Phototrichogram results in his 3 cases. MBdT and ANG provided pictures for the assessment of surface covered with hair in their 8 cases. All authors performed a critical review of the manuscript. All authors provided their final approval of the version to be published. Authors agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

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