Research & Studies

Thymuskin's research focuses on the scientific study of the patented GKL-02 Thymic Peptide Complex, as well as clinical and preclinical studies on Thymuskin and hair loss.

Contents

Clinical Trials

Androgenetic Alopecia

A multicenter study8 investigated the efficacy and tolerability of Thymuskin (serum and shampoo) in the early stages of androgenetic alopecia (AGA) and in cases of chronic telogen effluvium (chronic TE) over a period of 6 months. The study included 364 participants, who were divided into the following groups:

  • 70 men (average age 30.7 years) with AGA
  • 57 men (average age 35.9 years) with chronic TE
  • 53 women (average age 42.1 years) with AGA
  • 184 women (average age 36.9 years) with chronic TE

Over a total period of 24 weeks, the patients applied the serum once daily and the shampoo three times a week. For all participants, the investigator performed a pull test and an evaluation of symptoms (seborrhea, erythema, and itching). Tolerability as well as cosmetic acceptance/tolerance were also assessed. In both patients with AGA and those with chronic TE, after 6 months of treatment, there was a significant reduction in hair loss, stimulation of hair growth, and a reduction in the symptoms of seborrhea, erythema, and itching. Tolerability and cosmetic acceptance were good to very good in the majority of patients.

In summary:

  • Reduction in hair loss in an average of 96% of patients
  • Improvement in seborrhea and erythema in at least 89% of patients in each case
  • Elimination of itching in 74% of women and 75% of men

Chronic telogen effluvium

A multicenter study8 evaluated the efficacy and tolerability of Thymuskin (serum and shampoo) in 184 women and 57 men with chronic telogen effluvium (chronic TE) over a period of 6 months.

Reduction in Hair Loss8

  • 99% (182/184) of the women and 98% (56/57) of the men showed improvement on the pull test

Improvement in Seborrhea and Erythema8

  • Improvement in seborrhea and erythema in 93% and 97% of women, respectively
  • Improvement in seborrhea and erythema in 79% and 76% of men, respectively

Relief from itching8

  • Itching was eliminated in 80% (92/115) of women; in 17% (20/115), itching was still mild, and in 3% (3/115), it was still moderate
  • Itch was eliminated in 51% (21/41) of men; in 39% (16/41), itch was still mild, and in 10% (4/41), it was still moderate
  • Severe itch was completely eliminated in 16 women
  • Severe itching was completely eliminated in 9 men

In summary:

  • Hair loss was reduced in an average of 99% of patients
  • Seborrhea and erythema improved in at least 93% of women and 76% of men, respectively
  • Itching was eliminated in 80% of women and 51% of men

In the aforementioned multicenter study8, tolerability and cosmetic acceptance were additionally assessed in patients with androgenetic alopecia as well as in patients with chronic telogen effluvium.

  • Tolerability was very good in 50% of patients and good in 43%
  • No side effects were observed that led to discontinuation of treatment
  • Cosmetic acceptance was very good in 45% of patients, good in 43%, adequate in 10%, and poor in 2%

Preclinical Research

Increasing the Cell Vitality of Keratinocytes

Thymuskin was tested using the EpiDerm® model. The test tissue consists of a multilayered culture of human keratinocytes. Under the laboratory conditions studied, a 10% Thymuskin solution led to increased vitality in the test tissue. The observed effect increased with concentration and duration of exposure.

Studies on the potential impact on mast cell activity

Mast cells play a role in the transition of hair into the shedding phase and influence the activity of the hair follicle, thereby affecting hair growth in various ways. This appears to be particularly relevant in the case of stress-induced hair loss.4

As part of the preclinical Thymuskin research, it was therefore investigated whether components of the active ingredient complex can interact with serine proteases released from mast cells.

Good skin penetration

In vitro penetration studies on human scalp and abdominal skin have shown that approximately 45% of a 0.1% solution of Thymuskin penetrates deep enough into the skin. The majority of the active ingredient in Thymuskin reaches the hair follicle through the hair shaft.

The in vitro study thus demonstrates that components of the active ingredient complex under investigation can reach deeper layers of the skin and the area around the hair follicle following topical application.7

Additional historical clinical studies

The studies listed below document historical research on earlier thymuskin preparations and are included here solely to illustrate the history of the research.

Alopecia areata

Thymu-Skin: A New Therapeutic Approach for the Treatment of Androgenetic Alopecia and Alopecia Areata.9Der Deutsche Dermatologe 39, Issue 7 (1991). Conducted at the Dermatology Clinic of the Darmstadt Municipal Hospitals, an academic teaching hospital affiliated with the Universities of Frankfurt and Heidelberg, by K. Mössler.

Topical therapy with thymus extract for alopecia areata totalis sive universalis.10 Reprint from “Der Deutsche Dermatologe” 11/1993, pp. 1175–1182. ) Conducted at the Dermatology Clinic of the Darmstadt Municipal Hospitals, an academic teaching hospital of the Universities of Frankfurt and Heidelberg, by K. Mössler and M. Hagedorn:

Alopecia caused by cytostatic drugs

Summary Report on the Adjuvant Local Application of Thymu-Skin Preparations in Patients Undergoing Cytostatic Chemotherapy.11 Reprint from: Deutsche Zeitschrift für Onkologie 1/90. Multicenter study conducted at the University of Münster, the Medical Academy of Hanover, and the First Department of Internal Medicine at the Klinikum rechts der Isar of the Technical University of Munich (1988), Lüpke N.-P.

Variations in Head Hair Preservation During Chemotherapy with Different Drugs.12 Conducted at the German Cancer Research Center, Heidelberg, Department of Medical and Biological Informatics, Köhler C. O.:

Report on the study regarding the use of Thymuskin shampoo and treatment regimen in patients undergoing chemotherapy,13 conducted at the Ludwig Boltzmann Institute for Clinical Oncology at the Vienna-Lainz City Hospital. May 29, 1989, Denck H., Wallner M.

Bibliography

  • 1. Maurer H. R.: Preclinical Investigation of Thymic Preparations GKL-01, GKL-02; Internal Research Report, 2005
  • 2. NeuroBiotec: Studies on the Dermal Irritation of GKL-02 Using the EpiDerm® Model; Internal Research Report, 2005
  • 3. Maurer M. et al.: Activated skin mast cells are involved in murine hair follicle regression (catagen). Lab. Invest. 77 (4), 319–332, 1997
  • 4. Peters E.M.J. et al. Hair growth inhibition by psychoemotional stress: a mouse model for neural mechanisms in hair growth control. Experimental Dermatology 2006: 15: 1–13
  • 5. Birr C.: Development of a Bioassay for the Quality Control of the Drug Substance GKL-02 by Biological Means 2005
  • 6. Journal of Investigative Dermatology, Online Advance Publication, March 8, 2012; doi:10.1038/jid.2012.2
  • 7. PhaCos: Pharmacokinetic Studies of GKL-02. Internal Report, 1999
  • 8. Barbareschi M. et al.: Multicenter study on the efficacy of a serum and a shampoo for topical application containing nature-identical thymus peptides for the treatment of androgenetic alopecia and chronic telogen effluvium in women and men. Published in 2013 in the Journal of Plastic Dermatology (Issue 9, 2013 · ISSN 2035-0686)
  • 9. Mössler K.: Thymu-Skin: A New Therapeutic Approach for the Treatment of Androgenetic Alopecia and Alopecia Areata. Der Deutsche Dermatologe 39, Issue 7 (1991)
  • 10. Mössler K., Hagedorn M.: Topical therapy with thymus extract for alopecia areata totalis sive universalis. Reprint from “Der Deutsche Dermatologe” 11/1993, pp. 1175–1182
  • 11. Lüpke N.-P.: Summary report on the adjuvant topical application of Thymu-Skin preparations in patients undergoing cytostatic chemotherapy. Reprint from: Deutsche Zeitschrift für Onkologie 1/90
  • 12. Köhler C. O.: Differences in scalp hair retention during chemotherapy with various therapeutic agents. Internal report from the German Cancer Research Center, Heidelberg, Department of Medical and Biological Informatics.
  • 13. Denck H., Wallner M.: Final report on the second part (Vienna) of the Thymu-Skin hair study. Ludwig Boltzmann Institute for Clinical Oncology at the City of Vienna-Lainz Hospital. May 29, 1989

*not disease-related