An overview of key study findings
Studies and controlled observational scientific investigations performed on more than 1,000 men and women at dermatology and university clinics in Germany and internationally have verified the effectiveness of Thymuskin on all forms of hair loss. The success rate for androgenetic hair loss, telogen effluvium, alopecia areata and mild forms of cytostatic drug-induced alopecia averages well over 90%, with no side effects involved even with long-term use. The most important study findings have been compiled into this pamphlet.
Thymuskin is a dermatological system to counter hair loss and to activate new hair growth for both men and women. It is highly effective, offers very good tolerability for various types of hair loss and does not have any side effects.
The dermatological Thymuskin system consists of the combined application of Thymuskin Shampoo and Thymuskin Scalp Serum. Thymuskin contains the patented GKL-02 active complex which mimics natural thymus extract and is free of animal-derived ingredients.
The GKL-02 thymic peptide active complex improves supply to hair follicle cells during the growth phase, boosting the formation of new hair cells and strengthens those already in place. It also extends the hair's growth phase. Hair follicles remaining intact are reactivated, new hairs are formed and the growth phase is significantly extended. In addition, Thymuskin boosts immune defenses and reduces the number of follicle cells dying off.
Thymuskin has been effective against hair loss for more than 30 years – a track record which is unique worldwide. This lasting success is based on the intensive research and study work undertaken by the Klett-Loch company group.
OVERVIEW OF THYMUSKIN® CLINICAL STUDIES
THE THYMUSKIN® ACTIVE COMPLEX
In addition to natural substances and cosmetic ingredients, Thymuskin also contains the patented active thymic peptide complex GKL-02.
Unique worldwide, this active complex is the result of many years of research. In this peptide library thirty three amino acid derivatives are chemically combined in a statistic manner with each other and lastly physically combined with seventeen naturally occurring amino acids, either as such, as their salts and as their derivatives. This results in a unique active substance that contains di-, tri-, tetrapeptides as well as free amino acids. The peptides in the GKL-02 active thymic peptide complex were created using a peptide synthesis process (rather than being extracted from animal tissue) and therefore contain no animal components. The composition of this statistical peptide library mimics that of calf thymus gland total extract.
The average molecular weight of the individual peptides is between 180 and 600 daltons, thus facilitating penetration through the follicle skin layer after being applied to the scalp. As the GKL-02 active thymic peptide complex contains numerous components which act synergistically, the mode of action cannot be attributed to a single peptide; instead, the active complex as a whole is responsible for the various biological effects on hair growth. These effects have been successfully proven in numerous preclinical and clinical studies.
THYMUSKIN® mode of action
Thymuskin has an immunological effect on hair follicles, as is typical for a thymic preparation. The innovative peptide synthesis technology enables the peptides to penetrate deeply into the skin and to reach the hair follicle without any difficulty.
Thymuskin stops hair loss and stimulates new hair growth by increasing keratinocyte cell viability, boosting lymphocyte proliferation, inhibiting the effect of mast cells on hair follicles, and directly modulating hair follicle growth.
1. Increased lymphocyte proliferation
Studies performed on human blood cells have shown that Thymuskin stimulates lymphocytes to divide. This effect was dependent on the concentration administered, and was statistically significant compared with the untreated group (p=0.03). The mechanism behind this stimulation is unrelated to interleukins.1 The increased proliferation of lymphocytes is most likely connected to immunological regulation and modulation of hair growth. Autoimmune processes play a particular role in alopecia areata.
Increased keratinocyte cell viability
Thymuskin was investigated using the EpiDerm® model. The test tissue in this model consists of a multi-layer culture of human keratinocytes (keratin-forming cells in the epidermis) and is very similar to human skin in both structure and function. In the study, a 10% Thymuskin solution resulted in increased viability of the test tissue – measured by the activity of mitochondrial dehydrogenases. Viability increases as Thymuskin concentration and duration of exposure are increased (see fig. 2).2 Thymuskin appears to have a comparable stimulating effect on hair-forming keratino- cytes in hair follicles. This biological effect also explains why Thymuskin is effective on various forms of hair loss.
Tissue Viability of GKL-02
Inhibition of effect of mast cells on hair follicles
Using a mouse model, an increase in mast cells and their degranulation in the skin was observed during the catagen transition phase. Mast cells were no longer observed following hair loss.
Mast cells are able to modulate the proliferative activity of hair follicles, and thus also to affect hair growth in various ways. This appears to play a particular role in stress-related hair loss.
As is well known, mast cells contain the serine proteases trypsin (chymotrypsin) and tryptase which activate keratinocytes' protease-activated receptors (PARs). It was shown that Thymuskin inhibits both tryptase and trypsin (see fig. 3). Given the role of mast cells outlined above and the inhibition of serine proteases from mast cells, it can be postulated that Thymuskin may reduce or even prevent follicle cell death.
Direct modulation of human hair follicle growth
A current study has successfully shown that selected thymic peptides (such as thymosin beta-4, prothymosin alpha and thymulin) are produced by human hair follicle epithelium and act as direct modulators for human hair follicle growth.6 This independent study underlines all elements of the Thymuskin effect hypothesis.
Good skin penetration
The biological effects named above are only relevant if a sufficient concentration of Thymuskin also reaches the hair roots. In vitro penetration studies on human scalp and abdominal skin have shown that around 45% of a 0.1% Thymuskin solution penetrates sufficiently deep into the skin. The majority of the Thymuskin active ingredient reaches hair follicles via the hair shaft. It has therefore been shown that when locally applied, Thymuskin penetrates into the depths of the skin where it takes effect.
A multicentric study8 was undertaken investigating the effectiveness and tolerability of Thymuskin (serum and shampoo) in the initial phase of androgenetic alopecia (AGA) and chronic telogen effluvium (chronic TE) over a period of six months. The study included 364 test subjects split as follows:
The patients used the serum once a day and the shampoo three times a week over a total period of 24 weeks. All test subjects underwent a pull test and a symptom evaluation (seborrhoea, erythema and itching) performed by the investigator. Tolerability and cosmetic acceptance/tolerance were also assessed. After six months of treatment, patients with AGA and patients with chronic TE both demonstrated a significant decrease in hair loss, a stimulation of hair growth and a reduction in the symptoms of seborrhoea, erythema and itching. Tolerability and cosmetic acceptance were good to very good in the majority of patients.
1. Reduction in hair loss
Decrease in seborrhoea and erythema
3. Elimination of itching
THYMUSKIN® effectiveness in patients with androgenetic alopecia
CHRONIC TELOGEN EFFLUVIUM
A multicentric study8 (see page 7) was undertaken investigating the effectiveness and tolerability of Thymuskin (serum and shampoo) in 184 women and 57 men with chronic telogen effluvium (chronic TE) over a period of six months.
1. Reduction in hair loss8
99% of women (182/184) and 98% of men (56/57) demonstrated an improvement in the pull test
2. Seborrhoea and erythema improvement8
3. Elimination of itching8
THYMUSKIN® effectiveness in patients with androgenetic alopecia8
Two studies were performed at the Darmstadt Dermatology Clinic9,10 on a total of 36 patients. The first study at the Darmstadt Dermatology Clinic9 investigated Thymuskin's effectiveness in 16 patients with alopecia areata (AA) over a period of 12 months:
The patients exhibited either more than five hairless areas or were suffering from ophiasis-typealopecia. Half of the patients had previously undergone one or more preliminary treatments, which offered fleeting success in only two patients.
The patients used Thymuskin shampoo and scalp serum for a period of 12 months: hair shampoo daily for the first two weeks then three times a week, serum twice daily in the first two weeks then once a day in the morning. The success of the treatment was evaluated using subjective assessments by the doctor and patient as well as objective parameters (quantity of hairs falling out per day). The patients experienced a reduction in daily hair loss during the treatment, and the majority of patients experienced renewed hair growth.
1. Reduction in hair loss
Hair loss development
New hair growth9
In another study by the Darmstadt Dermatology Clinic10, 20 patients (14 women and 6 men, including 2 children) with A. areata totalis or A. areata universalis used Thymuskin for a period of 9-24 months.
Most patients had previously undergone unsuccessful treatment with steroids, diphenylcyclopropenone (DPCP), 4-[(4-aminobenzene)sulfonyl]aniline (dapsone) or PUVA. The patients in the study used Thymuskin Shampoo daily for the first two weeks and then two or three times a week. The scalp serum was used twice daily in the first two weeks and then once a day. After 9-24 months, 65% of patients exhibited new hair growth and 40% of patients were in full remission. In comparison, treatment with DPCP usually results in full remission being observed in approx. 21-28% of patients.10
3. Full and partial remission
Clinical findings in 20 patients with alopecia totalis or universalis
THYMUSKIN® effectiveness in patients with alopecia areata
CYTOSTATIC DRUG-INDUCED ALOPECIA
A multicentric study11 was undertaken to investigate the extent to which hair loss as a side effect of cytostatic chemotherapy can be affected by the prophylactic application of Thymuskin alongside the treatment. It also investigated the extent to which different cytostatic drugs and underlying diseases affect hair loss. A total of 317 patients with different cytostatic drug regimens took part in the study.
Hair loss was evaluated before and during the treatment using the WHO classification. In one of the study locations, patients were split into a verum arm and a placebo arm as part of a randomized double blind study. Instead of Thymuskin, the patients in the placebo group received a preparation with no active ingredients. In order to investigate the effect of cytostatic therapy and underlying diseases on hair loss, the study results from the individual centers were compiled together.12
1. THYMUSKIN® effectiveness compared to placebo12
THYMUSKIN® compared to Placebo
2. Effect on chemotherapy regimen on hair loss
144 patients received 5-fluorouracil (monotherapy or combination therapy), 107 patients received the more 'aggressive' Adriamycin (monotherapy or combination therapy).
3. Effect of tumour on hair loss
a0% (96/107) of the patients being treated with Adriamycin were suffering from stomach cancer. In the group being treated with 5-fluorouracil, the less aggressive cytostatic drug regimen resulted in a different distribution: 31% (44/144) were suffering from breast cancer, 23% (33/144) from oesophageal cancer, 16% (23/144) from colon cancer, 11% (16/144) from pancreatic cancer and 19% (28/144) from another malignant disease.
Change of hair loss in various forms of cancer
THYMUSKIN® effectiveness alongside treatment in cases of cytostatic drug-induced alopecia (chemotherapy)
The dermatological THYMUSKIN® 2-step system against thinning hair and for the activation of new hair follicles
System: shampoo & treatment serum for combined daily usage in 100ml & 200ml sizes
2 steps to the right choice of THYMUSKIN® Shampoo & Scalp Treatment Serum therapy-combination