THYMUSKIN^®

1. Reduction in hair loss

Fig. 4: Hair loss assessment in pull test⁸

2. Decrease in seborrhoea and erythema

• Seborrhoea and erythema improvement in 93% and 97% of women respectively
• Seborrhoea and erythema improvement in 89% and 90% of men respectively

Fig. 5: Seborrhoea and erythema symptom improvement

3. Elimination of itching

• Itching eliminated in 74% of women (25/34), with the remaining 26% (9/34) still experiencing light itching
• Itching eliminated in 75% of men (36/48), with the remaining 25% (12/48) still experiencing light itching
• Strong itching completely eliminated for the total of 3 cases of women and 11 cases of men

Fig. 6: Assessment of itching symptoms at beginning of treatment (T0) and end of treatment (T2)⁸

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

Fig. 7: Hair loss assessment in pull test⁸

2. Seborrhoea and erythema improvement⁸

• Seborrhoea and erythema improvement in 93% and 97% of women respectively
• Seborrhoea and erythema improvement in 79% and 76% of men respectively

Fig. 8: Seborrhoea and erythema symptom improvement⁸

3. Elimination of itching⁸

• Itching eliminated in 80% of women (92/115), with 17% (20/115) still experiencing light itching and 3% (3/115) still experiencing moderate itching
• Itching eliminated in 51% of men (21/41), with 39% (16/41) still experiencing light itching and 10% (4/41) still experiencing moderate itching

Fig. 6: Assessment of itching symptoms at beginning of treatment (T0) and end of treatment (T2)⁸

Two studies were performed at the Darmstadt Dermatology Clinic^9,10 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:

• 8 women (average age 42.3, average medical history duration 65.5 months)
• 8 men (average age 30.8, average medical history duration 34.5 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

• The average number of hairs falling out per day decreased from 245 to 10 by the end of the treatment (a reduction of 96%)

Hair loss development

Fig. 11: Quantitative hair loss across a 12-month treatment period⁹

New hair growth⁹

• 86% of patients demonstrated a subjective improvement in results (new hair growth) at the end of the treatment

Fig. 12: Subjective improvement in results by treatment duration⁹

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.

• 5 patients with A. areata totalis (average medical history duration 66 months)
• 15 patients with A. areata universalis (average medical history duration 44.7 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

• Full remission in 40% of patients: complete growth in scalp region (6/20) or full body hair growth (2/20)
• Partial remission in 25% of patients: excellent hair growth (2/20) or moderate growth of head and body hairs (3/20)

Clinical findings in 20 patients with alopecia totalis or universalis

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

• Verum group (n= 56): 41.1% of patients exhibited no alopecia, 17.8% full, reversible alopecia, 26.8% minimal hair loss and 14.3% moderate hair loss
• Placebo group (n=40): 15% of patients exhibited no alopecia, 55% full, reversible alopecia, and 15% minimal or moderate hair loss

THYMUSKIN^® compared to Placebo

Fig. 15: Effect of Thymuskin on hair loss compared to placebo¹¹

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).

• Of those receiving 5-flourouracil treatment, hair condition remained the same in 45% of patients, worsened by one grade in 15% and by two grades in 40%
• Of those receiving Adriamycin treatment, as expected hair condition remained the same in only 5% of patients, worsened by one grade in 35%, by two grades in 40% and by three grades in 20%

Fig. 16: Change of hair loss in oncological patients¹²

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.

• In 68% of patients with breast cancer, 74% of patients with colon cancer, 3% of patients with oesophageal cancer and 36% of patients with other cancers, hair condition remained unchanged during the treatment with 5-FU.
• Among patients with stomach cancer and undergoing Adriamycin treatment, hair condition remained unchanged in only 2% (2/96). However, alopecia totalis was prevented in 70% of patients.

Change of hair loss in various forms of cancer

Fig. 17 (left): Change of hair loss in various forms of cancer undergoing treatment with 5-fluorouracil¹²
Fig. 18 (right): Change of hair loss in various forms of cancer undergoing treatment with adriamycin¹²