1. August 2022 Press0

New scientific paper published on the mechanism of action of Polyphenon® E, a defined extract from green tea leaves, in preliminary stages of skin cancer

Strausberg, 28 July 2022


DERMAGO GmbH today announced the publication of an article by the research group of PD Dr. J. Eberle from Charité-Universitätsmedizin Berlin, Germany.

The article entitled “Inhibition of Cell Proliferation and Cell Viability by Sinecatechins in Cutaneous SCC Cells Is Related to an Imbalance of ROS and Loss of Mitochondrial Membrane Potential” was released in the peer-reviewed journal Antioxidants1

The complete publication can be found on the internet at the following link

Within the framework of the study, the authors led by PD Dr. Eberle and Prof. Dr. Stockfleth were able to demonstrate that Polyphenon® E induces a concentration-dependent inhibition of cell proliferation as well as a reduction of cell vitality in four different squamous cell carcinoma cell lines (SCL-I, SCL-II, SCC-12 and SCC-13). These modifications correlate with changes in mitochondria as well as with an imbalance of cellular reactive oxygen compounds. The new findings support the previously known comprehensive mechanism of action2 of Polyphenon® E. On the basis of the results, the authors conclude a possible efficacy of Polyphenon® E in the indication actinic keratosis (AK).


Preliminary squamous cell carcinomas such as actinic keratosis (AK) have been among the most common skin diseases treated by dermatologists. Furthermore, a significant increase in actinic keratoses has been observed in the last decade. Apart from etiological factors such as chronic UV exposure, this can be attributed to demographic change with a higher proportion of older people in the population. An estimated 1.7 million people in Germany are currently undergoing dermatological treatment for AK. Actually, the number of patients suffering from AK is much higher and is expected to increase in the next years in line with the population structure. 3


The exclusive manufacturing patents for the active ingredient “Polyphenon® E” (synonyms: “defined extract from green tea leaves” and “sinecatechins”) were taken over by Dermago GmbH from Mitsui Norin Co., Ltd., Japan, in December 2021.


1Zhu, J.; Gillissen, B.; Dang Tran, D.L.; May, S.; Ulrich, C.; Stockfleth, E.; Eberle, J. Inhibition of Cell Proliferation and Cell Viability by Sinecatechins in Cutaneous SCC Cells Is Related to an Imbalance of ROS and Loss of Mitochondrial Membrane Potential. Antioxidants 2022, 11, 1416.


2Apoptotic Gene Expression in Sinecatechins-Treated External Genital and Perianal Warts, Stephen K. Tyring et al, Viral Immunology, Volume 27, Number 10, 2014

Sinecatechins, Effects on HPV-Induced Enzymes Involved in Inflammatory Mediator Generation, Stephen K. Tyring, The Journal of Clinical_Aesthetic Dermatology, January 2012, Volume 5, Number 1

Effect of Sinecatechins on HPV-Activated Cell Growth and Induction of Apoptosis, Stepehn K. Tyring, The Journal of Clinical_Aesthetic Dermatology, February 2012, Volume 5, Number 2


3 S3 guideline actinic keratosis and cutaneous squamous cell carcinoma long version 1.1 – March 2020, AWMF registration number: 032/022OL


Contact data:


DERMAGO Verwaltungs GmbH

Kastanienallee 46

15344 Strausberg, Germany


Phone: 03341-589 90 40

21. July 2022 Press0

Aresus announces presentation of clincial data for the treatment of female sexual pain with sinecatechins ointment

Strausberg, Germany, 21 July 2022

 Aresus Pharma GmbH, a subsidiary of DERMAGO GmbH, announced today that clinical results on the efficacy of 5-10% Topical Sinecatechins (synonyms: “Polyphenon® E“, ”defined extract from green tea leaves“) Ointment for Postmenopausal Vestibulodynia1 were presented  at the 2nd Congress on Women’s Health Innovations & Inventions in Tel Aviv on July 11-12th, 2022. Additionally, the poster had previously been presented at the North American Menopause Annual Meeting in Washington, D.C. in December 2021 and at the International Society for the Study of Women’s Sexual Health Annual Meeting in Dallas, Texas in March 2022.

The research was performed by a clinical team under the lead of Dr. Lila Nachtigall, Professor of Obstetrics and Gynecology at New York University School of Medicine.

In the randomized, double-blind, placebo-controlled trial, 32 postmenopausal sexually active women with significant to severe secondary provoked vestibulodynia were enrolled. The authors concluded that topical 5% sinecatechins ointment applied once daily or 10% sinecatechins ointment applied three times a week significantly reduced provoked secondary vestibulodynia in postmenopausal women without having a proliferating effect on the vaginal epithelium.

The funds for the study were provided by GTO Pharmaceutical, LLC (GTO). GTO Pharmaceutical, LLC and Aresus Pharma GmbH are evaluating the further development and commercialization strategy for the use of sinecatechins ointment in vestibulodynia.

Dr. Wendy (Keller) Epstein, CEO of GTO Pharmaceutical, LLC.  and, Adjunct Assistant Professor of Dermatology at New York University School of Medicine comments:

“A large proportion of  postmenopausal women need access to an effective non-hormonal topical drug that alleviates vestibulodynia, the most common cause of sexual pain. Sinecatechins ointment fulfils this unmet medical need because it can be used by women with or without a history of estrogen sensitive malignancies.

Although requiring further study, researchers reported that several women noted an increase in lubrication, sexual arousal and/or decreased latency to orgasm, a finding consistent with the known neurobiology of female sexual pain and arousal “.

Vestibulodynia is chronic pain and discomfort that occurs in the area around the opening of the vagina, inside the inner lips of the vulva. This area is known as the vestibule. The pain may occur when the area is touched, when a tampon is used, during sexual intercourse, during a pelvic exam, when tight clothes are worn, or even when sitting for a long time. In some cases the area may also be red and inflamed. Vestibulodynia is a specific type or localized form of vulvodynia, chronic pain of the vulva.2 It is estimated that at least 16% of women in the United States are affected by vestibulodynia.3

1 Nachtigall L, et al Efficacy of 5-10% Topical Sinecatechins Ointment for Postmenopausal Vestibulodynia.  Menopause Vol 28  No. 12 2021 pp 1467

2 Vestibulodynia – What Is Vestibulodynia? Baylor Medicine (last access: 20.07.2022)

3 The causes and prevalence of vestibulodynia: a vulvar pain disorder,   Feldhaus-Dahir, M. Urol Nur . Jan-Feb 2011;31(1):51-4.

Related Literature:

Shahrahmani H, Kariman N, Jannesari S, et al. The effect of green tea ointment on episiotomy pain and wound healing in primiparous women: A randomized,double‐blind, placebo‐controlled clinical trial. Phytotherapy
Research. 2018;32:522–530.

Press contact:


Kastanienallee 46

15344 Strausberg


phone: ++49 (0) 3341-589 90 40

14. July 2022 Press0

Dermago takes over laboratory furniture of Life Science Inkubator GmbH in Bonn to build up their own analytical laboratory

Strausberg, 12 July 2022

The pharmaceutical company DERMAGO GmbH, based in Strausberg, Brandenburg, acquired around 300 m2 of laboratory furniture  from Life Science Inkubator GmbH, Bonn, in June 2022. The equipment became available due to the discontinuation of LSI’s incubation activities and is to be reassembled in DERMAGO GmbH’s new laboratory facilities at the Strausberg site. The company expects the construction work to be completed by the 4th quarter of 2022.

With this investment in the Strausberg site, DERMAGO intends to carry out the pharma analytics in-house for its subsidiaries Aresus Pharma, Skin Care Pharma and Degode Pharma in the future and expects significant cost savings as a result. In addition, Dermago will also offer the analytical services to external companies.

The establishment of the infrastructure as well as further product development will be co-financed through the company’s capital round concluded via Companisto in June 2022.


DERMAGO GmbH is a service company that has been specializing in the development of unique generic versions and originator preparations of prescription, reimbursable dermatological pharmaceuticals and in independently advancing these through the pharmaceutical approval process. The services of DERMAGO GmbH also include consulting activities, scientific assessments, the preparation of expert reports as well as qualitative and quantitative studies especially for dermatological pharmaceuticals. The development of analytical methods and procedures as well as services for obtaining marketing authorization for pharmaceutical products are also part of the range of the company’s activities.

About LSI Life Science Inkubator

In a trial phase lasting more than 10 years, the Bonn-based Life Science Inkubator GmbH (LSI) built up a unique incubation concept for people interested in founding a company. Innovative projects in the fields of biotechnology, pharmaceuticals and medical technology were evaluated at an early stage and developed together with the project group until they were ready for financing and market launch. After completion of the instrument testing in June 2022, the Life Science Inkubator discontinued its incubation activities. The spin-offs that have emerged from the incubation in recent years will continue to be managed by the incubator’s investment company, LSI Pre-Seed-Fonds GmbH.


Press contact:


Kastanienallee 46

15344 Strausberg

Phone: 03341-589 90 40

24. September 2021 Press0

Skin Care Pharma GmbH, a company of Dermago Verwaltungs GmbH, announces that yet another milestone has been reached in the development and approval of Skinatan® 1 mg/g Emulsion for cutaneous application with the active ingredient methylprednisolone aceponate (MPA). Upon receipt of the “End of Procedure” notification, the decentralized procedure (DCP) for Skinatan® 1 mg/g Emulsion has been successfully completed for six European member states. Within the next few weeks, Skin Care Pharma GmbH and its license partners are to be granted marketing approval for Skinatan® 1 mg/g Emulsion by the respective national authorities.

 Skinatan® 1 mg/g Emulsion is a dermatological milk for cutaneous use with the active ingredient methylprednisolone aceponate (MPA). MPA belongs to the latest generation of topical glucocorticoids, characterized by a favourable therapeutic index i.e. a positive ratio of effect and side effect.

Skinatan® is a generic version of Advantan®. Advantan® is approved and available in more than 60 countries world-wide with an annual turnover in excess of $100m.

Advantan® Milk 0.1% Emulsion for cutaneous use is approved among others for acute treatment of mild to moderate skin rashes (eczemas), such as allergic reactions, nummular eczema, dyshidrotic eczema, nonspecific skin rash, and atopic dermatitis or neurodermatitis or scaly and reddened skin rash (seborrheic eczema).

Skin Care Pharma GmbH

Skin Care Pharma GmbH was founded by Sven Schimansky-Wabra in 2012. Skin Care Pharma GmbH specializes in the development of semi-solid pharmaceuticals as generic versions. In 2016, the German regulatory authority BfArM officially confirmed the formulation of the generic Skinatan® pharmaceuticals in four different topical dosage forms (solution, emulsion, cream and ointment).

As early as 2020, Skinatan® 1 mg/ml Solution for cutaneous application was successfully developed and approved. In Germany, the latter is marketed by the partner GALENpharma GmbH under MetiGalen®. This is followed suit by the approval of Skinatan® 1 mg/g Emulsion for cutaneous application. For the further development of Skinatan® Cream and Ointment, Skin Care Pharma GmbH was able to successfully complete two pivotal clinical studies and has already applied for marketing approval of both formulations in seven European countries by means of a decentralized procedure (DCP).