Study on the Effectiveness and Safety of HRO350 for Patients with Mild-to-Moderate Psoriasis

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment for psoriasis, a skin condition that causes red, itchy, and scaly patches. The treatment being tested is called HRO350, which contains a substance known as PEHeRo (phospholipid esters from herring roe oil). The study will compare the effects of two different doses of HRO350 to a placebo in people with mild-to-moderate psoriasis. The goal is to find the most effective dose for future studies.

Participants in the study will take the treatment in the form of soft capsules by mouth. The study will last for several weeks, during which participants will be monitored to see how their psoriasis responds to the treatment. The study will also look at the safety of the treatment and any side effects that may occur. Throughout the study, participants will have regular check-ups to assess their skin condition and overall health.

In addition to HRO350, the study will also involve the use of betamethasone valerate, a common ointment used to treat skin inflammation, as part of the treatment process. The study aims to provide valuable information on the effectiveness and safety of HRO350, helping to determine the best dose for future research and potential use in treating psoriasis. Participants will be closely monitored to ensure their safety and well-being throughout the study.

Who Can Join the Study?

You must provide a signed and dated informed consent, which is a document where you agree to participate in the study after being told about all its details.
You must be male or female and at least 18 years of age.
You must have been diagnosed with chronic, active plaque psoriasis, which is a long-term skin condition that causes raised, red, and scaly patches, and this condition must be mild to moderate in severity.
Your psoriasis must have continued for at least 6 months without using systemic treatment, which refers to medications that work throughout your entire body rather than just on the skin surface.
Your Psoriasis Area and Severity Index (PASI) score, which is a tool used to measure how much skin is covered and how severe the symptoms are, must be between 3 and 10.
Your Body Surface Area (BSA), which is the measurement of how much of your total body skin is affected by the condition, must be at least 3.
Your Static Physician’s Global Assessment (sPGA) score, which is a scale used by a doctor to rate the overall severity of your skin condition, must be between 2 and 4.
Men and women who are able to have children must agree to use highly effective birth control, such as implants, certain pills, or devices placed in the uterus, throughout the study and for 30 days after finishing the treatment.
Women will be considered to have the potential to have children unless they have had surgery to prevent pregnancy, such as a hysterectomy (removal of the uterus) or tubal ligation (closing the fallopian tubes), or if they have not had a period for at least 12 months due to menopause.

Who Cannot Join the Study?

You cannot participate if you have used phototherapy, which is a treatment that uses ultraviolet radiation (light rays from the sun or special lamps) to treat skin conditions, within 8 weeks before the study starts or during the study.
You cannot participate if you have taken any investigational drug, which is a medicine that is currently being tested in a clinical trial, within 4 weeks before the study starts or during the study.
You cannot participate if you have used systemic anti-psoriatic treatment, which are medicines that work throughout your entire body to treat psoriasis, within the last 3 months before the study starts or during the study. For biologics, which are specific types of medicines made from living organisms to target certain parts of the immune system, this period is 6 months.
You cannot participate if you have used topical anti-psoriatic treatment, which are creams, ointments, or gels applied directly to the skin, within the last 2 weeks before the study starts.
You cannot participate if you have changed any anti-inflammatory medication, which are drugs used to reduce swelling and pain for other long-term illnesses, within the last 4 weeks before the study starts or during the study.
You cannot participate if you have taken omega-3 fatty acid supplements or medicines, which are nutrients often found in fish oil, within the last 2 weeks before the study starts or during the study.
You cannot participate if you have a known allergy, which is an immune system reaction, to fish or vegetable oils such as soy.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Technische Universitaet Dresden	Dresden	Germany
Hautzentrum Weißensee, Studienzentrum KorSearch	Berlin	Germany
Medicover Integrated Clinical Services Sp. z o.o.	Bydgoszcz	Poland
Evimed Sp. z o.o.	Warsaw	Poland
Dermoklinika – Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak	Lodz	Poland

Other Sites

Site Name	City	Country
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Ko-Med Centra Kliniczne Sp. z o.o.	Pulawy	Poland
Mwalplkgg Infwizykcg Ceugznwi Sxhdrvzj Swx z omti	Warsaw	Poland
Ubouarfsonjworlglwjeh Nazaupmzml Hn	Tromsø	Norway
Uncyviwuatqerpcbnblab Ehqlkzpw Ayt	Erlangen	Germany
Hontw Bctmed Ht	Bergen	Norway
Undxbsvxuwlmexnvfyjqa Mflyigro Are	Munster	Germany
Ulvqcbzvffhtxfucbbenc Hneeoapbiy Atf	Heidelberg	Germany
Uyqzmiufgbxmkxggypflt Ebhxs Ajx	Essen	Germany
Uwnhxnmngkgjpvehtwzvv Stzveefxxlgkxgqmig Adf	Kiel	Germany
Hxrld Sxjwnltlq Hp	Stavanger	Norway
Krdexnq Atjdkrhax Stx z oxjg	Warsaw	Poland
Dvbbdguegbdo Qucgh	Mainz	Germany
Ävcmzisrl Rwondq Vklwucy	Berlin	Germany
Houoe uuo Lgrxfstcjpgj Hpwmenouh Dagiokmkjlgjtuzc Skliupflhewlab	Simmern	Germany
Ahlec Hcu As	Arendal	Norway
Uljuayxvpz Hsgjgfrp Ol Nuvmi Noygeh Hp	Harstad	Norway
Rtjei Cbjhoc Scv z oejv	Bialystok	Poland
Hkyckbdjbdtqej Dj Mpu Mrvrftjg Hlxmmcjb	Witten	Germany
Pokekx fnn Hutirmtydok uys Obdoedagr Bmtsik Mmkxo	Berlin	Germany
Slasjxmmbhlnix au dbz Hmai Grr	Bramsche	Germany
Imttjlgv Zmnsxef Dg Bqeayolkfywshajmz	Oświęcim	Poland
Humfbfcfakq Bep Szcco Sqiolvdtxrhcyf Ggto	Bad Soden	Germany
Pbwbwugb	Duelmen	Germany
Lzhgkh Mrnvkdqkcc Udcxokmrsh Ot Mlnlar	Munich	Germany
Nhargabo Iiqrdicq Gkwkuwclg Rpnewlupexlc I Raolxyyvixgky Ix Pqfhe Dx Hxyp Mpmv Eoszsdwa Rvfmtut	Warsaw	Poland
Ggygxa Uatudqdzrf Fbnszngmi	Frankfurt	Germany
Hdaye Mcrss Ov Rxmvfoj Hg	Aalesund	Norway
Hxocipbjdvxd Dnauowsn Cmbruewoph Enjnaklh Guoo	Quedlinburg	Germany
Cfkvoxda Reeozois Swrzrcqw Toejd Chuz Ow	Turku	Finland
Hvlkwkjxcuhadu Doq Llpil Uvo Kwzgwlle	Stuttgart	Germany
Tqxztljtzvj uuc Sreqgakwfro Bttukqsl Gnxe	Bad Bentheim	Germany
Cyjv Hhqgsvrk Ol	Helsinki	Finland
Mnftgnctzbprgwgljiky Ggay	Hamburg	Germany
Rvndnnwir Reqqgtxc Ggfp	Darmstadt	Germany
Nkvqmvwxxvwblkxiba Hz	Bodo	Norway
Cdmhvsf Mwwcfmrc Agpfhjm Bdnmmow Kbxrvzrdu	Cracow	Poland
Kskbivyc Bccdojjdq gixht	Bielefeld	Germany
Dmfubyhxmnofvahfem Fpzlrpkuykeqatq Gilp	Friedrichshafen	Germany
Isw Ikwalnxdujblfwhjv Sazxw Aucagnjuajk Ggws	Berlin	Germany
Oopwkqf Smu z onxz	Warsaw	Poland
Mzjhnacobg Gsys	Friedrichsdorf	Germany
Kgjfzrj Ozduwatoz &atzt Tngfyqmut Stg z orez	Warsaw	Poland

Trial status

Country	Status	Recruitment Start
Finland	Not recruiting	01.03.2023
Germany	Not recruiting	01.03.2023
Norway	Not recruiting	01.03.2023
Poland	Not recruiting	01.03.2023

Trial locations

Investigated Drugs:

Pehero is an oral medication being tested to see how well it works and how safe it is for people living with mild-to-moderate psoriasis.

Betamethasone valerate is a topical cream used as background therapy to help manage skin symptoms.

Investigated Diseases:

Psoriasis

Psoriasis – This is a chronic condition that affects the skin by causing cells to multiply much faster than normal. These excess skin cells build up on the surface, forming thick, red, and scaly patches. The affected areas can appear on various parts of the body, such as the elbows, knees, or scalp. As the condition progresses, these patches may become itchy, sore, or cracked. The appearance and severity of these skin changes can fluctuate over time.

Trial ID:

2022-501850-12-00

Protocol code:

HRO350-PS-2B HeROPA

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effectiveness and Safety of HRO350 for Patients with Mild-to-Moderate Psoriasis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?