Title: Long-term safety study of N-Acetyl-GED-0507-34-LEVO gel 5% applied to the skin for patients with acne vulgaris

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What is this study about?

This study examines the long-term safety and effectiveness of a new topical medication for acne vulgaris, a common skin condition that causes pimples, blackheads, and whiteheads on the face and body. The medication being tested is N-Acetyl-GED-0507-34-Levo gel 5%, which is applied to the skin once daily.

The study aims to determine how safe and effective this gel treatment is when used for up to 52 weeks (one year) in people with acne. The medication will be applied to affected areas on the face, and in some cases, it may also be used on the upper chest, shoulders, and upper back areas where acne is present.

During the study, participants will have regular check-ups where doctors will monitor their skin’s response to the treatment. They will assess changes in acne severity, count the number of acne lesions, and keep track of any side effects. The study will also evaluate how the treatment affects participants’ quality of life. Throughout the study, doctors will monitor participants’ overall health through physical examinations and laboratory tests.

1 Initial visit and assessment

Your skin condition (acne vulgaris) will be evaluated on your face and, if applicable, on your upper body (shoulders, upper back, and chest).

The doctor will perform a physical examination and collect basic health information.

Laboratory tests will be conducted to establish baseline values.

2 Treatment period begins

You will receive N-Acetyl-GED-0507-34-Levo gel 5% for daily application.

The gel needs to be applied once per day to the affected areas.

The treatment will continue for up to 52 weeks (one year).

3 Follow-up visits

Regular check-ups will occur at weeks 12, 26, 38, and 52.

During these visits, the doctor will evaluate:

– Changes in your skin condition

– Any skin reactions at the application site (redness, peeling, dryness, stinging, burning, or itching)

– Your overall health through physical examinations and laboratory tests

You will complete a quality of life questionnaire at the beginning, week 12, and week 52 of the study.

4 Safety monitoring

Throughout the study, any side effects or health changes will be recorded.

The doctor will monitor your vital signs and overall health at each visit.

If you experience any concerning symptoms, they should be reported to the study doctor.

5 Final evaluation

At week 52, a final comprehensive assessment will be conducted.

This includes evaluation of your skin condition, final laboratory tests, and completion of the quality of life questionnaire.

The doctor will perform a final physical examination and review of your overall health status.

Who Can Join the Study?

Must sign an informed consent document before participating in the study
Age requirements:
- Must be at least 9 years old
- Must be under 50 years old
Must have facial acne with specific severity levels:
- For new patients: mild to moderate acne severity (IGA score of 1 or 2)
- For continuing patients: any severity level (IGA score of 0 or higher)
May have body acne (optional) on:
- Shoulders
- Upper back
- Upper chest
Must be able to understand and follow study requirements:
- Patients under 18 must have parent or legal guardian approval
- Must be able to cooperate with study staff
- Must be able to follow study procedures
Women who can become pregnant must use effective birth control:
- Hormonal contraceptives (pills, implants, patches, or injections) for at least 6 months before screening
- Non-hormonal IUD for at least 2 months before screening

Who Cannot Join the Study?

Age below 12 years or above 65 years
Pregnancy or breastfeeding
Known allergic reactions to topical acne medications
Severe or cystic acne requiring oral medication
Current use of other acne treatments (must be discontinued before participation)
Presence of skin conditions other than acne that might interfere with the study evaluations
History of skin cancer or precancerous lesions in the treatment area
Participation in another clinical trial within the past 30 days
Medical conditions that might affect the study results, including:
- Uncontrolled endocrine disorders (hormone-related conditions)
- Severe immunosuppression (weakened immune system)
- Active skin infections
Unable to follow study procedures or attend regular follow-up visits for 52 weeks
History of poor compliance with medical treatments

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Dermed Centrum Medyczne Sp. z o.o.	Lodz	Poland
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
NZOZ Przychodnia Specjalistyczna A-DERM-Serwis	Czestochowa	Poland
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy
Royalderm Agnieszka Nawrocka	Warsaw	Poland

Other Sites

Site Name	City	Country
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
Specderm Poznanska Sp. j.	Bialystok	Poland
Amicare Sp. z o.o. S.K.	Lodz	Poland
Fondazione Luigi Maria Monti	Rome	Italy
Hospital Sant Joan De Deu Barcelona	Esplugues De Llobregat	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Santa Maria Della Misericordia	Perugia	Italy
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.	Szczecin	Poland
Lukmed 2 Sp. z o.o.	Siedlce	Poland
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.	Cracow	Poland
Clinical Best Solutions Sp. z o.o. S.K.	Lublin	Poland
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.	Nowa Sol	Poland
Silmedic Sp. z o.o.	Katowice	Poland
Hospital Universitario Virgen De Las Nieves	Granada	Spain
Vitamed Galaj I Cichomski Sp. j.	Bydgoszcz	Poland
Vita Longa Sp. z o.o.	Katowice	Poland
Klinika Ambroziak Sp. z o.o.	Warsaw	Poland
Universita’ Degli Studi Di Modena E Reggio Emilia	Modena	Italy
Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.	Olsztyn	Poland
Labderm Essence Sp. z o.o.	Ozarowice	Poland
St-Inspire Sp. z o.o.	Mikolow	Poland
Azienda Ospedaliera di Padova	Padua	Italy
Jagiellońskie Centrum Innowacji Sp. z o.o.	Cracow	Poland
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie	Rzeszow	Poland
Etg Neuroscience Sp. z o.o.	Warsaw	Poland
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Universita’ Politecnica Delle Marche	Ancona	Italy
Ko-Med Centra Kliniczne Sp. z o.o.	Zamosc	Poland
Azienda USL Toscana Centro	Prato	Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
Centrum Zdrowia Dziecka I Rodziny Im. Jana Pawla II W Sosnowcu Sp. z o.o.	Sosnowiec	Poland
Universita’ Degli Studi Di Ferrara	Ferrara	Italy
Twoja Przychodnia Poznańskie Centrum Medyczne Sp. z o.o.	Poznan	Poland
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Aicandg Oicrwudiugu Ufznmxuzuebxp Pqqpz	Parma	Italy
Idzziq Irjijxmj Fkiarxeijcpba Ownnvebqbyo	Rome	Italy
Cqytvow Bcmef Kbpulezynst Pgkktnyh Sxh z owpt	Gdansk	Poland
Dtvuajvvgp Mejsqhi Daoqxsyjkvw Cootvy Dh Nq Mswe Esqpb Ggvdjk	Chorzow	Poland
Latsw Csostp Sagc du Ttxtss Kbedpcpajcv dp Auedype Kweftakh	Szczecin	Poland
Pgvelkofuhf Ejpsgrhrbtrw	Wroclaw	Poland
Atecbub Uzkcy Styvyrowi Lhstpa Dx Bhamyxr	Bologna	Italy
Pyzcajv Stn z owtw	Katowice	Poland
Upelfpdnzqopni Cuqunad Ksazkapdv	Gdansk	Poland
Hsegslyp Dk Ln Sjrjg Csih I Shjv Pua	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	30.09.2024
Poland	Not recruiting	30.09.2024
Spain	Not recruiting	30.09.2024

Trial locations

Investigated drugs:

(S)-3-(4-Acetamidophenyl)-2-Methoxypropanoic Acid

N-Acetyl-GED-0507-34-LEVO gel is a topical medication being studied for treating acne vulgaris (common acne). It is applied directly to the skin once daily. This investigational treatment is being evaluated for long-term use to determine if it is safe and effective for people with acne. The gel formulation is designed to be easy to apply and absorb into the skin where acne occurs.

Acne vulgaris – A common skin condition that occurs when hair follicles become clogged with oil and dead skin cells. The condition typically appears as different types of bumps on the skin, including whiteheads, blackheads, pimples, and deeper lumps. It most commonly affects areas of the skin with a high number of oil glands, such as the face, chest, and back. The condition usually begins during puberty when hormonal changes increase the skin’s oil production. Acne lesions develop when the combination of excess oil and dead skin cells creates an environment where bacteria can thrive within the follicles. The resulting inflammation leads to the characteristic redness and swelling associated with acne breakouts.

Trial ID:

2023-510342-24-00

Protocol code:

NACGED0507ACN0123LT

Trial Phase:

Therapeutic confirmatory (Phase III)

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Title: Long-term safety study of N-Acetyl-GED-0507-34-LEVO gel 5% applied to the skin for patients with acne vulgaris

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?