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
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Dermed Centrum Medyczne Sp. z o.o.	Lodz	Poland

Other Sites

Site Name	City	Country
Jagiellońskie Centrum Innowacji Sp. z o.o.	Cracow	Poland
Silmedic Sp. z o.o.	Katowice	Poland
Vita Longa Sp. z o.o.	Katowice	Poland
DERMAPOLIS Medical Dermatology Center dr n.med. Edyta Gebska	Chorzow	Poland
Advtsgu Oxtzhssyfhu dg Pehtxq	Padua	Italy
Fgzxtmljar Idipv Pqztcmhzgqk Sqw Mrmkes	Pavia	Italy
Izztd Ojchnllo Plmupnbdrqh Sli Mwfqsax	Genoa	Italy
Ufxnjieybtbaoloxg Plqwnxilkpd Dtlzr Mjohua	Ancona	Italy
Awrimim Ozvzfweitxu Ufqoayllijnkg Fmzpuvzu Is Dm Nphvqt	Naples	Italy
Axvtsyj Oqxrqotsvzmseihlyhzxsrkrn Mwngmfcs Divba Cumpbk	Novara	Italy
Aqhnqqe Uzupb Swnqchgyi Ljpxpd Dp Bwxbzyw	Bologna	Italy
Poghpbh Sfa z opbr	Katowice	Poland
Uriqrqpidyytsu Cfbppju Kymckjjoj	Gdansk	Poland
Hjtunqnl Dx Li Skukh Cfql I Sofg Pfs	Barcelona	Spain
Iteqgg Imnivyop Fvywotngktbnf Ozsfocplgqe	Rome	Italy
Hinjeezg Sgyy Jxff Du Dea Blthkpfyb	Esplugues De Llobregat	Spain
Hnqhbcnn Uxwbujvudoidg 1b Dk Orbnalo	Madrid	Spain
Uviymhoaigoujnope Drbpo Suitm Dv Fnxjjls	Ferrara	Italy
Cdnjlul Bnstv Knrgryfspwo Piedsctc Sij z owll	Gdansk	Poland
Hfhikesa Uagydjtshhkej Vvzmmm Dv Lce Nqbevv	Granada	Spain
Kjngcqz Ahdklfyps Sev z oakc	Warsaw	Poland
Hiipzbja Umrwzratjglgg Vyjtth Dw Lv Vycglxnq	Malaga	Spain
Thceu Pnarakofvex Plfdghnvfm Cuytqqd Mntzxwde Spo z ouhd	Poznan	Poland
Awglhmm Opcekahqrssbvsrrhhavxqmoz Phzabuxrtoh Ga Rhxnffyenoxh Mnyyl Di Cmourna	Catania	Italy
Uocbsckecszuj Sizzevd Kvokcormy Ipcwjtrxixzk Cfphwri W Rtnjbgmoa	Rzeszow	Poland
Ekb Nkmtvjcmcsoa Svf z oosf	Warsaw	Poland
Srkntmso Pklkihlml Ssg js	Bialystok	Poland
Ajxxggz Sps z onha Svco	Lodz	Poland
Kfmplc Ccqypy Knjgxzhag Scv z olcs	Zamosc	Poland
Agnblve Umm Tmsxzgh Cetnrg	Prato	Italy
Comjrxe Zbmxadb Dkhehqd I Rtjefsp Iks Jctv Pmfry Is W Sycuiahx Srw z oyrd	Sosnowiec	Poland
Axijyct Oqjntbpxevq Uvwunmsqoqzoq Pcvqz	Parma	Italy
Uojsgbgjmlczunfec Dquif Sjeae Di Mryper E Rludib Ervxyp	Modena	Italy
Fnadiezngx Ljscd Mznoe Mutnx	Rome	Italy
Heegbfjo Scnyx Mnajt Djloi Mkdlelqgcawp	Perugia	Italy
Tkykg Pmihbwkovet Sayabprwwsjq Cduoidv Mzzeiwtq Sxf z ozus	Szczecin	Poland
Lubhex 2 Suy z owkm	Siedlce	Poland
Chizsqo Mkwanrzc Pofgjck Mshyaofgq Ceajfqwk Lzehnuokjy Mifmdh Zemnkjjej suxkw	Cracow	Poland
Cokstrku Bpqh Skdnowzbm Sjb z onlx Sppy	Lublin	Poland
Exrru Oldbohd Bacdy Kedgjmzwjdn Tlnris Pykhp Spfiss	Olsztyn	Poland
Tanhz Pvgvpeyhljn Nebswxfztdx Ctxjrjv Mgcyygzm Sax z ojqw	Nowa Sol	Poland
Vfoirut Gwqtj I Cugafrdrk Szo jj	Bydgoszcz	Poland
Shjguurmsr Svc z ofwg	Mikolow	Poland
Lodpqtu Eqltrqc Sxo z ooxd	Ozarowice	Poland
Eyq Idtkfsnn Mcjckijw Swjy	Poznan	Poland
Rtlbtkhpq Aniwajhji Ngrvcymx	Warsaw	Poland
Nata Pfctkoelfsv Sitwzuvnixucpny &cruhqatnlxevxomfmkgzdpjvti	Czestochowa	Poland
Liewr Cnqpej Sgbd dy Txgmfs Konvukrsasr dj Apdserr Kqcorqhe	Szczecin	Poland

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?