Study of N-Acetyl-GED-0507-34-LEVO gel 5% applied daily for treating acne vulgaris

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What is this study about?

This clinical trial studies the effectiveness and safety of a new topical medication for treating acne vulgaris, a common skin condition that causes pimples, blackheads, and whiteheads on the face and body. The study tests N-Acetyl-GED-0507-34-Levo gel 5%, which is applied to the skin once daily, comparing it to a placebo gel over a period of 12 weeks.

The study focuses on treating acne on both the face and trunk (upper chest, shoulders, and upper back) areas. The medication is being tested to see how well it reduces different types of acne lesions, including inflammatory lesions (red, swollen bumps) and non-inflammatory lesions (blackheads and whiteheads). The study will measure changes in the number of acne lesions and overall improvement in skin appearance.

Throughout the study, participants will have their acne assessed using standardized scoring systems. The research team will monitor the skin’s response to treatment and any potential side effects. The study also includes evaluations of how acne affects quality of life using special questionnaires. Safety monitoring includes checking for skin reactions at the application site, such as redness, peeling, dryness, stinging, burning, or itching.

1 Initial evaluation

Your participation begins with an assessment of your facial acne vulgaris condition

The doctor will evaluate the number of inflammatory lesions (papules and pustules) and non-inflammatory lesions (comedones) on your face

If applicable, trunk acne (shoulders, upper back, and upper chest) will also be evaluated

2 Treatment assignment

You will receive either N-Acetyl-GED-0507-34-Levo gel 5% or a vehicle gel (gel without active ingredient)

The gel needs to be applied once daily to affected areas

The treatment period lasts for 12 weeks

3 Regular assessments

Your acne condition will be monitored throughout the 12-week period

The doctor will evaluate changes in the number and type of acne lesions

Physical examinations and vital signs checks will be performed during visits

Laboratory tests will be conducted at the beginning and end of treatment

4 Quality of life assessment

You will complete a quality of life questionnaire at the start and end of treatment

For participants aged 9-16 years, a special children’s version of the questionnaire will be provided

5 Safety monitoring

The doctor will monitor any side effects throughout the study

Local skin reactions at the application site will be evaluated

The assessment includes checking for redness, peeling, dryness, stinging, burning, and itching

6 Final evaluation

After 12 weeks, a final assessment of your acne condition will be performed

The doctor will evaluate the overall effectiveness of the treatment

Final laboratory tests and safety assessments will be conducted

Who Can Join the Study?

Must sign an informed consent document before participating in the study
Age must be between 9 years and 50 years
Must have facial acne with the following characteristics:
- For ages 14-50: moderate to severe acne (score 3-4 on doctor’s assessment)
- For ages 9-14: mild to severe acne (score 2 or higher on doctor’s assessment)
- Between 20 and 100 inflammatory spots (red, raised bumps or pus-filled spots)
- Between 20 and 100 non-inflammatory spots (blackheads and whiteheads)
- No more than 1 large, deep acne bump (nodule)
May also have acne on upper body (shoulders, upper back, chest) with:
- Moderate severity (grade 2-3 on doctor’s assessment)
- 20-100 inflammatory spots
- 20-100 non-inflammatory spots
- No more than 1 nodule
- Must be able to reach these areas to apply treatment
Must be able to understand the study requirements and potential risks
For participants under 18, parents or legal guardians must also understand and agree to study requirements
Women who can become pregnant must use effective birth control throughout the study:
- If using hormonal birth control: must be stable for at least 6 months before starting
- If using non-hormonal IUD: must be in place at least 2 months before starting

Who Cannot Join the Study?

Age below 12 years or above 65 years
Pregnant women or those planning pregnancy during the study period
Breastfeeding mothers
History of serious allergic reactions to similar medications
Current use of other acne treatments (medications applied to skin or taken orally)
Presence of other skin conditions that could interfere with evaluating the treatment
Severe or nodular acne (deep, painful bumps under the skin)
History of skin cancer or pre-cancerous lesions
Participation in another clinical trial within the past 30 days
Any significant medical condition that could affect study participation
Unable to follow study procedures or attend scheduled visits
History of poor compliance with medical treatments
Use of medications that could interact with the study treatment
Recent facial procedures including chemical peels or laser 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
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy

Other Sites

Site Name	City	Country
Hospital Sant Joan De Deu Barcelona	Esplugues De Llobregat	Spain
Lukmed 2 Sp. z o.o.	Siedlce	Poland
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.	Nowa Sol	Poland
Silmedic Sp. z o.o.	Katowice	Poland
Vitamed Galaj I Cichomski Sp. j.	Bydgoszcz	Poland
Klinika Ambroziak Sp. z o.o.	Warsaw	Poland
St-Inspire Sp. z o.o.	Mikolow	Poland
Labderm Essence Sp. z o.o.	Ozarowice	Poland
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Universita’ Politecnica Delle Marche	Ancona	Italy
Azienda USL Toscana Centro	Prato	Italy
Centrum Zdrowia Dziecka I Rodziny Im. Jana Pawla II W Sosnowcu Sp. z o.o.	Sosnowiec	Poland
Twoja Przychodnia Poznańskie Centrum Medyczne Sp. z o.o.	Poznan	Poland
Hospital Universitario Virgen De La Victoria	Malaga	Spain
EMC Instytut Medyczny S.A.	Poznan	Poland
Royalderm Agnieszka Nawrocka	Warsaw	Poland
DERMAPOLIS Medical Dermatology Center dr n.med. Edyta Gebska	Chorzow	Poland
Aybpzhl Ootwuruglch Uquqsndnbqtgc Pjqfu	Parma	Italy
Ivoure Iwenmzrd Feandgydvvgno Omgjymhaexa	Rome	Italy
Pcsimmo Sxe z orqf	Katowice	Poland

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	01.09.2024
Poland	Not recruiting	01.09.2024
Spain	Not recruiting	01.09.2024

Trial locations

Investigated drugs:

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

N-Acetyl-GED-0507-34-LEVO gel is a topical medication being tested for the treatment of acne vulgaris (common acne). This gel is designed to be applied directly to the skin once daily. It’s being studied as a new potential treatment option for people suffering from acne breakouts.

The trial also includes a vehicle gel, which is a placebo gel that contains the same base ingredients as the active medication but without the active component. This is used as a control to compare the effectiveness of the actual treatment.

Investigated diseases:

Acne

Acne Vulgaris – A common skin condition that occurs when hair follicles become clogged with oil and dead skin cells. It typically appears as various types of bumps on the skin, including whiteheads, blackheads, pimples, and sometimes deeper cysts or nodules. The condition most commonly affects the face, chest, and back, where the highest concentration of oil glands exists. Acne develops when excess oil production, dead skin cells, and bacteria combine to create inflammation in the pores. The condition usually begins during puberty due to hormonal changes but can affect people of various ages. The severity can range from mild with occasional breakouts to severe with persistent inflammation and larger lesions.

Trial ID:

2023-510339-12-00

Protocol code:

NACGED0507ACN0123A

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of N-Acetyl-GED-0507-34-LEVO gel 5% applied daily for treating acne vulgaris

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