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Contact Information:

Dr Simon Royal
Simon.Royal@nottingham.ac.uk


Mrs Elisha Peers


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Be Part of Research - Trial Details - A study to assess the safety and efficacy of a gel treatment in subjects with acne vulgaris
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A study to assess the safety and efficacy of a gel treatment in subjects with acne vulgaris

Not Recruiting

Open to: All Genders

Age: Mixed

Wellingborough Wirral Leicester Barry Nottingham Birmingham

Medical Conditions

Acne vulgaris

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


This study aims to assess the effectiveness and safety of a gel treatment, in comparison to a placebo gel, applied once daily for 12 weeks in patients with acne vulgaris.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Nov 2024 31 Dec 2025

Participants will be randomly assigned to either the treatment or placebo gel and they will not be made aware of which treatment they have been assigned to. The study will include up to 6 on-site visits over 16 weeks. The visits will last for 1-2 hours and will include some physical assessments and investigations. Patients will have an assessment of acne symptoms and a collection of height, weight, and vital signs. Blood samples will also be collected for safety analysis and patients will also complete a questionnaire which will assess how their condition affects their daily life. Study participants will be required to apply the Investigational Product (gel treatment, either active or placebo) themselves, once daily for the duration of the study period.


Patients aged between 9 and 50 years with acne vulgaris

You can take part if:



You may not be able to take part if:


1. Acne: Patients with a known history of acne persistent and unresponsive to topical and/or oral treatments within 6 months before randomisation, patients with generalised or localised acne forms other than acne vulgaris, or patients with acne requiring systemic treatment.2. Beard and facial/body hair, tattoos: Patients with a beard or who intend to grow a beard and/or to perform a facial tattoo during the study or patients with facial hair or facial tattoos that could interfere with study assessments in the investigator’s opinion. For patients with truncal acne: body hair, tattoos (or who intend to perform them) on the shoulders, upper back or upper anterior chest accessible to self-application of study medication by the patient that may interfere with the study assessments in the investigator’s opinion 3. Skin diseases: Patients with other active skin diseases or active skin infections in the facial or truncal region or any other facial or truncal disease or condition that might interfere with the evaluation of acne or place the patient at unacceptable risk 4. Allergy: Known or suspected hypersensitivity to any active or inactive ingredient in the study medications. Patients with a history of an allergic reaction or significant sensitivity to the formulations’ ingredients 5. Topical therapies: Patients who are currently using, will use during the study, or discontinued less than 4 weeks before study baseline the use of prescribed and/or over-the-counter topical therapies for the treatment of acne, including but not limited to: corticosteroids, antibiotics, azelaic acid, benzoyl peroxide, salicylates, α-hydroxy/glycolic acid, any other topical cosmetic therapy for acne and retinoids on the face/trunk 6. Topical skin care products and procedures: Patients who are currently using, will use during the study, or discontinued less than 4 weeks before study baseline the use of products for facial/truncal application containing glycolic or other acids, masks, washes or soaps containing benzoyl peroxide or salicylic acid, non-mild cleansers or moisturisers containing retinol, salicylic or alpha- or beta-hydroxy acids, facial/truncal procedures such as chemical peel, laser treatment, photodynamic therapy, acne surgery, cryodestruction or chemodestruction, x-ray therapy, intralesional steroids, dermabrasion 7. Phototherapy: Patients who are currently using, will use during the study, or discontinued less than 4 weeks before study baseline phototherapy for the treatment of acne, including but not limited to: UV-A, UV-B, heliotherapy. Patients who have the need or plan to be exposed to artificial tanning devices or excessive sunlight during the study 8. Systemic therapies: Patients who are currently using, will use during the study, or discontinued less than 12 weeks before study baseline the use of systemic therapies for the treatment of acne, including but not limited to: antibiotics, isotretinoin. Other systemic therapy that could affect the patient’s acne (i.e., anabolics, lithium, EGRF inhibitors, iodides, systemic corticosteroids - except inhaled corticosteroids or intrathecal corticosteroids - or other immunosuppressants), in the opinion of the investigator 9. Known systemic diseases that can lead to acneiform eruptions:9.1. Increased androgen production:9.1.1. Adrenal origin: e.g., Cushing’s disease, 21-hydroxylase deficiency9.1.2. Ovarian origin: e.g., polycystic ovarian syndrome, ovarian hyperthecosis 9.2. Cryptococcosis disseminated 9.3. Dimorphic fungal infections 9.4. Behçet’s disease9.5. Systemic lupus erythematosus (SLE) 10. Investigative studies: Participation in the evaluation of any investigational product or device within 24 weeks before study baseline 11. Diseases: Patients with underlying uncontrolled or unstable conditions, which, in the Investigator's opinion, could significantly compromise the patient’s safety and/or place the patient at an unacceptable risk. Any condition that in the investigator’s opinion would make it unsafe for the patient to participate in the study 12. Alcohol and other substance abuse: History of alcohol or other substance abuse within 1 year before screening 13. Communication: Patient(s) and parents/legal guardian(s) (if applicable) unable to communicate or cooperate with the investigator due to e.g., language problems, impaired cerebral function, impaired mental conditions 14. Reliability: Patients who may be unreliable for the study including patients who are unable to return for the scheduled visits 15. Pregnancy*: Pregnant or breastfeeding women or women of childbearing potential who are planning to become pregnant during the study. *For all female patients of childbearing potential, pregnancy test result must be negative at screening.


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Albany House Medical Centre
    3 Queen Street
    Wellingborough
    NN8 4RW
  • FutureMeds Ltd
    45 Bridle Rd Birkenhead
    Wirral
    CH62 6EE
  • Heath Lane Surgery
    Westfield Avenue Earl Shilton
    Leicester
    LE9 7RT
  • The Practice of Health
    31 Barry Road Vale of Glamorgan
    Barry
    CF63 1BA
  • Chilwell Valley and Meadows Practice
    Ranson Road, Beeston
    Nottingham
    NG9 6DX
  • FutureMeds Birmingham
    247-251 Soho Road
    Birmingham
    B21 9RY

This study will help gather further information on the effects of this gel and may offer an alternative treatment for patients suffering from acne vulgaris.
Based on the results from two previous large Phase II studies, the active IMP (N-Acetyl-GED-0507-34-LEVO gel 5% [5 mg/100 mg]), is considered to be safe and well tolerated and there were no significant differences between the proposed pediatric and adult population. In a large randomised double-blind controlled clinical trial (NAC-GED-0507-ACN-01-18), the percentage of patients who had one or more AEs was 19%, 16% and 19% in the NAC-GED 5%, NAC-GED 2% and vehicle groups, respectively.
In general, the administration of the IMP may result in some minor side effects such as an allergic or irritant reaction, which may manifest as itching or redness of the skin with papules and blisters. In rare cases, there may be more generalised dermal sensitisation responses, which improve once the treatment stops. Moreover, as the amount to be applied to the skin is relatively small, no systemic side effects are expected. For those participants who are randomised to receive the vehicle IMP, as their condition will not be treated with an active medication for the duration of the study, their acne symptoms may become worse, stay the same or improve.
In terms of study procedures, blood draws may result in bruising or pain where the sample is taken and in some cases, there is a risk of infection, lightheadedness and/or fainting.
With regard to risks associated with pregnancy and breastfeeding, the safety of the study drug for embryos/fetuses is not fully known. Females who are pregnant or breastfeeding or those who plan to become pregnant during the study period will be excluded from enrollment. Additionally, all females of childbearing potential will be required to undertake a pregnancy test and shall also be required to use an acceptable effective contraceptive method throughout the entire study.
Although acne is not a life-threatening condition, it can be a significant source of distress for patients and can be associated with depression, anxiety and poor self-esteem. Patients will be required to complete either a Dermatology Life Quality Index (DLQI) (age 17 years and older) or a Children’s Dermatology Life Quality Index (C-DLQI) (for 16 years and younger). By completion of these questionnaires, there is a risk that some participants may experience some psychological or emotional stress. Similarly, as there is a chance that participants' acne symptoms may become worse or remain the same during the study, this may also contribute to participants experiencing psychological or emotional stress.
However, the participants' health and wellbeing will be closely monitored during the study and will include the collection of all Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAES), Adverse Drug Reactions (ADRs) and Serious Adverse Events (SAEs). Changes from baseline of vital signs, laboratory tests and local tolerability plus physical examinations and an assessment of the overall application of site irritation will also be conducted as to ensure prompt follow-up with participants if required. Moreover, additional phone calls will be included for all patients aged 9 to <12 years at week 2 and at week 10 of treatment, to ensure that any local tolerability or safety issues are promptly identified. The Investigator will be asked to promptly fill in the eCRF page relating to the phone contact. In case of safety issues, an immediate automatic notification will be sent to the Data Safety Monitoring Board (DSMB). A DSMB will also be established to undertake periodic risk-benefit assessments during the clinical trial. Participants who complete 12 weeks of treatment will also be eligible to continue treatment with NAC-GED-0507-34-Levo 5% gel in a separate open-label long-term study (GEDACNE-LT).
The study will include up to six on-site visits over a duration of 16 weeks. The visits will last for 1-2 hours and will include some physical assessments and investigations. Participants will be appropriately reimbursed for any travel expenses and will be made fully aware of the commitment required prior to consenting. At one selected site in the UK, participants will also have the option to consent to the collection of photographic scar monitoring of which images of the participant's face will be shared: internally (to the attention of PPM Services’ collaborators) and/or externally (to the attention of the public and/or health care professionals during any event and/or manifestation whatsoever). This type of assessment has the potential to cause some emotional stress however, information will be provided to participants via a participant information sheet in a way that enables them to clearly understand what is involved in the study, should they consent to take part.
Taking into account these risks and benefits, the performance of the trial can be considered low risk for all ages considered, since the expected benefits appear greater at present than the risks for the volunteers.

Dr Simon Royal
Simon.Royal@nottingham.ac.uk


Mrs Elisha Peers



The study is sponsored by PPM Services S.A and funded by PPM Services S.A.



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Read full details for Trial ID: ISRCTN18067422

Or CPMS: 60042

Last updated 04 February 2026

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