A study to evaluate Adex Gel in the treatment of actinic keratosis
| ISRCTN | ISRCTN11929806 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11929806 |
| Integrated Research Application System (IRAS) | 371545 |
| Central Portfolio Management System (CPMS) | 74092 |
| Protocol number | DENI-04 |
| Sponsor | Dermal Laboratories Ltd |
| Funder | Dermal Laboratories Ltd |
- Submission date
- 19/06/2026
- Registration date
- 22/06/2026
- Last edited
- 22/06/2026
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and study aims
The study aims to improve understanding of how well Adex Gel works in treating actinic keratosis (AK), a common skin condition caused by long-term sun exposure. Around 65 adults aged 18 years or older will take part through GP practices in England. Researchers will assess changes in the participants skin condition over a period of 12 weeks, using a validated scoring system call the Actinic Keratosis Area and Severity Index (AKASI).
Who can participate?
Patients aged 18 years and older diagnosed with AK.
What does the study involve?
Participants will be asked to apply the study product, Adex Gel, three times daily. The study involves 4 visits to a GP Centre over a 12-week period, where the doctor will assess the participants skin condition and the participant will be asked to complete some questionnaires on their skin condition and opinion of Adex Gel. The participant will also complete a Diary throughout the study duration to record all applications of Adex Gel.
What are the possible benefits and risks of participating?
Participants may benefit from receiving a treatment that improve their skin condition. The study may also help improve care for future patients with actinic keratosis. As the treatment is already approved , the risks are those normally linked with this product. These may include localised skin reactions upon application, such as redness, irritation, or tingling.
Where is the study run from?
The study is being carried out in NHS GP practices across England.
When is the study starting and how long is it expected to run for?
June 2026 to March 2027.
Who is funding the study?
Dermal Laboratories, UK.
Who is the main contact?
Miss Erika Houston, deni04@o4research.com
Contact information
Scientific, Principal investigator
University of Nottingham Health Service
Cripps Health Centre
University Park
Nottingham
NG7 2QW
United Kingdom
| Phone | +44 0115 822 7979 |
|---|---|
| simon.royal@nhs.net |
Public
O4 Research Ltd, Innovation Centre, Queen’s Road, Titanic Quarter
Belfast
BT3 9DT
United Kingdom
| Phone | +028 9024 4764 |
|---|---|
| deni04@o4research.com |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | N/A: single arm study |
| Masking | Open (masking not used) |
| Control | Uncontrolled |
| Assignment | Single |
| Purpose | Post market clinical follow-up study |
| Scientific title | DENI-04: A PMCF study to evaluate the clinical performance and safety of Adex Gel at 12 weeks in patients with dry and inflamed skin presenting with actinic keratosis (AK) |
| Study acronym | DENI-04 |
| Study objectives | This is a post market clinical follow-up study of an already marketed CE-marked medical device (Adex Gel) used within its certified marketing authorisation. The aim is to better understand how well Adex Gel works in treating the dry and inflamed skin associated with AK. The primary objective is to evaluate the performance of Adex Gel in the treatment of AK at 12 weeks as measured by AKASI. Secondary Objectives: • To evaluate the short-term performance of Adex Gel in the treatment of AK at 4 and 8 weeks as measured by AKASI • To assess the change in the number and severity of AK lesions present on the head, ears and scalp at 4, 8 and 12 weeks • To evaluate investigators’ overall assessment of treatment performance and satisfaction with outcomes • To assess the change in AK symptoms from baseline to Week 12 • To evaluate participants’ overall assessment of treatment performance and satisfaction • To evaluate participants’ treatment compliance with Adex Gel Safety Objective: • To evaluate the safety and tolerability of Adex Gel in the treatment of AK |
| Ethics approval(s) |
Approved 15/06/2026, London - Harrow Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 020 7104 8000; harrow.rec@hra.nhs.uk), ref: 26/PR/0624 |
| Health condition(s) or problem(s) studied | Actinic keratosis |
| Intervention | All participants will receive Adex Gel, and will be asked to apply the gel three times daily for 12 weeks. Participants will attend 4 study visits at baseline, 4, 8 and 12 weeks. |
| Intervention type | Drug/Device |
| Phase | Phase III/IV |
| Drug / device / biological / vaccine name(s) | Adex Gel |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 31/03/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 110 Years |
| Sex | All |
| Target sample size at registration | 65 |
| Key inclusion criteria | A patient must meet all the following conditions to be included in the study: 1. Patient must voluntarily sign and date an informed consent form, approved by a Research Ethics Committee (REC), prior to the initiation of any screening or study specific procedures 2. Adult patient aged ≥18 years 3. Fitzpatrick Skin Phototype I, II, or III (Light to medium skin types characterised by a tendency to burn or sunburn, with limited to moderate tanning ability) as confirmed by the Investigator 4. Has multiple (>1) visible, discrete, AK lesions clinically typical of Olsen grade I or II on any skin areas above the neck 5. Has an AKASI score of between ≥0.8 to ≤6.8 6. Willing to avoid prolonged direct sun exposure, tanning booths, sunlamps, or other UV light sources on the treatment area during the study period 7. Willing to refrain from taking vitamin B3 supplements or oral niacinamide/nicotinamide supplements during the study period 8. Willing and able to understand and comply with all study requirements 9. Willing to avoid the use of new facial personal care products (e.g., make-up, soaps, toners or moisturisers) or change any currently used brands during the study period 10. Patient must be free from any other clinically significant dermatological conditions (other than AK) that may interfere with the study evaluations 11. Patient must be sufficiently proficient in the English language to understand and comply with study |
| Key exclusion criteria | A patient will not be permitted to enter the study if any of the following apply: 1. Has a pre-existing facial or scalp dermatologic condition, including those that may be inactive or dormant (e.g., acute skin inflammation, atopic dermatitis, eczema, rosacea, psoriasis, severe acne, seborrheic dermatitis, peri-oral dermatitis, post inflammatory hyperpigmentation or other hyperpigmentation, history of erosive pustular dermatosis) that could interfere with the study evaluations, lesion counts, confound results, or impact patient safety, as assessed and confirmed by the investigator 2. Has very thick, hyperkeratotic, hypertrophic, atypical, or rapidly changing AK lesions (Olsen grade III) 3. Has used topical treatments for AK in the treatment area (e.g., 5-fluorouracil, imiquimod, diclofenac, tirbanibulin, salicylic acid, corticosteroids or retinoids) within 30 days prior to screening 4. Has used chemical peel, dermabrasion, laser therapy, PUVA (psoralen plus ultraviolet A) therapy or UVB (Ultraviolet B) therapy within 6 months prior to screening 5. Has used immunomodulators, systemic chemotherapeutics or immunosuppressive therapies, interferon, oral/injectable corticosteroids, oral retinoids, or cytotoxic drugs within 30 days prior to screening 6. Has diagnosed basal cell carcinoma, squamous cell carcinoma or melanoma 7. Has a history of malignancy not in remission for ≥5 years 8. Has symptoms of clinically significant illness that may influence their participation 9. Has facial hair, abnormal skin pigmentation or body art on the face that may interfere with accurate assessment of AK 10. Has any condition (e.g. xeroderma pigmentosum (XP), albinism, or Bloom’s syndrome) that, in the opinion of the investigator, may influence treatment evaluation or other assessments 11. Has participated in a clinical trial/investigation involving an investigational product (investigational medicinal product/medical device) within 30 days prior to screening 12. Has known hypersensitivity, intolerance, or allergy to Adex Gel or any of its components 13. Is an employee of the investigative site, Sponsor or Clinical Research Organisation (CRO), or a first degree relative of such employees 14. Has an inability to communicate adequately (e.g., language barriers, or neurodevelopmental disorders) in the opinion of the investigator 15. Any other condition that, in the opinion of the investigator, renders the participant unfit for study participation |
| Date of first enrolment | 30/06/2026 |
| Date of final enrolment | 31/12/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
University Park
Nottingham
NG7 2QW
England
Burbage
Hinckley
LE10 2SE
England
Skegby
Sutton-in-ashfield
NG17 3EE
England
Alton
GU34 1RJ
England
Plymouth
PL7 2QP
England
Chilwell
Beeston
Nottingham
NG9 6DX
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
22/06/2026: Study's existence confirmed by Health Research Authority (HRA) (UK).
