BridgeMD
An exploratory, multicenter, randomized, open-label with blind evaluation, active controlled study to evaluate the safety and efficacy of Keramod (imiquimod 50 mg/g, Gel) compared with Aldara (imiquimod 50 mg/g, Cream) for the treatment of actinic keratosis in adults.
EU CTIS ID: 2024-515667-60-00
What this study is testing
To evaluate the efficacy of Keramod® Gel (imiquimod 5%, Gel) versus Aldara® Cream (imiquimod 5%, cream), in the treatment of AK in terms of complete clearance of AK lesions at week 24 since the first treatment dose.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Patients must have 4 to 8 clinically diagnosed, non-hyperkeratotic, non-hypertrophic AK lesions within a 25 cm2 contiguous treatment área on either the face or balding scalp.
- 2. Man or woman aged over 18.
- 3. Women either must be 1 year postmenopausal, surgically sterile, or agree to use a medically accepted form or birth control.
- 4. Free of any significant findings (e.g. tattoos) in the potential application site area.
- 5. Any skin type or race, providing the skin pigmentation will allow discernment.
- 6. Must be willing to comply with the contraception requirements as defined in Section 6.2.4.
You likely can't join if
- 1. Basal cell or squamous cell carcinoma, or other possible confounding skin conditions (on face and scalp), in the treatment area.
- 10. Receiving immunosuppressive medication.
- 11. History of severe cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, metabolic, mental, neurological or any other disease in the last 2 years prior to enrollment that could hinder regular treatment and supervision of the patient and could cause premature withdrawal of the study.
- 12. Mentally incapacitated patients.
- 13. Current history or history of drug or alcohol abuse in the last 3 years prior to enrollment.
- 14. Exposure to a product under investigation in the last 3 months prior to enrollment.
See the full eligibility criteria
- 1. Patients must have 4 to 8 clinically diagnosed, non-hyperkeratotic, non-hypertrophic AK lesions within a 25 cm2 contiguous treatment área on either the face or balding scalp.
- 2. Man or woman aged over 18.
- 3. Women either must be 1 year postmenopausal, surgically sterile, or agree to use a medically accepted form or birth control.
- 4. Free of any significant findings (e.g. tattoos) in the potential application site area.
- 5. Any skin type or race, providing the skin pigmentation will allow discernment.
- 6. Must be willing to comply with the contraception requirements as defined in Section 6.2.4.
- 7. Signature of the informed consent form.
- 8. Patients with the ability to understand and fulfil the study requirements.
- 9. In good health, as confirmed by medical history and physical examination, and free of any clinically significant disease/condition, other than actinic keratosis, that could interfere with the study evaluations.
- 1. Basal cell or squamous cell carcinoma, or other possible confounding skin conditions (on face and scalp), in the treatment area.
- 10. Receiving immunosuppressive medication.
- 11. History of severe cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, metabolic, mental, neurological or any other disease in the last 2 years prior to enrollment that could hinder regular treatment and supervision of the patient and could cause premature withdrawal of the study.
- 12. Mentally incapacitated patients.
- 13. Current history or history of drug or alcohol abuse in the last 3 years prior to enrollment.
- 14. Exposure to a product under investigation in the last 3 months prior to enrollment.
- 15. Known to be affected by porphyria.
- 2. Presence of atopic dermatitis, eczema, psoriasis, rosacea or other possible confounding skin conditions on face or balding scalp even outside of the treatment area.
- 3. History of cutaneous hyperreactivity or irritation to topical products.
- 4. Engaging in activities involving excessive or prolonged exposure to sunlight.
- 5. Receiving systemic cancer chemotherapy, psoralen plus UVA therapy, UVB therapy, laser abrasion, dermabrasion, glycolic acids, or chemical peels 6 months prior to study entry.
- 6. Currently using or have used systemic steroids 2 months prior to study.
- 7. Currently using or have used on the treatment area over-the-counter retinol products, corticosteroids, cryosurgery, curettage, 5-fluorouracil, or other topical actinic keratosis treatments 28 days prior to randomization.
- 8. Females who are pregnant, breastfeeding or planning to become pregnant during the first administration of IMP until 6 months after the last dose of IMP.
- 9. History of allergy or sensitivity to imiquimod or related compounds or other components of the formulation.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.