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.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Laboratorios Ojer Pharma S.L.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

14 Jan 2020 → ongoing

Decision date (initial)

2024-09-20

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Laboratorios Ojer Pharma, S.L.

External identifiers

EU CT number

2024-515667-60-00

EudraCT number

2019-002285-12

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

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.

Secondary objectives 5

1. 1. To evaluate the reduction in the number of AK lesions from baseline to weeks 8 and 16 in subjects treated with Keramod® Gel versus Aldara® Cream.
2. 2. 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 (100% reduction of lesions) at weeks 8 and 16.
3. 3. To evaluate the safety of the topical treatment of Keramod® Gel versus Aldara® Cream.
4. 4. To evaluate the treatment tolerance and patient acceptance of the treatment in subjects treated with Keramod® Gel versus Aldara® Cream.
5. 5. To evaluate the adherence to treatment in subjects treated with Keramod® Gel versus Aldara® Cream.

Conditions and MedDRA coding

Actinic keratosis

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. 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. 2. Man or woman aged over 18.
3. 3. Women either must be 1 year postmenopausal, surgically sterile, or agree to use a medically accepted form or birth control.
4. 4. Free of any significant findings (e.g. tattoos) in the potential application site area.
5. 5. Any skin type or race, providing the skin pigmentation will allow discernment.
6. 6. Must be willing to comply with the contraception requirements as defined in Section 6.2.4.
7. 7. Signature of the informed consent form.
8. 8. Patients with the ability to understand and fulfil the study requirements.
9. 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.

Exclusion criteria 15

1. 1. Basal cell or squamous cell carcinoma, or other possible confounding skin conditions (on face and scalp), in the treatment area.
2. 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. 3. History of cutaneous hyperreactivity or irritation to topical products.
4. 4. Engaging in activities involving excessive or prolonged exposure to sunlight.
5. 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. 6. Currently using or have used systemic steroids 2 months prior to study.
7. 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. 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. 9. History of allergy or sensitivity to imiquimod or related compounds or other components of the formulation.
10. 10. Receiving immunosuppressive medication.
11. 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. 12. Mentally incapacitated patients.
13. 13. Current history or history of drug or alcohol abuse in the last 3 years prior to enrollment.
14. 14. Exposure to a product under investigation in the last 3 months prior to enrollment.
15. 15. Known to be affected by porphyria.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Complete clearance of AK lesions, defined as a count of zero AK lesions at week 24 since the first treatment dose.

Secondary endpoints 6

1. 1. Partial and complete clearance rate of AK lesions at the end of first and second cycles: Week 8 (end of first cycle treatment period; visit 3) and Week 16 (end of second cycle treatment period; visit 5).
2. 2. Tolerance and acceptability of the treatment by the study subject assessed by the Treatment tolerance and satisfaction questionnaire.
3. 3. Evaluation of adherence by Treatment Adherence Questionnaire.
4. 4. Rate of subjects who complete one treatment cycle.
5. 5. Rate of subjects who complete two treatment cycles.
6. 6. Severity and frequency of associated adverse events/serious adverse events (AEs/SAEs).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Laboratorios Ojer Pharma S.L.

Sponsor organisation

Laboratorios Ojer Pharma S.L.

Address

Avenida De Pio XII 4 Piso 1 A

City

Pamplona

Postcode

31007

Country

Spain

Scientific contact point

Organisation

Laboratorios Ojer Pharma S.L.

Contact name

Clinical Development Manager

Public contact point

Organisation

Laboratorios Ojer Pharma S.L.

Contact name

Clinical Development Manager

Third parties 2

Locations

1 EU/EEA country · 5 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Temporary halts 1 · Art. 38 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications