Study to compare efficacy and safety between two treatments for actinic queratosis

Phase 1

• Conditions: Actinic Keratosis; MedDRA version: 18.0Level: PTClassification code 10000614Term: Actinic keratosisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2015-002408-97-ES
• Lead Sponsor: Dr. Carlos Serra

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-05
• Last Update Posted: 6 February 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Eligible patients may present at least 5 QA in two symmetrical areas of the face or the scalp. Can not be significant differences in the number QAs between the two treatment areas.

1. Patients older than 18 years and able to give informed consent.
2. Patients must have at least 5 QA in two symmetrical areas of the face or the scalp.
3. Patients must no use solar protection creams or other creams (retinoic, hydroxiacids, emollients, topic antibiotics) on the treatment area during the study time.
4. Patients must agree to postpone the treatment of the other actinic keratosis lesions close to the treatment area.
5. Patients must agree going to the scheduled visits where they have to complete a form with epidemiology aspects, baseline characteristics, and satisfaction with the treatment received and taking pictures of the treatment area on each visit.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

Perioral and periocular areas of the face will be discarded as treatment zones. Patients with previous treatment with photodynamic therapy in the face or the scalp for any lesion. Patients with previous treatment for actinic keratosis in the previous 3 months, patients with inmunosuppression treatment, and patients with inherited diseases which can predispose to cutaneous cancer (Gorlin syndrome, xeroderma pigmentosum.
1. Patients who have clinical evidence of inmunosuppression, unstable cardiovascular diseases, haematological, hepatic, neurological, renal or endocrine diseases. Patients with stables medical conditions like high blood pressure. diabetes mellitus, hypercholesterolemia, etc. can be included in the study.
2. Patients who suffer form any dermatological disease in the treatment zone or around it.
3. Patients who have received previous treatment with photodynamic therapy in the selected areas.
4. Patients who have alcohol or drug dependency.
5. Being currently participating in other studies
6. Patients who have received any of the following treatments in less time than indicated:
- Systemic chemotherapy, in the last 6 months
- Systemics retinoids, interferon, inmunomodulators or inmunosuppressors, cytotoxic agents, systemic corticoids, in the last month
- PUVA, UVB, ablative lasers, dermabrasion, chemical peelings, in the last 6 months
- Topic retinoids, topic 5-fluorouracil, in the last month.
- Cryotherapy, surgical extirpation, curettage, topic corticoids, in the last month

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified