Efficacy and Safety of Treatment of Actinic Keratoses With Photodynamic Therapy Between MAL Cream and ALA Gel

NCT02647151 | Unknown Phase 4

• 2 other identifiers: MALvsALA2015-002408-97
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Photodynamic therapy technique (PDT) is a conventional technique which is performed applying the product under occlusion lesions, let it incubate for 3 hours and then exposed skin to a light source, usually red. The conclusions of efficacy, tolerance and satisfaction that today are known about PDT with MAL, but not with ALA, which is a new photosensitizer indicated for Actinic Keratoses. The pharmaceutical form of ALA is a gel, which gives a hypothetical better penetration and consequently it is more effectively.

Conditions

Actinic Keratosis

Keywords

Acid Methyl Aminolevulinate (MAL); Aminolevulinic Gel (ALA) and Actinic Keratosis

Outcome Measures

Primary Outcomes (1)

• Comparison of MAL with the new BF -200 ALA photosensitizer in actinic keratosis. The Immediate and Delayed Local Reaction and Tolerance will be measured to compare MAL and ALA.

  The main objective of this study is to compare the MAL with the new BF -200 ALA photosensitizer in terms of local reaction and tolerance for the treatment of actinic keratosis . First of all, the immediate local reaction to the lighting may include a greater or less erythema, inflammation and edema. It is scored on a scale of 0-10 where 0 is normal skin without local reaction and 10 is a maximum local reaction. The delayed local reaction is defined by the presence in different degrees of erythema, swelling, edema, pustules and scabs. They are also marked from 0 to 10 where 0 is normal skin without reaction and 10 for local maximum reaction. On the other hand, tolerance will be measured by the number, frequency and grade of reported adverse events in patients.

  1 month

Secondary Outcomes (1)

• Comparison of the clinical response measured by the efficacy and characteristics of fluorescence emission between the two photosensitizers. Partial and total response will be defined with ≥75% (partial response) and 100% (complete response.)

  1 month

Study Arms (2)

METHYLAMINOLEVULINATE HYDROCHLORIDE

ACTIVE COMPARATOR

METHYLAMINOLEVULINATE HYDROCHLORIDE (MAL)cream 160mg/g. Intervention: Just one application of the product in the actinic keratosis lesions before the photodynamic therapy

Drug: METHYLAMINOLEVULINATE HYDROCHLORIDE; Drug: AMINOLEVULINIC ACID HYDROCHLORIDE

AMINOLEVULINIC ACID HYDROCHLORIDE

EXPERIMENTAL

AMINOLEVULINIC ACID HYDROCHLORIDE (ALA) gel 78mg/g. Intervention: Just one application of the product in the actinic keratosis lesions before the photodynamic therapy

Drug: METHYLAMINOLEVULINATE HYDROCHLORIDE; Drug: AMINOLEVULINIC ACID HYDROCHLORIDE

Interventions

METHYLAMINOLEVULINATE HYDROCHLORIDE DRUG

This is an intrapatient randomized clinical trial. All patients participating in the trial will receive both, experimental and control treatment, randomization will be used to determine side (right or left for treatment). Three visits will be scheduled. In the first visit epidemiological data will be collected , Actinic Keratoses are counted and drawn in a transparent template and also a photograph of each side. In that first visit treatment the PDT will be also performed, the degree of fluorescence, the pain and the degree of immediate local reaction will be measured. skin after PDT. In the second visit, to be held at 2 or 3 days, the delayed local reaction degree will be assessed. And in the third visit, held a month of PDT the clinical response and patient satisfaction will be assessed.

Also known as: MAL

AMINOLEVULINIC ACID HYDROCHLORIDE; METHYLAMINOLEVULINATE HYDROCHLORIDE

AMINOLEVULINIC ACID HYDROCHLORIDE DRUG

This is an intrapatient randomized clinical trial. All patients participating in the trial will receive both, experimental and control treatment, randomization will be used to determine side (right or left for treatment). Three visits will be scheduled. In the first visit epidemiological data will be collected , Actinic Keratoses are counted and drawn in a transparent template and also a photograph of each side. In that first visit treatment the PDT will be also performed, the degree of fluorescence, the pain and the degree of immediate local reaction will be measured. skin after PDT. In the second visit, to be held at 2 or 3 days, the delayed local reaction degree will be assessed. And in the third visit, held a month of PDT the clinical response and patient satisfaction will be assessed.

Also known as: ALA

AMINOLEVULINIC ACID HYDROCHLORIDE; METHYLAMINOLEVULINATE HYDROCHLORIDE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient over 18 years old and capable of giving informed consent.
• \. Provide at least 5 QA in two symmetrical areas of the face or scalp.
• \. Accept the abandonment of sun creams and other creams (retinoic hydroxy acids, emollients, Topical Antibiotics ) in the treatment area during the time of the study.
• \. Accept that it will postpone the treatment of other actinic keratosis close to treatment area.
• \. Accept to go to scheduled visits. They should answer a questionnaire about epidemiology, history and treatment satisfaction. They will accept a photo of treatment area at each visit.

You may not qualify if:

• Have any dermatological disease on the treatment zone or around it.
• Patients who have previously been treated with therapy Photodynamic in targeted areas.
• Patients with alcohol or drug dependence.
• Patients who are currently participating in other studies.
• Patients who have received any of the following medications at a time less than the indicated:
• Systemic chemotherapy in the last 6 months.
• Retinoids systemic , interferon , immunomodulatory or immunosuppressive , cytotoxic including agents , corticosteroids systemic , in the last month .
• Ultraviolet A light, Ultraviolet B light, ablative laser, dermabrasion, chemical peels, in the last 6 months.
• Topical retinoids , topical 5 -fluorouracil in the last month.
• Cryotherapy , surgical excision, curettage, topical corticosteroids in the last month.

Sponsors & Collaborators

• Fundación Instituto Valenciano de Oncología: lead

Study Sites (1)

Fundación instituto valenciano de Oncología

Valencia, Valencia, 46009, Spain

RECRUITING

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Aminolevulinic Acid

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Carlos Serra

  Servicio Dermatologia FIVO

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Federico Nepote

CONTACT

0034 93 434 44 12; investigacion@mfar.net

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2015
• First Posted: January 6, 2016
• Study Start: December 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: January 6, 2016

Record last verified: 2016-01

Locations

ES (1)