Duration of Ameluz Application in Acral Actinic Keratoses Response

NCT03963102 | Terminated Phase 4 DMC

• 1 other identifier: PDT AK v1
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

A phase IV study of a single topical application of ALA for 3 hours or 4 hours to AK on acral sites (hands, feet, arms and legs), and subsequent measurement of clinical efficacy with corresponding PpIX fluorescence imaging.

Conditions

Actinic Keratoses; Photodamaged Skin

Keywords

photodynamic therapy

Outcome Measures

Primary Outcomes (1)

• The odds of full clearance of individual lesions in the intervention and control groups will be compared (reported as an odds ratio with 95%CLs).

  Clinical outcome at 3 months of the treated AK lesions on acral sites

  3 months

Secondary Outcomes (5)

• Clearance of lesions on other body sites

  3 months

• Pain Score

  1 week

• Photobleaching

  After data collection is completed, during analysis phase, expected at 12 months.

• PpIX accumulation fluorescence

  After data collection is completed, during analysis phase, expected at 12 months.

• PpIX dissipation fluorescence

  After data collection is completed, during analysis phase, expected at 12 months.

Study Arms (2)

Control Group 3 hours

ACTIVE COMPARATOR

Application of Ameluz for 3 hours.

Drug: Ameluz

Trial Group 4 hours

EXPERIMENTAL

Application of Ameluz for 4 hours.

Drug: Ameluz

Interventions

Ameluz DRUG

Leaving on the gel for 4 hours rather than the standard 3 hours.

Control Group 3 hours; Trial Group 4 hours

Eligibility Criteria

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

You may qualify if:

• Patient has given written informed consent.
• Males and females \> 18 years.
• AK lesions on arms, hands, legs or feet that are practical to treat with PDT.

You may not qualify if:

• Lesions with a clinical diagnosis of Bowen's disease, superficial, morphoeic or nodular basal cell carcinoma, squamous cell carcinoma, or melanoma as they are not the types of lesions required for investigation.
• Any disease which is caused or exacerbated by light, including systemic lupus erythematosus, porphyria, actinic reticuloid or xeroderma pigmentosum. Part of the clinical study will be the use of light-imaging system so any condition, which is sensitive to such instruments, will be excluded.
• Males or females of childbearing potential, who are not practicing adequate contraceptive precaution. Female patients should practice strict birth control (oestrogen-containing oral contraceptives or an IUD) throughout the trial. Only post-menopausal women (12 months or more with no menses) and women who have had a hysterectomy are exempt from the requirements to use birth control. Male patients should also use adequate contraception for the duration of the trial.
• Pregnant or lactating females
• Treatment in the previous 45 days with any cryotherapy, topical treatments for AK, experimental compound, an iron chelating agent, radiotherapy, chemotherapy or with any light activated therapy or any other medication, which may render the patient light sensitive (e.g. PUVA).
• Photodynamic therapy treatment in the previous 90 days.
• Co-existing ophthalmic disease likely to require slit lamp examination within 30 days of PDT treatment.
• Known allergies to porphyrins, peanut, soya or excipients.
• Patients not able to comply with study requirements.
• Patients on immunosuppression medication.

Sponsors & Collaborators

• Royal Cornwall Hospitals Trust: lead

Study Sites (1)

Royal Cornwall Hospital

Truro, Cornwall, TR1 3LQ, United Kingdom

Location

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 Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor is blinded to whether the patient is in the control or trial group when assessing the primary outcome at 3 months. There will be an additional member of staff present to ensure blinding is not revealed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised control study, prospective, assessor blinded.

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: May 24, 2019
• Study Start: October 30, 2019
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: July 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)