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Actinic KeratosisPhase 2NCT02799030

A Clinical Trial of Topical Photodynamic Therapy With 5-aminolevulinic Acid for the Treatment of Actinic Keratosis

A Phase 2 study testing BF-200 ALA 1%, BF-200 ALA 3% and BF-200 ALA 10% in people with Actinic Keratosis, run by Biofrontera Bioscience GmbH.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This was a placebo controlled, double blind, randomized phase II dose-response study to evaluate the efficacy and safety of BF-200 ALA (containing the active ingredient 5 - aminolevulinic acid- ALA) used with photodynamic therapy (PDT) in patients with actinic keratosis (AK). Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Actinic Keratosis
What is being tested?
BF-200 ALA 1%, BF-200 ALA 3% and BF-200 ALA 10%
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
105 participants
Where
No sites listed yet
Study dates
Oct 2006to Mar 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subjects were willing and able to sign the informed consent form.
  • Men and women aged between 18 and 85 years.
  • Had a general good and stable health condition as confirmed by a physical examination and by medical history.
  • The subjects accepted to abstain from sunbathing and the solarium during the study.
  • The subjects had at least 3 but not more than 10 clinically confirmed AK target lesion of mild to moderate intensity within the face or bald scalp (excluding eyelids, lips and mucosa), i.e. AK grade I and II. Grade I AK lesions presented as flat, pink maculae without signs of hyperkeratosis and erythema.
  • The AK lesions had to be discrete and quantifiable; the distance from one lesion to its neighbour lesion was greater than 1.5 cm.
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  • The diameter of each AK lesion was not less than 0.5 cm and not greater than 1.5 cm.
  • The subjects were free of any significant physical abnormalities (e.g., tattoos, dermatoses) in the potential treatment area that could cause difficulty with examination or final evaluation.
  • The subjects were willing to stop using moisturizers and any other topical treatments with anti-aging products, vitamin A, vitamin C, and/or vitamin E containing ointments and creams, and green tea preparations during the study within the treatment area. Sunscreens was allowed, but was not to be applied in the treatment area within approximately 24 hours of a clinic visit with lesion count.
  • Only women of childbearing potential who used a highly effective method of contraception and who had a negative serum pregnancy test were allowed to participate in this study.

Who cannot join

  • Had a known hypersensitivity to ALA.
  • Had received any other medication known to affect AK 3 months before or during the study.
  • Were under immunosuppressive therapy.
  • Suffered from porphyria.
  • Showed hypersensitivity to porphyrins.
  • Suffered from photodermatoses.
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  • Had inherited or acquired coagulation defects.
  • Received medication with hypericin or systemically acting drugs with phototoxic or photoallergic potential within 8 weeks prior to treatment with study drug and PDT
  • Had evidence of clinically significant, unstable medical conditions such as
  • a metastatic tumour or a tumour with a high probability of metastatic spread
  • cardiovascular (NYHA class III, IV)
  • immunosuppressive
  • haematological, hepatic, renal, neurological, endocrine
  • collagen-vascular
  • gastrointestinal.
  • Subjects with clinically stable medical conditions including, but not limited to the following diseases were allowed to be included into the study, if the medication taken for the treatment of the disease did not match the criteria of the excluded or disallowed medications listed in points 11 and 12 below:
  • controlled hypertension
  • diabetes mellitus type II
  • hypercholesterinaemia
  • osteoarthritis
  • Had currently other malignant or benign tumours of the skin within the treatment area (e.g., malignant melanoma, basal cell carcinoma, squamous cell carcinoma).
  • Had received the following treatments for any indication in the treatment area within the designated time period before PDT treatment with ALA:
  • Topical steroids - 4 weeks
  • Topical retinoids - 6 weeks
  • Topical diclofenac preparations - 6 weeks
  • Topical 5-fluorouracil preparations - 6 weeks
  • Topical immunomodulators - 6 weeks
  • Surgical excision (except biopsy for diagnostic confirmation) - 6 weeks
  • Curettage - 4 weeks
  • Cryo-, thermo- or chemodestruction - 6 weeks
  • PDT - 6 weeks
  • Therapeutic UV-Radiation - 6 weeks
  • Had received the following systemic treatments within the designated period before PDT treatment with ALA:
  • Interferon - 6 weeks
  • Immunomodulators or immunosuppressive therapies - 10 weeks
  • Cytotoxic drugs - 6 months
  • Investigational drugs - 8 weeks
  • Drugs known to have major organ toxicity - 8 weeks
  • Corticosteroids (oral or injectable) - 6 weeks
  • Inhaled corticosteroids (>1200 µg/day for beclomethasone, or >600 µg/day for fluticasone) - 4 weeks
  • A previous treatment with ALA.
  • Known allergy to polysorbate 80, caprylic/capric acid triglycerides, isopropyl alcohol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, propylene glycol, methyl parahydroxybenzoate, or propyl parahydroxybenzoate.
  • Were known to be pregnant or lactating (currently or within the past 3 months).
  • Had any dermatological disease in the treatment area or surrounding area that might be exacerbated by treatment with topical ALA or cause difficulty with examination (e.g. psoriasis, eczema).
  • Show cornu cutaneum like alterations of the skin in the face or on the bald scalp (target area).
  • Were currently or within the past 8 weeks participating in another clinical study.
  • Had active chemical dependency or alcoholism as assessed by the investigator.
  • Topical steroids for the treatment of dermatological diseases (e.g. atopic dermatitis, lichen planus) in locations other than in treatment area were allowed during the study provided the amount used did not exceed 2 mg fluorinated steroids daily for more than 1 week or 6 mg beclomethasone for more than 1 week.

About this study

Official title: A Randomized Placebo-controlled Clinical Trial of Topical Photodynamic Therapy With 5-aminolevulinic Acid for the Treatment of Actinic Keratosis

This was a placebo controlled, double blind, randomized phase II dose-response study to evaluate the efficacy and safety of BF-200 ALA (containing the active ingredient 5 - aminolevulinic acid- ALA) used with photodynamic therapy (PDT) in patients with actinic keratosis (AK).

Read the detailed description

The study was performed to define the effective therapeutic dose of the active pharmaceutical ingredient (ALA) in a nanoemulsion formulation in the treatment of actinic keratosis (AK) with topical PDT and to assess the efficacy of topical PDT with a new nanoemulsion formulation of ALA in the treatment of AK. The efficacy of BF-200 ALA was calculated by the AK clearance rate, defined as the proportion of AK lesions showing complete remission 12 weeks after PDT treatment.

Subjects of two study centres provided plasma and urine samples for the quantification of ALA and its metabolite, the active photosensitizer protoporphyrin IX (PpIX).

Being tested
BF-200 ALA 1%, BF-200 ALA 3%, BF-200 ALA 10%
Medical subject headings
Keratosis, Actinic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BF-200 ALA 1%Drug

    topical treatment for photodynamic therapy combining drug application and after 3 h of drug incubation subsequent illumination with a broad spectrum light source .

  • BF-200 ALA 3%Drug

    topical treatment for photodynamic therapy combining drug application and after 3 h of drug incubation subsequent illumination with a broad spectrum light source .

  • BF-200 ALA 10%Drug

    Also called Ameluz

    topical treatment for photodynamic therapy combining drug application and after 3 h of drug incubation subsequent illumination with a broad spectrum light source .

Study groups in NCT02799030
Study groupRoleWhat they receive
BF-200 ALA 0%Placebo comparatorTopical application of matched placebo gel without containing 5-ALA. Application of a 1 mm thick layer covering each lesion and approximately 1 cm of the surrounding margin.
Receives: Drug: BF-200 ALA 1%; Drug: BF-200 ALA 3%; Drug: BF-200 ALA 10%
BF-200 ALA 1%ExperimentalTopical application of BF-200 ALA gel containing 0.78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and approximately 1 cm of the surrounding margin.
Receives: Drug: BF-200 ALA 1%
BF-200 ALA 3%ExperimentalTopical application of BF-200 ALA gel containing 3.8 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and approximately 1 cm of the surrounding margin.
Receives: Drug: BF-200 ALA 3%
BF-200 ALA 10%ExperimentalTopical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and approximately 1 cm of the surrounding margin.
Receives: Drug: BF-200 ALA 10%

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total clearance rate of AK lesions

    Total clearance rate of all AK lesions, defined as the percentage of baseline lesions within the target treatment areas showing complete remission at week 12 post treatment.

    Measured: 12 weeks after photodynamic therapy (PDT)

Secondary outcomes (7)

  1. Percentage of subjects totally cleared

    Percentage of subject totally cleared, i.e. with complete clearance of all lesions treated 12 weeks after PDT.

    Measured: 12 weeks after PDT

  2. Reduction of Total Lesion Area

    The reduction of AK lesion area per patient assessed by comparing the total lesion area pre-treatment (at baseline before PDT) and 12 weeks post-treatment

    Measured: 12 weeks after PDT

  3. Reduction of Lesion Size

    The reduction of the total AK lesion size results from the sum of all single lesion areas by comparing the total lesion size pre-treatment (at baseline before PDT) and 12 weeks post-treatment.

    Measured: 12 weeks after PDT

  4. Overall Cosmetic Outcome

    Overall Cosmetic Outcome 12 weeks after PDT. The cosmetic outcome at the end-of-study visit will be calculated on the basis of the skin quality assessment (skin surface, hyperpigmentation, hypopigmentation, mottled or irregular pigmentation, degree of scarring, and atrophy. The cosmetic outcome is rated as very good if the sum score of the previously mentioned ratings (all ratings for each sign added up) at a given visit has improved by at least 2 points as compared to baseline; the cosmetic outcome is rated as good if the sum score at a given visit has improved by at least 1 point as compared to baseline; the cosmetic outcome is rated as satisfactory if the sum score at a given visit is identical to the one at baseline; the cosmetic outcome is rated as unsatisfactory if the sum score at a given visit has worsened by 1 point compared to baseline, the cosmetic outcome is rated as impaired if the sum score at a given visit has worsened by at least 2 points compared to baseline.

    Measured: 12 weeks after PDT

  5. Local Skin Reactions

    Local skin reactions in the treatment area as assessed by the investigator during PDT

    Measured: during anf after PDT [3h - 4 h]

  6. Local discomfort

    Local discomfort or pain reported by the patient during PDT

    Measured: during and after PDT [3h - 4 h]

  7. related Adverse Events (AEs)

    Frequency and extent of related treatment-emerged AEs (TEAEs ) including related serious AEs

    Measured: up to 12 weeks after PDT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2016 (estimated)
  2. Study startOct 2006
  3. Primary completionMar 2007
  4. Study completionMar 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02799030
Sponsor's protocol ID
ALA-AK-CT001
Status last verified
Jun 2016
First submitted
26 May 2016
Last updated
19 Jul 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BF-200 ALA 1%, BF-200 ALA 3% and BF-200 ALA 10% in people with Actinic Keratosis, run by Biofrontera Bioscience GmbH.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 48 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total clearance rate of AK lesions (time frame: 12 weeks after photodynamic therapy (PDT)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02799030.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2016.

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