Actinic KeratosisPhase 3NCT02799082

Evaluation of Efficacy and Safety of BF-200 ALA Used With Photodynamic Therapy in Patients With Actinic Keratosis.

A Phase 3 study testing BF-200 ALA 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.

Trial summary

The aim of the study was to evaluate the efficacy and safety of BF-200 ALA (Ameluz) used with photodynamic therapy (PDT) in patients suffering from actinic keratosis. 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
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 122 participants
Where: No sites listed yet
Study dates: Dec 2007to Oct 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Subjects were willing and able to sign informed consent form.
Men and women aged between 18 and 85 years inclusive.
Subjects had a general good and stable health condition as confirmed by a physical examination and by medical history.
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 7, 10, 11 and 12 of the exclusion criteria:
controlled hypertension
diabetes mellitus type II

Show all 19Show fewer

hypercholesterolemia
osteoarthritis
Subjects accepted to abstain from sunbathing and the solarium during the study.
Subjects had at least 4 but not more than 8 clinically confirmed actinic keratosis (AK) target lesions of mild to moderate intensity within the face or bald scalp (excluding eyelids, lips and mucosa), i.e. AK grade I and II according to Olsen et. al. 1991.
To document and confirm the diagnosis of the investigators:
Photodocumentation of a representative lesion had to be evaluated and confirmed by an independent expert.
A pre-study biopsy had to be taken from a second representative AK lesion and was histopathologically evaluated by a dermato-pathological expert.
If the evaluation of the photo by the independent reviewer could not confirm the diagnosis of the investigator, then the biopsy result decided whether the subject was eligible for the study.
The AK lesions had to be discrete and quantifiable; the distance from one lesion to its neighbor lesion was greater than 1.0 cm
The diameter of each AK lesion was not less than 0.5 cm and not greater than 1.5 cm. The size of each baseline AK lesion was recorded by measuring the two largest perpendicular diameters. To describe irregular lesions (ellipsoidal) investigators measured the major and minor axis. Both axes had to be above the minimum of 0.5 cm and less than 1.5 cm.
The subjects were free of any significant physical abnormalities (e.g., tattoos, dermatoses) in the potential treatment area that might 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 were allowed, but were not to be applied in the treatment area within approximately 24 hours before a clinical visit with lesion count.
Women of childbearing potential were only allowed to participate in this study, if they used a highly effective method of contraception and had a negative serum pregnancy test.

Who cannot join

Had known hypersensitivity to 5-aminolevulinic acid (ALA).
Were subjects under immunosuppressive therapy.
Suffered from porphyria.
Showed hypersensitivity to porphyrins.
Suffered from photodermatoses.
Had inherited or acquired coagulation defects.

Show all 34Show fewer

Had received medication with hypericin or systemically acting drugs with phototoxic or photoallergic potential such as psoralens, tetracyclines, nalidixic acid, furosemide, amiodarone, phenothiazines, quinolones, fibrates, or phytotherapy with St. John's wort, arnica, or valerian or topically applied phototoxic substances like tar, pitch, psoralens or some dyes like thiazide, methylene blue, toluidine blue, eosine, Bengal rose, acridine within 8 weeks prior to treatment with study drug and photodynamic therapy (PDT).
Had evidence of clinically significant, unstable medical conditions such as
metastatic tumor or tumor with high probability of metastatic spread
cardiovascular (NYHA class III, IV)
immunosuppressive
hematological, hepatic, renal, neurological, endocrine
collagen-vascular
gastrointestinal
Had currently other malignant or benign tumors of the skin within the treatment area (e.g., malignant melanoma, basal cell carcinoma, invasive squamous cell carcinoma).
Used any topical treatment in the treatment area within 12 weeks before PDT treatment with BF-200 ALA; biopsy taken at the screening visit was allowed.
Used topical treatment with ALA or MAL (methyl-aminolevulinic acid hydrochloride) outside the treatment area during participation in the study.
Systemic treatments of one of the following within the designated period before
PDT with BF-200 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
Methyl-aminolevulinic acid hydrochloride or ALA - 12 weeks
Known allergy against polysorbate 80, caprylic/capric acid triglycerides, isopropyl alcohol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, propylene glycol; sodium benzoate.
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 could be exacerbated by treatment with topical ALA or caused difficulty with examination (e.g. psoriasis, eczema).
Showed 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.
Confirmed diagnosis of HIV.

About this study

Official title: A Randomized, Double-Blind, Phase III Multi-Center Study Evaluating the Safety and Efficacy of BF-200 ALA Versus Placebo in the Treatment of Actinic Keratosis (AK) When Using PDT

The aim of the study was to evaluate the efficacy and safety of BF-200 ALA (Ameluz) used with photodynamic therapy (PDT) in patients suffering from actinic keratosis.

Read the detailed description

The treatment comprised of one PDT session. If 12 weeks after PDT all lesions were cleared the patient entered the follow-up period. In case of remaining lesions or not completely cleared lesions the patient received a second PDT on the same day. The final assessment was performed 12 weeks after the last PDT and the patient moved to the follow-up phase.

Conditions: Actinic Keratosis
Being tested: Vehicle, BF-200 ALA
Medical subject headings: Keratosis, Actinic

What participants receive

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

VehicleDrug
topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation).
BF-200 ALADrug
Also called Ameluz
topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation).

Study groups in NCT02799082
Study group	Role	What they receive
Vehicle	Placebo comparator	Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin. Receives: Drug: Vehicle
BF-200 ALA	Active comparator	Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin. Receives: Drug: BF-200 ALA

What is being measured

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

Total Patient Clearance Rate 12 Weeks After the Last Photodynamic Therapy (PDT)
AK clearance rate, defined as the percentage of subjects with complete remission of all AK lesions in the target area(s) assessed 12 weeks after the last PDT (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment).
Measured: 12 weeks after the last photodynamic therapy (PDT), up to 24 weeks
Total Patient Clearance Rate 12 Weeks After the Last Photodynamic Therapy (PDT)
AK clearance rate, defined as the percentage of subjects with complete remission of all AK lesions in the target area(s) assessed 12 weeks after the last PDT (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment).
Measured: 12 weeks after the last PDT, up to 24 weeks
Total Patient Clearance Rate Treated With Narrow Spectrum Lamp 12 Weeks After the Last Photodynamic Therapy (PDT)
AK clearance rate, defined as the percentage of subjects with complete remission of all AK lesions in the target area(s) assessed 12 weeks after the last PDT (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment).
Analysis was for the subgroup: treated by narrow spectrum lamps only [n=15 (vehicle), n= 31 (BF-200 ALA)]
Measured: 12 weeks after the last PDT, up to 24 weeks
Total Patient Clearance Rate Treated With Narrow Spectrum Lamp 12 Weeks After the Last Photodynamic Therapy (PDT)
AK clearance rate, defined as the percentage of subjects with complete remission of all AK lesions in the target area(s) assessed 12 weeks after the last PDT (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment).
Analysis was for the subgroup: treated by narrow spectrum lamps only [n=13 (vehicle), n= 28 (BF-200 ALA)]
Measured: 12 weeks after the last PDT, up to 24 weeks

Secondary outcomes (11)

Percentage of AK Lesions Showing Complete Remission 12 Weeks After the Last PDT
Percentage of individual lesions completely cleared and with no adherent scaling plaques of AK that were visible any longer 12 weeks after the last PDT (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment); Overall population
Measured: 12 weeks after the last PDT, up to 24 weeks
Percentage of AK Lesions Showing Complete Remission Treated With Narrow Spectrum Lamp 12 Weeks After the Last PDT
Percentage of individual lesions completely cleared and with no adherent scaling plaques of AK that were visible any longer 12 weeks after the last PDT (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment).
for subgroup analysis: patients treated with narrow spectrum lamp only.
Measured: 12 weeks after the last PDT, up to 24 weeks
Change in Total Lesion Size 12 Weeks After the Last PDT
Change in the mean total lesion area 12 weeks per subject after the last PDT compared to baseline (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment).
The outcome measure describes the mean difference between total lesion size at baseline and 12 weeks after the last PDT. Negative values indicate a reduction in the total lesion area size compared to baseline.
Measured: 12 weeks after the last PDT, up to 24 weeks
Change in Total Lesion Area 12 Weeks After the Last PDT (Treated Area Face)
Change in mean total lesion area within the target treatment area per subject 12 weeks after the last PDT compared to baseline (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment). The outcome measure describes the mean difference between total lesion size at baseline and 12 weeks after the last PDT. Negative values indicate a reduction in the total lesion area size compared to baseline.
Subgroup Analysis for patients with lesions located in the face only.
Measured: 12 weeks after the last PDT, up to 24 weeks
Change in Total Lesion Area 12 Weeks After the Last PDT (Treated Area Scalp)
Change in mean total lesion area within the target treatment area per subject 12 weeks after the last PDT compared to baseline (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment). The outcome measure describes the mean difference between total lesion size at baseline and 12 weeks after the last PDT. Negative values indicate a reduction in the total lesion area size compared to baseline.
Subgroup Analysis for patients with lesions located in the scalp only.
Measured: 12 weeks after the last PDT, up to 24 weeks
Subjects With Complete Clearance 12 Weeks After the First PDT
AK clearance rate, defined as the number of subjects with complete remission of all AK lesions assessed at 12 weeks after the first PDT
Measured: 12 weeks after the first PDT
Subjects With Partial Clearance 12 Weeks After the Last PDT
Percentage of subjects with clearance of at least 75% of lesions 12 weeks after the last PDT (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment).
Measured: 12 weeks after the last PDT, up to 24 weeks
Overall Cosmetic Outcome 12 Weeks After the Last PDT
Overall Cosmetic Outcome (CO) 12 weeks after PDT (12 weeks after 1st PDT or 12 weeks after 2nd PDT). The cosmetic outcome at the end-of-study visit was calculated on the basis of skin quality assessment: skin surface, hyperpigmentation, hypopigmentation, mottled/irregular pigmentation, degree of scarring, and atrophy. The CO was rated as very good if the sum score of the previously mentioned ratings (all ratings for each sign added up) has improved by at least 2 points as compared to baseline; the CO was 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 the last PDT, up to 24 weeks
Local Skin Reactions
Local skin reactions observed immediately after illumination by the investigator were documented using different categories (erythema, edema, induration, vesicles, erosion, ulceration, scaling/flanking, scabbing/crusting,weeping/exudates).
Measured: during and after PDT [3h - 4 h]
Discomfort During and After PDT
Local discomfort experienced by the patient after illumination were documented in three categories: itching, burning, pain.
Measured: during and after PDT [3h - 4 h]
Related Adverse Events /AEs)
Related treatment-emerged-adverse events (TEAEs) until 12 weeks after the last PDT (>=5%) TEAEs were reported from the day of the 1st PDT until the end-of-study (clinical part), i.e. 12 weeks after the last PDT (until 12 weeks after the 1st PDT or up to 24 weeks in case a 2nd PDT was applied).
Measured: up to 24 weeks after the 1st PDT

Timeline

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

Dec 2007Oct 2008

First posted14 Jun 2016 (estimated)
Study startDec 2007
Primary completionOct 2008
Study completionOct 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Actinic KeratosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 122 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02799082
Sponsor's protocol ID: ALA-AK-CT003
Status last verified: Apr 2017
First submitted: 27 May 2016
Last updated: 6 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Szeimies RM, Radny P, Sebastian M, Borrosch F, Dirschka T, Krahn-Senftleben G, Reich K, Pabst G, Voss D, Foguet M, Gahlmann R, Lubbert H, Reinhold U. Photodynamic therapy with BF-200 ALA for the treatment of actinic keratosis: results of a prospective, randomized, double-blind, placebo-controlled phase III study. Br J Dermatol. 2010 Aug;163(2):386-94. doi: 10.1111/j.1365-2133.2010.09873.x. Epub 2010 May 28.
PubMed 20518784
Dirschka T, Radny P, Dominicus R, Mensing H, Bruning H, Jenne L, Karl L, Sebastian M, Oster-Schmidt C, Klovekorn W, Reinhold U, Tanner M, Grone D, Deichmann M, Simon M, Hubinger F, Hofbauer G, Krahn-Senftleben G, Borrosch F, Reich K, Berking C, Wolf P, Lehmann P, Moers-Carpi M, Honigsmann H, Wernicke-Panten K, Hahn S, Pabst G, Voss D, Foguet M, Schmitz B, Lubbert H, Szeimies RM; AK-CT002 Study Group; AK-CT003 Study Group. Long-term (6 and 12 months) follow-up of two prospective, randomized, controlled phase III trials of photodynamic therapy with BF-200 ALA and methyl aminolaevulinate for the treatment of actinic keratosis. Br J Dermatol. 2013 Apr;168(4):825-36. doi: 10.1111/bjd.12158.
PubMed 23252768

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingPhase 1
A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BCX17725
Netherton Syndrome
RecruitingPhase 3
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Upper Extremities
Actinic Keratosis
RecruitingPhase 3
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp
Actinic Keratosis
Active, not recruitingPhase 3
A Pilot Clinical Trial Comparing Topical Fluorouracil to Fluorouracil Plus Calcipotriene Field Treatments in Patients With Multiple Actinic Keratoses
Multiple Actinic Keratoses
RecruitingPhase 3
Basal Cell Carcinoma Chemoprevention Trial
Basal Cell Carcinoma

All Actinic Keratosis trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Phase III Multi-Center Study Evaluating the Safety and Efficacy of BF-200 ALA Versus Placebo in the Treatment of Actinic Keratosis (AK) When Using PDT
ClinicalTrials.gov ID: NCT02799082
Acronym / sponsor ID: ALA-AK-CT003
Conditions: Actinic Keratosis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 122 participants (actual)
Lead sponsor: Biofrontera Bioscience GmbHIndustry (pharma, biotech, devices)
Study start: Dec 2007
Primary completion: Oct 2008 (actual)
Study completion: Oct 2008 (actual)
First posted: 14 Jun 2016 (estimated)
Results: Posted 6 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The aim of the study was to evaluate the efficacy and safety of BF-200 ALA (Ameluz) used with photodynamic therapy (PDT) in patients suffering from actinic keratosis.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Vehicle	Placebo comparator	Drug: VehicleTopical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.
BF-200 ALA	Active comparator	Drug: BF-200 ALATopical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (19 listed)

Subjects were willing and able to sign informed consent form.
Men and women aged between 18 and 85 years inclusive.
Subjects had a general good and stable health condition as confirmed by a physical examination and by medical history.
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 7, 10, 11 and 12 of the exclusion criteria:
Subjects accepted to abstain from sunbathing and the solarium during the study.

Key exclusion criteria (34 listed)

Had known hypersensitivity to 5-aminolevulinic acid (ALA).
Were subjects under immunosuppressive therapy.
Suffered from porphyria.
Showed hypersensitivity to porphyrins.
Suffered from photodermatoses.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Vehicletopical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation).	Drug	Vehicle
BF-200 ALAAlso: Ameluztopical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation).	Drug	BF-200 ALA

Primary outcome

Total Patient Clearance Rate 12 Weeks After the Last Photodynamic Therapy (PDT)
Time frame: 12 weeks after the last photodynamic therapy (PDT), up to 24 weeks
AK clearance rate, defined as the percentage of subjects with complete remission of all AK lesions in the target area(s) assessed 12 weeks after the last PDT (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment).
Total Patient Clearance Rate 12 Weeks After the Last Photodynamic Therapy (PDT)
Time frame: 12 weeks after the last PDT, up to 24 weeks
AK clearance rate, defined as the percentage of subjects with complete remission of all AK lesions in the target area(s) assessed 12 weeks after the last PDT (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment).
Total Patient Clearance Rate Treated With Narrow Spectrum Lamp 12 Weeks After the Last Photodynamic Therapy (PDT)
Time frame: 12 weeks after the last PDT, up to 24 weeks
AK clearance rate, defined as the percentage of subjects with complete remission of all AK lesions in the target area(s) assessed 12 weeks after the last PDT (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment). Analysis was for the subgroup: treated by narrow spectrum lamps only [n=15 (vehicle), n= 31 (BF-200 ALA)]
Total Patient Clearance Rate Treated With Narrow Spectrum Lamp 12 Weeks After the Last Photodynamic Therapy (PDT)
Time frame: 12 weeks after the last PDT, up to 24 weeks
AK clearance rate, defined as the percentage of subjects with complete remission of all AK lesions in the target area(s) assessed 12 weeks after the last PDT (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment). Analysis was for the subgroup: treated by narrow spectrum lamps only [n=13 (vehicle), n= 28 (BF-200 ALA)]

11 secondary outcomes

Percentage of AK Lesions Showing Complete Remission 12 Weeks After the Last PDT
Time frame: 12 weeks after the last PDT, up to 24 weeks
Percentage of AK Lesions Showing Complete Remission Treated With Narrow Spectrum Lamp 12 Weeks After the Last PDT
Time frame: 12 weeks after the last PDT, up to 24 weeks
Change in Total Lesion Size 12 Weeks After the Last PDT
Time frame: 12 weeks after the last PDT, up to 24 weeks
Change in Total Lesion Area 12 Weeks After the Last PDT (Treated Area Face)
Time frame: 12 weeks after the last PDT, up to 24 weeks
Change in Total Lesion Area 12 Weeks After the Last PDT (Treated Area Scalp)
Time frame: 12 weeks after the last PDT, up to 24 weeks
Subjects With Complete Clearance 12 Weeks After the First PDT
Time frame: 12 weeks after the first PDT
Subjects With Partial Clearance 12 Weeks After the Last PDT
Time frame: 12 weeks after the last PDT, up to 24 weeks
Overall Cosmetic Outcome 12 Weeks After the Last PDT
Time frame: 12 weeks after the last PDT, up to 24 weeks
Local Skin Reactions
Time frame: during and after PDT [3h - 4 h]
Discomfort During and After PDT
Time frame: during and after PDT [3h - 4 h]
Related Adverse Events /AEs)
Time frame: up to 24 weeks after the 1st PDT

Results and safety

Results posted to the registry on 6 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vehicle	41	37
BF-200 ALA	81	77

Primary outcome: Total Patient Clearance Rate 12 Weeks After the Last Photodynamic Therapy (PDT)

Time frame: 12 weeks after the last photodynamic therapy (PDT), up to 24 weeks. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Vehicle n = 40	BF-200 ALA n = 80
Value	12.5 (4.2 to 26.8)	66.3 (54.8 to 76.4)

Vehicle vs BF-200 ALA: p <0.0001, Cochran-Mantel-Haenszel

Population analysed: Full analysis set (FAS), Overall

Primary outcome: Total Patient Clearance Rate 12 Weeks After the Last Photodynamic Therapy (PDT)

Time frame: 12 weeks after the last PDT, up to 24 weeks. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Vehicle n = 37	BF-200 ALA n = 77
Value	10.8 (3.0 to 25.4)	63.6 (51.9 to 74.3)

Vehicle vs BF-200 ALA: p <0.0001, Cochran-Mantel-Haenszel

Population analysed: per protocol population (PPP), (Overall)

Primary outcome: Total Patient Clearance Rate Treated With Narrow Spectrum Lamp 12 Weeks After the Last Photodynamic Therapy (PDT)

Time frame: 12 weeks after the last PDT, up to 24 weeks. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Vehicle n = 15	BF-200 ALA n = 31
Value	13.3 (1.7 to 40.5)	87.1 (70.2 to 96.4)

Population analysed: FAS; subgroup analysis for patients only treated with narrow spectrum lamps

Primary outcome: Total Patient Clearance Rate Treated With Narrow Spectrum Lamp 12 Weeks After the Last Photodynamic Therapy (PDT)

Time frame: 12 weeks after the last PDT, up to 24 weeks. Number (95% Confidence Interval). Unit: percentage of patients

Measure	Vehicle n = 13	BF-200 ALA n = 28
Value	15.4 (1.9 to 45.4)	96.4 (81.7 to 99.9)

Population analysed: PPP; subgroup analysis for patients only treated with narrow spectrum lamps

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to 12 weeks after last treatment (PDT), i.e. 12 weeks after the first PDT or 12 weeks after the second PDT in case of retreatment. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vehicle	2 of 41 (4.9%)	20 of 41 (48.8%)	Not reported
BF-200 ALA	0 of 81 (0%)	78 of 81 (96.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 20518784Szeimies RM, Radny P, Sebastian M, Borrosch F, Dirschka T, Krahn-Senftleben G, Reich K, Pabst G, Voss D, Foguet M, Gahlmann R, Lubbert H, Reinhold U. Photodynamic therapy with BF-200 ALA for the treatment of actinic keratosis: results of a prospective, randomized, double-blind, placebo-controlled phase III study. Br J Dermatol. 2010 Aug;163(2):386-94. doi: 10.1111/j.1365-2133.2010.09873.x. Epub 2010 May 28.
Results publication: PubMed 23252768Dirschka T, Radny P, Dominicus R, Mensing H, Bruning H, Jenne L, Karl L, Sebastian M, Oster-Schmidt C, Klovekorn W, Reinhold U, Tanner M, Grone D, Deichmann M, Simon M, Hubinger F, Hofbauer G, Krahn-Senftleben G, Borrosch F, Reich K, Berking C, Wolf P, Lehmann P, Moers-Carpi M, Honigsmann H, Wernicke-Panten K, Hahn S, Pabst G, Voss D, Foguet M, Schmitz B, Lubbert H, Szeimies RM; AK-CT002 Study Group; AK-CT003 Study Group. Long-term (6 and 12 months) follow-up of two prospective, randomized, controlled phase III trials of photodynamic therapy with BF-200 ALA and methyl aminolaevulinate for the treatment of actinic keratosis. Br J Dermatol. 2013 Apr;168(4):825-36. doi: 10.1111/bjd.12158.
Individual participant dataSharing planned: No

Related trials for Actinic Keratosis

Active, not recruitingPhase 1
A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BCX17725
Netherton Syndrome
RecruitingPhase 3
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Upper Extremities
Actinic Keratosis
RecruitingPhase 3
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp
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Active, not recruitingPhase 3
A Pilot Clinical Trial Comparing Topical Fluorouracil to Fluorouracil Plus Calcipotriene Field Treatments in Patients With Multiple Actinic Keratoses
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RecruitingPhase 3
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rolf-Markus Szeimies, Prof Dr principal investigator

Klinikum der Universität Regensburg Klinik und Poliklinik für Dermatologie

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BF-200 ALA 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 19 inclusion and 34 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 6 Apr 2017. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Patient Clearance Rate 12 Weeks After the Last Photodynamic Therapy (PDT) (time frame: 12 weeks after the last photodynamic therapy (PDT), up to 24 weeks). The study lists 4 primary outcomes in all. 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 NCT02799082, which also lists 2 linked publications.

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 6 Apr 2017.