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Undersøgelse til evaluering af sikkerheden, tolerabiliteten og effektiviteten af ​​BF-200 ALA (Ameluz®) i feltrettet behandling af aktinisk keratose (AK) på ekstremiteter og nakke/stamme med fotodynamisk terapi (PDT) ved hjælp af en RhodoLED-lampe

30. juli 2026 opdateret af: Biofrontera Inc.

Et randomiseret, dobbeltblindt, køretøjsstyret, multicenter fase III-studie til evaluering af sikkerheden, tolerabiliteten og effektiviteten af ​​BF-200 ALA (Ameluz®) i den feltrettet behandling af aktinisk keratose på ekstremiteter og nakke/stamme med Fotodynamisk terapi (PDT) ved hjælp af BF-RhodoLED® XL- eller BF-RhodoLED®-lampen

Formålet med denne undersøgelse er at teste sikkerheden. tolerabilitet og effektivitet af feltstyret fotodynamisk terapi (PDT) med 10 % aminolevulinsyregel (Ameluz®, BF-200 ALA) i kombination med en af ​​de smalspektrede røde lys RhodoLED-lamper sammenlignet med vehikelbehandling for aktinisk keratose (AK) på ekstremiteter og nakke/stamme.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

172

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85032
        • Alliance Dermatology & Mohs Center
      • Phoenix, Arizona, Forenede Stater, 85006
        • Medical Dermatology Specialists
    • Colorado
      • Greenwood Village, Colorado, Forenede Stater, 80111
        • Dermatology Practice
    • Florida
      • Delray Beach, Florida, Forenede Stater, 33445
        • Dermatology Associates PA of the Palm Beaches
    • Georgia
      • Snellville, Georgia, Forenede Stater, 30078
        • Gwinnett Clinical Research Center, Inc.
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46260
        • Laser and Skin Surgery Center of Indiana
      • Plainfield, Indiana, Forenede Stater, 46168
        • The Indiana Clinical Trials Center, PC
    • Louisiana
      • Baton Rouge, Louisiana, Forenede Stater, 70809
        • DelRicht Research
    • New York
      • Rochester, New York, Forenede Stater, 14623
        • Skin Search Of Rochester, Inc.
      • Victor, New York, Forenede Stater, 14564
        • Rochester Dermatologic Surgery
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29407
        • Clinical Research Center of the Carolinas
    • Texas
      • Austin, Texas, Forenede Stater, 78759
        • DermResearch, P.A.
      • Houston, Texas, Forenede Stater, 77056
        • Austin Institute for Clinical Research
      • Pflugerville, Texas, Forenede Stater, 78660
        • Austin Institute for Clinical Research Inc.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  1. Forsøgspersoners vilje og evne til at give informeret samtykke og underskrive Health Insurance Portability and Accountability Act (HIPAA)-formularen. Et undersøgelsesspecifikt informeret samtykke og HIPAA-formular skal indhentes skriftligt, før der påbegyndes undersøgelsesprocedurer.
  2. 4 - 15 milde til moderate klinisk bekræftede AK-læsioner ifølge Olsen enten på ekstremiteterne eller på halsen/stammen med en diameter på ≥ 4 mm, der skal være til stede i behandlingsfeltet (defineret som AK-mållæsioner). Derudover kan ikke-mål AK-læsioner være til stede i behandlingsfeltet, herunder op til to alvorlige AK-læsioner ≥ 4 mm. For hver alvorlig AK-læsion (≥ 4 mm) skal der tages en biopsi til bekræftelse af diagnosen. Behandlingsfeltet (kontinuerligt eller i flere plastre) på i alt ca. enten 80 cm², 160 cm² eller 240 cm2 skal være inden for et effektivt belysningsområde af BF-RhodoLED® XL, men kan kræve op til tre belysninger med BF-RhodoLED®. Alle AK-mållæsioner og, hvis det er relevant, alvorlige AK-læsioner ≥ 4 mm placeret i behandlingsfeltet skal være tydeligt skelnelige uden begrænsninger i afstanden mellem læsionerne og bør have en minimal afstand på 1 cm til grænsen af ​​behandlingsfeltet.
  3. Alle køn, ≥ 18 år.
  4. Villighed til at gennemgå en 2 mm punch-biopsi for hver (op til to) alvorlige AK-læsioner ≥ 4 mm, hvis det er relevant, ved screeningsbesøget.
  5. Vilje og evne til at overholde undersøgelsesprocedurer, især villighed til at modtage op til 2 PDT'er inden for cirka 12 uger.
  6. Forsøgspersoner med et godt generelt helbred eller med klinisk stabile medicinske tilstande vil få tilladelse til at blive inkluderet i undersøgelsen.
  7. Villighed til at stoppe brugen af ​​fugtighedscreme og enhver anden ikke-medicinsk topisk behandling inden for behandlingsområdet mindst 24 timer før næste kliniske besøg.
  8. Accept af at afholde sig fra omfattende solbadning og brug af solarium eller solarier i behandlingsfasen.
  9. Til kvindelige forsøgspersoner med reproduktionspotentiale: Negativ serumgraviditetstest.
  10. Til kvindelige forsøgspersoner med reproduktionspotentiale: Effektiv prævention ved screeningsbesøg og gennem hele undersøgelsens behandlingsfase (indtil besøg 4 eller besøg 6).

Ekskluderingskriterier:

  1. Enhver kendt historie med overfølsomhed over for ALA, porphyriner eller hjælpestoffer af BF-200 ALA.
  2. Historie om soja- eller jordnøddeallergi.
  3. Solskoldning eller andre mulige forvirrende hudtilstande (f.eks. sår, irritationer, blødninger eller hudinfektioner) inde i eller i umiddelbar nærhed (< 2 cm afstand) til behandlingsfeltet.

  4. Klinisk signifikante (cs) medicinske tilstande, der gør implementering af protokollen eller fortolkning af undersøgelsesresultaterne vanskelig eller forringer forsøgspersonens sikkerhed, såsom:

    1. Tilstedeværelse af fotodermatoser eller porfyri
    2. Metastatisk tumor eller tumor med høj sandsynlighed for metastase
    3. Infiltrerende hudneoplasi (mistænkt eller kendt)
    4. Ustabil hjerte-kar-sygdom (New York Heart Association klasse III, IV)
    5. Ustabil hæmatologisk (herunder myelodysplastisk syndrom), lever-, nyre-, neurologisk eller endokrin tilstand
    6. Ustabil kollagen-vaskulær tilstand
    7. Ustabil mave-tarmtilstand
    8. Immunsuppressiv tilstand
    9. Tilstedeværelse af klinisk signifikant arvelig eller erhvervet koagulationsdefekt
  5. Klinisk diagnosticering af atopisk dermatitis, Bowens sygdom (BD), basalcellekarcinom (BCC), eksem, psoriasis, rosacea, planocellulært karcinom (SCC), andre ondartede eller godartede tumorer inde i eller i umiddelbar nærhed (< 2 cm afstand) til behandlingsområdet.
  6. Tilstedeværelse af stærk kunstig pigmentering (f.eks. tatoveringer) eller enhver anden abnormitet, der kan påvirke læsionsvurdering eller lysgennemtrængning i behandlingsområdet.
  7. Enhver fysioterapi såsom kryoterapi, laserterapi, elektrodessication, mikrodermabrasion, kirurgisk fjernelse af læsioner, curettage eller behandling med kemisk peeling såsom trichloreddikesyre inde i eller i umiddelbar nærhed (< 10 cm afstand) til behandlingsfeltet inden for 4 uger før screening.

  8. Enhver af de topiske behandlinger defineret nedenfor inden for de angivne perioder før screening:

    1. Topisk behandling med ALA- eller ALA-estere (f.eks. methylaminolevulinsyre (MAL)) inden for behandlingsområdet inden for 3 måneder.
    2. Topisk behandling med immunmodulerende, cytostatiske eller cytotoksiske lægemidler inde i eller i umiddelbar nærhed (< 10 cm afstand) til behandlingsfeltet inden for 3 måneder.
    3. Start af topisk administration af en medicin med hypericin eller andre lægemidler med fototoksisk eller fotoallergisk potentiale inden for eller i umiddelbar nærhed (< 10 cm afstand) til behandlingsfeltet inden for 4 uger. Forsøgspersoner kan dog være berettigede, hvis sådan medicin blev anvendt i mere end 4 uger før screening uden tegn på en egentlig fototoksisk/fotoallergisk reaktion.

  9. Enhver brug af de systemiske behandlinger inden for de angivne perioder før screening:

    1. Cytostatika eller cellegift inden for 6 måneder.
    2. Immunsuppressive terapier eller ALA- eller ALA-estere (f.eks. MAL) inden for 12 uger.
    3. Lægemidler, der vides at have større organtoksicitet inden for 8 uger.
    4. Interferon eller glukokortikosteroider inden for 6 uger.
    5. Start af indtagelse af medicin med hypericin eller lægemidler med fototoksisk eller fotoallergisk potentiale inden for 8 uger før screening. Forsøgspersoner kan dog være berettigede, hvis sådan medicin blev indtaget i mere end 8 uger før screeningsbesøget uden tegn på en egentlig fototoksisk/fotoallergisk reaktion.
  10. Ammende kvinder.
  11. Mistanke om stof- eller alkoholmisbrug.
  12. Forsøgspersoner, der sandsynligvis ikke vil overholde protokollen, f.eks. manglende evne til at vende tilbage til besøg, usandsynligt at gennemføre undersøgelsen eller upassende efter investigators mening.
  13. Et medlem af studiestedets personale eller sponsorpersonale, der er direkte involveret i udførelsen af ​​protokollen eller en nær slægtning hertil.
  14. Modtagelse af ethvert forsøgslægemiddel eller medicinsk produkt inden for 8 uger før screening eller samtidig deltagelse i et andet klinisk studie.

Revurdering af emner er tilladt én gang, hvis udelukkelseskriterium 3 er opfyldt, og berettigelse kan opnås inden for 4 uger. Revurdering kan ske på dagen for selve behandlingen.

Udelukkelseskriterier for doseringsdag:

Ved besøg 2 (baseline, PDT-1)

Personer med solskoldning eller andre muligvis forvirrende hudtilstande (f.eks. sår, irritationer, blødninger eller hudinfektioner) inde i eller i umiddelbar nærhed (< 2 cm afstand) til behandlingsfeltet. Revurdering af forsøgspersoner er tilladt én gang, hvis solskoldningen eller andre forstyrrende hudtilstande forventes at forsvinde inden for 2 uger.

Ved besøg 4 (PDT-2)

Personer med solskoldning eller andre muligvis forvirrende hudtilstande (f.eks. sår, irritationer, blødninger eller hudinfektioner) inde i eller i umiddelbar nærhed (< 2 cm afstand) til behandlingsfeltet. Omlægning af PDT-2 kan tidligst udføres én gang efter opløsning, men omlægning bør ikke overstige 2 uger.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Køretøj
Topisk påføring af vehikel til BF-200 ALA uden aktiv ingrediens. Rødt lys fotodynamisk terapi (PDT)
Kombinationsprodukt: Køretøj og rødt lys LED-lampe

Op til to PDT'er ved hjælp af en RhodoLED-lampe (RhodoLED® XL eller BF-RhodoLED®) (Vehicle-PDT):

Topisk påføring af vehikel med op til 3 rør på det udvidede behandlingsfelt (op til 240 cm²), efterfulgt af rødt lys med en RhodoLED-lampe efter 3 timers inkubation af undersøgelsesmedicin under okklusiv forbinding.

PDT-1 vil blive udført ved besøg 2. Klinisk clearance vil blive vurderet 12 uger efter PDT-1 (besøg 4). I tilfælde af resterende læsioner ved besøg 4, vil PDT-2 blive udført ved samme besøg.
Eksperimentel: BF-200 ALA

Topical application of BF-200 ALA containing 10% 5-ALA HCl (5-aminolevulinic acid hydrochloride).

Red light photodynamic therapy (PDT)
Kombinationsprodukt: BF-200 ALA og rødt lys LED-lampe

Op til to PDT'er ved hjælp af en RhodoLED-lampe (RhodoLED® XL eller BF-RhodoLED®) (ALA-PDT, Ameluz®-PDT):

Topisk påføring af op til 3 rør BF-200 ALA på det udvidede behandlingsfelt (op til 240 cm²), efterfulgt af rødt lys med en RhodoLED-lampe efter 3 timers inkubation af undersøgelsesmedicin under okklusiv forbinding.

PDT-1 vil blive udført ved besøg 2. Klinisk clearance vil blive vurderet 12 uger efter PDT-1 (besøg 4). I tilfælde af resterende læsioner ved besøg 4, vil PDT-2 blive udført ved samme besøg.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Subject Complete Response Rate
Tidsramme: 12 weeks after the last PDT (Visit 4 or Visit 6)
Percentage of subjects with all AK target lesions clinically cleared after last PDT
12 weeks after the last PDT (Visit 4 or Visit 6)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Subject Complete Response Rate for Subjects With Lesions Treated on Extremities
Tidsramme: 12 weeks after the last PDT (Visit 4 or Visit 6)
Percentage of subjects with all AK target lesions on extremities clinically cleared after last PDT
12 weeks after the last PDT (Visit 4 or Visit 6)
Overall Subject Complete Response Rate for Subjects With Lesions Treated on Neck/Trunk
Tidsramme: 12 weeks after the last PDT (Visit 4 or Visit 6)
Percentage of subjects with all AK target lesions on neck/trunk clinically cleared after last PDT
12 weeks after the last PDT (Visit 4 or Visit 6)
Lesion Complete Response Rate
Tidsramme: 12 weeks after the last PDT (Visit 4 or Visit 6)
Percentage of clinically cleared individual AK target lesions in relation to total number of AK target lesions at baseline (Visit 2) after the last PDT, overall and stratified by treatment area and AK severity at baseline (according to Olsen).
12 weeks after the last PDT (Visit 4 or Visit 6)
Complete Response Rate for Severe Lesions
Tidsramme: 12 weeks after the last PDT (Visit 4 or Visit 6)
Percentage of clinically cleared individual severe AK lesions in relation to total number of severe AK lesions at baseline (according to Olsen; Visit 2) after the last PDT, overall and stratified by treatment area.
12 weeks after the last PDT (Visit 4 or Visit 6)
Subject Complete Response Rate After PDT-1
Tidsramme: 12 weeks after PDT-1 (Visit 4)
Percentage of subjects with all AK target lesions clinically cleared after PDT-1, overall and stratified by AK baseline parameters.
12 weeks after PDT-1 (Visit 4)
Lesion Complete Response Rate After PDT-1
Tidsramme: 12 weeks after PDT-1 (Visit 4)
Percentage of clinically cleared individual AK target lesions in relation to total number of AK target lesions at baseline (Visit 2) after PDT-1, overall and stratified by treatment area and AK severity at baseline (according to Olsen [mild, moderate, severe]).
12 weeks after PDT-1 (Visit 4)
Complete Response Rate for Severe Lesions After PDT-1
Tidsramme: 12 weeks after PDT-1 (Visit 4)
Percentage of clinically cleared individual severe AK lesions in relation to total number of severe AK lesions at baseline (according to Olsen [mild, moderate, severe]; Visit 2) after PDT-1, overall and stratified by treatment area.
12 weeks after PDT-1 (Visit 4)
Esthetic Appearance at the End of Treatment Phase Assessed by the Investigator
Tidsramme: On final visit of the treatment phase, 12 weeks after the last PDT (Visit 4 or Visit 6)
The esthetic appearance after the last PDT as assessed by the investigator according to a 4-point scale ranging from 0 (=very good) to 3 (=unsatisfactory); overall and stratified by treatment area.
On final visit of the treatment phase, 12 weeks after the last PDT (Visit 4 or Visit 6)
Esthetic Outcome at the End of Treatment Phase Assessed by the Subject
Tidsramme: On final visit of the treatment phase, 12 weeks after the last PDT (Visit 4 or Visit 6)
The esthetic outcome after the last PDT as assessed by the subject according to a 4-point scale ranging from 0 (=very good) to 3 (=unsatisfactory); overall and stratified by treatment area.
On final visit of the treatment phase, 12 weeks after the last PDT (Visit 4 or Visit 6)
Satisfaction With PDT at the End of Treatment Phase
Tidsramme: On final visit of the treatment phase, 12 weeks after the last PDT (Visit 4 or Visit 6)
Satisfaction with PDT treatment after the last PDT as assessed by the subject; overall and stratified by treatment area. Therefore, subjects were asked if they would chose PDT treatment in the future in case of recurrence or similar disease (yes/no).
On final visit of the treatment phase, 12 weeks after the last PDT (Visit 4 or Visit 6)
Frequency and Extent of Adverse Events (AEs), AEs of Special Interest (AESIs), Serious AEs (SAEs) and Treatment-emergent AEs (TEAEs) During Treatment Phase
Tidsramme: During entire treatment phase, approx. 16 weeks for subjects requiring 1 PDT (until Visit 4) and approx. 28 weeks for subjects with 2 PDTs (until Visit 6)

Frequency and extent of AEs, AESIs, SAEs, and TEAEs, overall and stratified by demographics, skin type class (I-III and IV-VI), size of the treatment field, and treatment area.

TEAEs were defined as all AEs starting with or after IMP application and within 12 weeks (+ 7 days) after the last PDT, or as related AEs (possibly, probably, or definitely related, or with missing relationship) occurring more than 12 weeks after the last PDT.
During entire treatment phase, approx. 16 weeks for subjects requiring 1 PDT (until Visit 4) and approx. 28 weeks for subjects with 2 PDTs (until Visit 6)
New Lesions Inside the Treatment Field During Treatment Phase
Tidsramme: All clinical visits throughout the treatment phase, approx. 16 weeks for subjects requiring 1 PDT (until Visit 4) and approx. 28 weeks for subjects with 2 PDTs (until Visit 6)
New lesions: AK, non-melanoma skin cancer [NMSC, including Basal Cell Carcinoma (BCC), Squamous Cell Carcinoma (SCC) or Bowen's Disease (BD)] or melanoma
All clinical visits throughout the treatment phase, approx. 16 weeks for subjects requiring 1 PDT (until Visit 4) and approx. 28 weeks for subjects with 2 PDTs (until Visit 6)
Assessment of Application Site Reactions
Tidsramme: All visits (except screening, Visit 1) throughout the treatment phase, approx. 16 weeks for subjects requiring 1 PDT (until Visit 4) and approx. 28 weeks for subjects with 2 PDTs (until Visit 6)
Application site reactions (bleeding, burning, discharge, edema, erosion, erythema, exfoliation, hyperalgesia, induration, irritation, paraesthesia, pruritus, pustules, scabbing, or vesicles) were assessed on a 4-point scale: grade 0 = none, grade 1 = mild, grade 2 = moderate, grade 3 = severe. The worst severity across all assessment timepoints and illumination areas is presented.
All visits (except screening, Visit 1) throughout the treatment phase, approx. 16 weeks for subjects requiring 1 PDT (until Visit 4) and approx. 28 weeks for subjects with 2 PDTs (until Visit 6)
Application Site Pain During Illumination
Tidsramme: During treatment (illumination) on treatment day for PDT-1 (Visit 2, up to 4 weeks after screening) and during treatment (illumination) on treatment day for PDT-2 (Visit 4; if applicable; 12 weeks after PDT-1)
Reported by the subjects assessed on an 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst imaginable pain); overall and stratified by size of the treatment field and treatment area. The maximum of pain score over all illuminations is shown.
During treatment (illumination) on treatment day for PDT-1 (Visit 2, up to 4 weeks after screening) and during treatment (illumination) on treatment day for PDT-2 (Visit 4; if applicable; 12 weeks after PDT-1)
Number of Patients With Significant Changes of Vital Signs
Tidsramme: All clinical visits throughout the treatment phase, approx. 16 weeks for subjects requiring 1 PDT (until Visit 4) and approx. 28 weeks for subjects with 2 PDTs (until Visit 6)
Number of patients with changes in blood pressure (systolic and diastolic) [mmHg] and changes in pulse rate [beats/min]. Findings which differed from reference range and were considered clinically significant were to be reported.
All clinical visits throughout the treatment phase, approx. 16 weeks for subjects requiring 1 PDT (until Visit 4) and approx. 28 weeks for subjects with 2 PDTs (until Visit 6)
Number of Patients With Significant Changes in Safety Laboratory
Tidsramme: All clinical visits throughout the treatment phase, approx. 16 weeks for subjects requiring 1 PDT (until Visit 4) and approx. 28 weeks for subjects with 2 PDTs (until Visit 6)
Changes in clinical chemistry, in hematology and urinalysis parameters as defined in the protocol. Findings which differed from reference range and were considered clinically significant were to be reported.
All clinical visits throughout the treatment phase, approx. 16 weeks for subjects requiring 1 PDT (until Visit 4) and approx. 28 weeks for subjects with 2 PDTs (until Visit 6)
Number of Patients With Abnormal Findings in Physical Examination
Tidsramme: At screening (up to 4 weeks before treatment) and 12 weeks after the last PDT (Visit 4 or Visit 6)
Physical examination of head, neck, skin, lymph nodes, thorax including heart and lungs, abdomen, and musculoskeletal, peripheral vascular and nervous system status were to be performed. Abnormal findings considered clinically significant were to be reported.
At screening (up to 4 weeks before treatment) and 12 weeks after the last PDT (Visit 4 or Visit 6)

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Subject Recurrence Rate
Tidsramme: On follow-up Visit 1 (6 months after last PDT) and follow-up Visit 2 (12 months after last PDT)
The percentage of subjects with all AK target lesions clinically cleared 12 weeks after the last PDT presenting with at least one recurrent lesion during follow-up, stratified by demographics, study sites, AK baseline parameters
On follow-up Visit 1 (6 months after last PDT) and follow-up Visit 2 (12 months after last PDT)
Lesion Recurrence Rate
Tidsramme: On follow-up Visit 1 (6 months after last PDT) and follow-up Visit 2 (12 months after last PDT)
The percentage of AK target lesions showing recurrence in follow-up in relation to total number of clinically cleared AK target lesions 12 weeks after last PDT; overall and stratified by treatment area and AK severity at baseline (according to Olsen [mild, moderate, severe])
On follow-up Visit 1 (6 months after last PDT) and follow-up Visit 2 (12 months after last PDT)
Recurrence Rate of Severe Lesions
Tidsramme: On follow-up Visit 1 (6 months after last PDT) and follow-up Visit 2 (12 months after last PDT)
The percentage of severe AK lesions (according to Olsen [mild, moderate, severe]) showing recurrence in follow-up in relation to total number of clinically cleared severe AK lesions 12 weeks after last PDT; overall and stratified by treatment area
On follow-up Visit 1 (6 months after last PDT) and follow-up Visit 2 (12 months after last PDT)
Esthetic Appearance at Follow-up Visits Assessed by the Investigator
Tidsramme: On follow-up Visit 1 (6 months after last PDT) and follow-up Visit 2 (12 months after last PDT)
The esthetic outcome at follow-up visits as assessed by the subject according to a 4-point scale ranging from 0 (=very good) to 3 (=unsatisfactory); overall and stratified by treatment area
On follow-up Visit 1 (6 months after last PDT) and follow-up Visit 2 (12 months after last PDT)
Esthetic Outcome at Follow-up Visits Assessed by the Subject
Tidsramme: On follow-up Visit 1 (6 months after last PDT) and follow-up Visit 2 (12 months after last PDT)
The esthetic outcome at follow-up visits as assessed by the subject according to a 4-point scale ranging from 0 (=very good) to 3 (=unsatisfactory); overall and stratified by treatment area
On follow-up Visit 1 (6 months after last PDT) and follow-up Visit 2 (12 months after last PDT)
Satisfaction With PDT at Follow-up Visits
Tidsramme: On follow-up Visit 1 (6 months after last PDT) and follow-up Visit 2 (12 months after last PDT)
Satisfaction with PDT treatment after the last PDT as assessed by the subject via questionnaire, 1. if they would chose PDT treatment in the future in case of recurrence or similar disease (yes/no) and 2. how they would rate the PDT treatment in comparison to other treatment modalities, if applicable (better than/ similar/ worse). The treatment modalities should be documented, if applicable); overall and stratified by treatment area
On follow-up Visit 1 (6 months after last PDT) and follow-up Visit 2 (12 months after last PDT)
Any SAE and Relevant AE
Tidsramme: Entire follow-up duration, approx. 40 weeks
Relevant AEs include AEs or conditions affecting skin health in the treatment field which may impair proper assessment of the recurrence rate of the treated AK lesions, or other clinically relevant events at the investigator's discretion as well as any SAE that has occurred since the final visit of the treatment phase (Visit 4 or Visit 6); overall and stratified by demographics and treatment area
Entire follow-up duration, approx. 40 weeks
New Lesions Inside the Treatment Field During Follow-up
Tidsramme: On follow-up Visit 1 (6 months after last PDT) and follow-up Visit 2 (12 months after last PDT)
New lesions: AK, non-melanoma skin cancer [NMSC, including BCC, SCC or BD] or melanoma
On follow-up Visit 1 (6 months after last PDT) and follow-up Visit 2 (12 months after last PDT)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Biofrontera Inc.

Efterforskere

  • Ledende efterforsker: Nathalie Zeitouni, MD, Medical Dermatology Specialists; Phoenix, Arizona, United States

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

12. december 2022

Primær færdiggørelse (Faktiske)

3. september 2025

Studieafslutning (Faktiske)

1. juli 2026

Datoer for studieregistrering

Først indsendt

29. november 2022

Først indsendt, der opfyldte QC-kriterier

20. december 2022

Først opslået (Faktiske)

22. december 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ALA-AK-CT019

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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