Clinical trial • Phase IV • Dermatology

TIRBANIBULIN for Actinic keratosis

Phase IV trial of TIRBANIBULIN for Actinic keratosis.

Overview

Trial Therapeutic Area
Dermatology
Trial Disease
Actinic keratosis
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
14-06-2024
First CTIS Authorization Date
15-07-2024

Trial design

Randomised, active comparator: solaraze 30 mg/g gel (diclofenac sodium 3% gel), topical; product information indicates a maximum treatment period of 90 (time unit code 1) and maxtotaldoseamount 1080 (as recorded in product data).-controlled Phase IV trial across 44 sites in France, Germany, Spain and others.

Randomised
Yes
Comparator
Active comparator: Solaraze 30 mg/g Gel (diclofenac sodium 3% gel), topical; product information indicates a maximum treatment period of 90 (time unit code 1) and maxTotalDoseAmount 1080 (as recorded in product data).
Target Sample Size
418
Trial Duration For Participant
1095

Eligibility

Recruits 418 Vulnerable population not selected. Participants must provide written informed consent in accordance with institutional and regulatory guidelines. No minors (only ≥18 years) and no vulnerable groups specified..

Pregnancy Exclusion
Females who are pregnant or nursing or who are intending to become pregnant
Vulnerable Population
Vulnerable population not selected. Participants must provide written informed consent in accordance with institutional and regulatory guidelines. No minors (only ≥18 years) and no vulnerable groups specified.

Inclusion criteria

  • {"criterion_text":"- Male or female and ≥18 years old"}
  • {"criterion_text":"- A TF on the face or scalp (excluding lips, eyelids, ears, and inside the nostrils), that: • Is a contiguous area measuring 25 cm2, • Contains 2 to 8 clinically typical, visible, and discrete AK lesions, and • Has an overall clinical picture that is consistent with Olsen grade 1 (see Appendix 3 of the protocol)"}
  • {"criterion_text":"- If a WOCBP, ie, fertile, defined as a female in the life period from menarche and until becoming post-menopausal (no menses for 12 months without an alternative medical cause) or permanently sterile (with hysterectomy, bilateral salpingectomy or bilateral oophorectomy at least 3 months prior to Screening), she must: • Have a negative urine pregnancy test using a highly sensitive method at screening and on Day 1 prior to treatment administration. • Be using effective methods of birth control. • Agree to have pregnancy tests while in the study and at the end of the study (according to the Schedule of Assessments in Table 1 of the protocol)"}
  • {"criterion_text":"- Patients should be willing to avoid sunlight or UV light exposure, including the use of tanning beds, to the face or scalp during the study"}
  • {"criterion_text":"- Patients should have the ability to understand the purpose and risks of the study, willingness and ability to comply with the protocol, and provide written informed consent in accordance with institutional and regulatory guidelines"}

Exclusion criteria

  • {"criterion_text":"- The location of the TF is: a) On any location other than the face or scalp. b) Within 5 cm of an incompletely healed wound. c) Within 10 cm of a suspected basal cell carcinoma (BCC) or other neoplasm. d) On the lips, eyelids, ears, or inside the nostrils, periorbital, perioral, or the skin surrounding the nostrils."}
  • {"criterion_text":"- Use of the following therapies and/or medications within 4 weeks prior to the Screening Visit: a) Treatment with cytotoxic drugs (eg, cyclophosphamide, vinblastine, chlorambucil, methotrexate) b) Treatment with systemic medications that modulate and/or suppress the immune system (eg, cyclosporine, prednisone, methotrexate, alefacept, infliximab, interferons or interferon inducers) c) Use of systemic retinoids (eg, isotretinoin, acitretin, bexarotene)"}
  • {"criterion_text":"- Use of the following therapies and/or medications within 2 weeks prior to the Screening Visit: a) Cosmetic or therapeutic procedures (eg, use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing) within the TF or within a 2 cm margin of the selected TF. b) Acid-containing therapeutic products (eg, salicylic acid or fruit acids, such as alpha and beta-hydroxyl acids and glycolic acids), topical retinoids, or light chemical peels within the TF or within a 2 cm margin of the selected TF. c) Topical steroids within the TF or within a 2 cm margin of the selected TF. d) Artificial tanners within the TF or within a 5 cm margin of the selected TF"}
  • {"criterion_text":"- History of sensitivity and/or allergy to any of the ingredients in the study medications to tirbanibulin, diclofenac, or nonsteroidal anti-inflammatory drugs (ie, NSAIDs)."}
  • {"criterion_text":"- A skin disease (eg, atopic dermatitis, psoriasis, eczema) or condition (eg, scarring, open wounds) that, in the opinion of the Investigator, might interfere with the study conduct or evaluations, or which exposes the patient to unacceptable risk by study participation."}
  • {"criterion_text":"- Significant uncontrolled or unstable medical diseases or conditions that, in the opinion of the Investigator, would expose the patient to unacceptable risk by study participation"}
  • {"criterion_text":"- Females who are pregnant or nursing or who are intending to become pregnant"}
  • {"criterion_text":"- Participated in an investigational drug study during which an investigational study medication was administered within 30 days or 5 half-lives of the investigational product, whichever is longer, prior to screening"}
  • {"criterion_text":"- Patient who is an employee or a relative to an employee at the research site or Almirall"}
  • {"criterion_text":"- Presence in the TF of: a) Clinically atypical and/or rapidly changing AK lesions b) Hyperkeratotic or hypertrophic lesions, recalcitrant disease (had cryosurgery on 2 previous occasions), and/or cutaneous horn. c) Confluent AK lesions (ie, non-discrete lesions, as per inclusion criterion 2). d) Persisting AK lesions at the screening visit following topical treatment with diclofenac sodium 3% gel."}
  • {"criterion_text":"- History of any malignant skin tumour in the TF or history of skin tumour in any region of the body which has metastasized or in which metastasis within the study period is likely."}
  • {"criterion_text":"- History of any malignant tumour with systemic antitumor treatment (including radiotherapy) within 12 weeks prior to the Screening Visit or systemic antitumor treatment is expected while on the study."}
  • {"criterion_text":"- Immunocompromised patients, including patients with a history of chronic systemic lymphoma or chronic myeloid leukaemia, or organ transplant recipients."}
  • {"criterion_text":"- Any other dermatological disease that causes difficulty with examination within the treatment area"}
  • {"criterion_text":"- Anticipated need for inpatient hospitalization or inpatient surgery during the study."}
  • {"criterion_text":"- Previous treatment with tirbanibulin 10 mg/g ointment in the selected TF."}
  • {"criterion_text":"- Treatment with 5-fluorouracil, imiquimod, ingenol mebutate, diclofenac, photodynamic therapy, or other topical treatments for AK within the TF or within 2 cm of the TF, within 8 weeks prior to the Screening Visit."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Proportion of patients with histologically confirmed invasive SCC in the TF over the 3-year study period.","definition_or_measurement_approach":"Incidence of biopsy-confirmed invasive squamous cell carcinoma (SCC) occurring in the selected treatment field (TF) assessed over a 3-year study period; histological confirmation required."}

Secondary endpoints

  • {"endpoint_text":"- AEs and SAEs over 3 years","definition_or_measurement_approach":"Adverse events (AEs) and serious adverse events (SAEs) collected and reported over the 3-year follow-up period."}
  • {"endpoint_text":"- Proportion of patients with any other skin cancer (other than SCC) in the TF over the 3-year study period","definition_or_measurement_approach":"Proportion of patients developing skin cancers other than SCC in the TF during the 3-year study period."}
  • {"endpoint_text":"- Time to occurrence of invasive SCC from baseline in the TF.","definition_or_measurement_approach":"Time-to-event analysis measuring time from baseline to first occurrence of invasive SCC in the TF."}
  • {"endpoint_text":"- Proportion of patients requiring rescue treatment after 1 treatment course.","definition_or_measurement_approach":"Proportion of patients who require rescue therapy following one treatment course; assessed during study visits."}
  • {"endpoint_text":"- Proportion of patients requiring rescue treatment at any time during the study.","definition_or_measurement_approach":"Proportion of patients requiring rescue treatment at any time during the 3-year study."}
  • {"endpoint_text":"- Proportion of patients with no lesions after treatment of the first recurrence with tirbanibulin during the first 52 weeks.","definition_or_measurement_approach":"Proportion of patients who are lesion-free after treatment of first recurrence with tirbanibulin within the first 52 weeks."}
  • {"endpoint_text":"- Other safety assessments (vital signs, PE) over 3 years.","definition_or_measurement_approach":"Routine safety assessments including vital signs and physical examination (PE) collected over 3 years."}
  • {"endpoint_text":"- Change from baseline in Skindex-16 overall and for all three domain scores (Symptoms, Emotions, and Functioning) by arm and by visit.","definition_or_measurement_approach":"Change from baseline in Skindex-16 total and domain scores measured by treatment arm at each visit."}
  • {"endpoint_text":"- Cosmetic outcome by arm and by visit.","definition_or_measurement_approach":"Assessment of cosmetic outcome by treatment arm at scheduled visits."}
  • {"endpoint_text":"- Treatment Satisfaction Questionnaire for Medication transformed scores by arm and by visit.","definition_or_measurement_approach":"TSQM (Treatment Satisfaction Questionnaire for Medication) transformed scores evaluated by arm and visit."}

Recruitment

Planned Sample Size
418
Recruitment Window Months
57
Consent Approach
Written informed consent is required from participants; inclusion criteria specify participants must provide written informed consent in accordance with institutional and regulatory guidelines. A subject information and informed consent form is listed among the trial documents (e.g., L1_M-14789-41_ITA_Main_ICF_Adult_ita_FP) and a privacy notice document is provided. Only adults (≥18 years) are eligible; no assent procedures or paediatric consent forms are indicated.

Geography

Total Number Of Sites
44
Total Number Of Participants
418

France

Earliest CTIS Part Ii Submission Date
02-07-2024
Latest Decision Or Authorization Date
12-08-2024
Processing Time Days
41
Number Of Sites
6
Number Of Participants
116

Sites

Site Name
Centre Hospitalier Regional De Marseille
Department Name
Service de Dermatologie
Principal Investigator Name
Marie-Aleth Richard
Principal Investigator Email
mariealeth.richard@ap-hm.fr
Contact Person Name
Marie-Aleth Richard
Contact Person Email
mariealeth.richard@ap-hm.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service de Dermatologie Service de Dermatologie
Principal Investigator Name
Johan Chanal
Principal Investigator Email
johan.chanal@aphp.fr
Contact Person Name
Johan Chanal
Contact Person Email
johan.chanal@aphp.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Clinique de Dermatologie
Principal Investigator Name
Laurent Mortier
Principal Investigator Email
laurent.mortier@chru-lille.fr
Contact Person Name
Laurent Mortier
Contact Person Email
laurent.mortier@chru-lille.fr
Site Name
Centre Hospitalier Universitaire Rouen
Department Name
Clinique Dermatologique
Principal Investigator Name
Anne-Bénédicte DUVAL-MODESTE
Principal Investigator Email
anne-benedicte.duval-modeste@chu-rouen.fr
Contact Person Name
Anne-Bénédicte DUVAL-MODESTE
Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
Service de Dermatologie
Principal Investigator Name
Jean-Luc Perrot
Principal Investigator Email
j.luc.perrot@chu-st-etienne.fr
Contact Person Name
Jean-Luc Perrot
Contact Person Email
j.luc.perrot@chu-st-etienne.fr
Site Name
Tagast 41
Department Name
Liberal Cabinet TAGAST 41
Principal Investigator Name
Abdallah Khemis
Principal Investigator Email
abdallah.khemis@outlook.fr
Contact Person Name
Abdallah Khemis
Contact Person Email
abdallah.khemis@outlook.fr

Germany

Earliest CTIS Part Ii Submission Date
02-07-2024
Latest Decision Or Authorization Date
22-07-2024
Processing Time Days
20
Number Of Sites
13
Number Of Participants
51

Sites

Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Dermatologie
Principal Investigator Name
Markus Heppt
Principal Investigator Email
markus.heppt@uk-erlangen.de
Contact Person Name
Markus Heppt
Contact Person Email
markus.heppt@uk-erlangen.de
Site Name
Dermatologikum Hamburg GmbH
Department Name
Dermatologie
Principal Investigator Name
Peter Weisenseel
Principal Investigator Email
info@dermatologikum.de
Contact Person Name
Peter Weisenseel
Contact Person Email
info@dermatologikum.de
Site Name
Derma Science GmbH
Department Name
Dermatologie
Principal Investigator Name
Welf Prager
Principal Investigator Email
science@derma-hamburg.de
Contact Person Name
Welf Prager
Contact Person Email
science@derma-hamburg.de
Site Name
MVZ Dermatologisches Zentrum Bonn GmbH
Department Name
Dermatologie
Principal Investigator Name
Uwe Reinhold
Principal Investigator Email
u.reinhold@derma-bonn.de
Contact Person Name
Uwe Reinhold
Contact Person Email
u.reinhold@derma-bonn.de
Site Name
Klinikum Lippe GmbH
Department Name
Dermatologie
Principal Investigator Name
Helger Stege
Principal Investigator Email
Helger.Stege@klinikum-lippe.de
Contact Person Name
Helger Stege
Contact Person Email
Helger.Stege@klinikum-lippe.de
Site Name
Thermalsole und Schwefelbad Bentheim GmbH
Department Name
Dermatologie
Principal Investigator Name
Athanasios Tsianakas
Principal Investigator Email
a.tsianakas@fk-bentheim.de
Contact Person Name
Athanasios Tsianakas
Contact Person Email
a.tsianakas@fk-bentheim.de
Site Name
Hms GmbH
Department Name
Dermatologie
Principal Investigator Name
Sebastian Zimmer
Principal Investigator Email
science@hautmedizin-saar.de
Contact Person Name
Sebastian Zimmer
Contact Person Email
science@hautmedizin-saar.de
Site Name
Klinikum Vest GmbH
Department Name
Dermatologie
Principal Investigator Name
Rolf-Markus Szeimies
Principal Investigator Email
Rolf-Markus.Szeimies@klinikum-vest.de
Contact Person Name
Rolf-Markus Szeimies
Site Name
Universitaetsklinikum Augsburg
Department Name
Dermatologie
Principal Investigator Name
Julia Welzel
Principal Investigator Email
julia.welzel@uk-augsburg.de
Contact Person Name
Julia Welzel
Contact Person Email
julia.welzel@uk-augsburg.de
Site Name
Technische Universitaet Dresden
Department Name
Dermatologie
Principal Investigator Name
Roland Aschoff
Principal Investigator Email
roland.aschoff@ukdd.de
Contact Person Name
Roland Aschoff
Contact Person Email
roland.aschoff@ukdd.de
Site Name
Universitaetsklinikum Giessen und Marburg GmbH
Department Name
Dermatologie
Principal Investigator Name
Martin Gschnell
Principal Investigator Email
martin.gschnell@med.uni-marburg.de
Contact Person Name
Martin Gschnell
Site Name
Katholisches Klinikum Bochum gGmbH
Department Name
Dermatologie
Principal Investigator Name
Eggert Stockfleth
Principal Investigator Email
e.stockfleth@klinikum-bochum.de
Contact Person Name
Eggert Stockfleth
Site Name
Dr. Niesmann And Dr. Othlinghaus GbR
Department Name
Dermatologie
Principal Investigator Name
Johannes Niesmann
Principal Investigator Email
niesmann@niesmann-othlinghaus.de
Contact Person Name
Johannes Niesmann

Spain

Earliest CTIS Part Ii Submission Date
02-07-2024
Latest Decision Or Authorization Date
15-07-2024
Processing Time Days
13
Number Of Sites
10
Number Of Participants
106

Sites

Site Name
Hospital Universitario De Salamanca
Department Name
Dermatology
Principal Investigator Name
Javier Cañueto Alvarez
Principal Investigator Email
jcanueto@usal.es
Contact Person Name
Javier Cañueto Alvarez
Contact Person Email
jcanueto@usal.es
Site Name
Hospital Clinic De Barcelona
Department Name
Dermatology
Principal Investigator Name
Susana Puig
Principal Investigator Email
spuig@clinic.cat
Contact Person Name
Susana Puig
Contact Person Email
spuig@clinic.cat
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Dermatology
Principal Investigator Name
Montserrat Fernandez Guarino
Principal Investigator Email
Montserrat.fernandez@salud.madrid.org
Contact Person Name
Montserrat Fernandez Guarino
Site Name
Hospital Universitario Clinico San Cecilio
Department Name
Dermatology
Principal Investigator Name
Ricardo Ruiz Villaverde
Contact Person Name
Ricardo Ruiz Villaverde
Site Name
Fundacion Instituto Valenciano De Oncologia
Department Name
Dermatology
Principal Investigator Name
Carlos Serra-Guillen
Principal Investigator Email
cserra@fivo.org
Contact Person Name
Carlos Serra-Guillen
Contact Person Email
cserra@fivo.org
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Dermatology
Principal Investigator Name
David Moreno Ramirez
Contact Person Name
David Moreno Ramirez
Site Name
Hospital Unviersitario Miguel Servet
Department Name
Dermatology
Principal Investigator Name
Yolanda Gilaberte Calzada
Principal Investigator Email
ygilaberte@salud.aragon.es
Contact Person Name
Yolanda Gilaberte Calzada
Contact Person Email
ygilaberte@salud.aragon.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Dermatology
Principal Investigator Name
Carla Ferrandiz
Principal Investigator Email
carla.ferrandiz@vallhebron.cat
Contact Person Name
Carla Ferrandiz
Contact Person Email
carla.ferrandiz@vallhebron.cat
Site Name
Hospital Universitario Virgen De Las Nieves
Department Name
Dermatology
Principal Investigator Name
Francisco Vilchez Márquez
Principal Investigator Email
fvilchezm@hotmail.com
Contact Person Name
Francisco Vilchez Márquez
Contact Person Email
fvilchezm@hotmail.com
Site Name
Hospital Germans Trias I Pujol
Department Name
Dermatology
Principal Investigator Name
Maria José Fuente González
Principal Investigator Email
mjosefuente@hotmail.com
Contact Person Name
Maria José Fuente González
Contact Person Email
mjosefuente@hotmail.com

Poland

Earliest CTIS Part Ii Submission Date
02-07-2024
Latest Decision Or Authorization Date
04-08-2024
Processing Time Days
33
Number Of Sites
5
Number Of Participants
50

Sites

Site Name
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie
Department Name
Dermatology
Principal Investigator Name
Adam Reich
Principal Investigator Email
adi_medicalis@go2.pl
Contact Person Name
Adam Reich
Contact Person Email
adi_medicalis@go2.pl
Site Name
Royalderm Agnieszka Nawrocka
Department Name
Dermatology
Principal Investigator Name
Witold Owczarek
Principal Investigator Email
anawrocka@royalderm.pl
Contact Person Name
Witold Owczarek
Contact Person Email
anawrocka@royalderm.pl
Site Name
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p.
Department Name
Dermatology
Principal Investigator Name
Jacek Szepietowski
Principal Investigator Email
jacek.szepietowski@umw.edu.pl
Contact Person Name
Jacek Szepietowski
Contact Person Email
jacek.szepietowski@umw.edu.pl
Site Name
Luxderm Specjalistyczny Gabinet Dermatologiczny Prof.Dr Hab.N.Med.Dorota Krasowska
Department Name
Dermatology
Principal Investigator Name
Dorota Krasowska
Principal Investigator Email
dor.krasowska@gmail.com
Contact Person Name
Dorota Krasowska
Contact Person Email
dor.krasowska@gmail.com
Site Name
Dermmedica Sp. z o.o.
Department Name
Dermatology
Principal Investigator Name
Jolanta Weglowska
Principal Investigator Email
jolanta.weglowska@dermmedica.pl
Contact Person Name
Jolanta Weglowska

Italy

Earliest CTIS Part Ii Submission Date
02-07-2024
Latest Decision Or Authorization Date
12-01-2026
Processing Time Days
559
Number Of Sites
10
Number Of Participants
95

Sites

Site Name
Universita' Degli Studi Di Modena E Reggio Emilia
Department Name
U.O. Malattie Cutanee e Veneree
Principal Investigator Name
Francesca Farnetani
Principal Investigator Email
francesca.farnetani@unimore.it
Contact Person Name
Francesca Farnetani
Contact Person Email
francesca.farnetani@unimore.it
Site Name
Universita Degli Studi Di Brescia
Department Name
U.O.C. Dermatologia
Principal Investigator Name
Piergiacomo Calzavara Pinton
Principal Investigator Email
piergiacomo.calzavarapinton@unibs.it
Contact Person Name
Piergiacomo Calzavara Pinton
Site Name
Humanitas Mirasole S.p.A.
Department Name
UOC Dermatologia
Principal Investigator Name
Antonio Costanzo
Principal Investigator Email
antonio.costanzo@hunimed.eu
Contact Person Name
Antonio Costanzo
Contact Person Email
antonio.costanzo@hunimed.eu
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOC Dermatologia
Principal Investigator Name
Ketty Peris
Principal Investigator Email
ketty.peris@unicatt.it
Contact Person Name
Ketty Peris
Contact Person Email
ketty.peris@unicatt.it
Site Name
Azienda USL IRCCS Di Reggio Emilia
Department Name
SSD Skin Cancer Center
Principal Investigator Name
Cinzia Ricci
Principal Investigator Email
cinzia.ricci@ausl.re.it
Contact Person Name
Cinzia Ricci
Contact Person Email
cinzia.ricci@ausl.re.it
Site Name
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
UOC Dermatologia
Principal Investigator Name
Giuseppe Argenziano
Principal Investigator Email
giuseppe.argenziano@unicampania.it
Contact Person Name
Giuseppe Argenziano
Site Name
Universita Degli Studi Di Roma La Sapienza
Department Name
UOC Dermatologia
Principal Investigator Name
Giovanni Pellacani
Principal Investigator Email
pellacani.giovanni@uniroma1.it
Contact Person Name
Giovanni Pellacani
Contact Person Email
pellacani.giovanni@uniroma1.it
Site Name
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Department Name
UOC Dermatologia
Principal Investigator Name
Elena Campione
Principal Investigator Email
campioneelena@hotmail.com
Contact Person Name
Elena Campione
Contact Person Email
campioneelena@hotmail.com
Site Name
Azienda USL Toscana Sud Est
Department Name
UOC Dermatologia
Principal Investigator Name
Aldo Cuccia
Principal Investigator Email
aldo.cuccia@uslsudest.toscana.it
Contact Person Name
Aldo Cuccia
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
UOC Dermatology
Principal Investigator Name
Emanuele Cozzani
Principal Investigator Email
emanuele.cozzani@unige.it
Contact Person Name
Emanuele Cozzani
Contact Person Email
emanuele.cozzani@unige.it

Sponsor

Primary sponsor

Full Name
Almirall S.A.
Organisation Type
Pharmaceutical company
Country Of Registered Address
Spain

Contract research organisations

Name
Iqvia Inc.
Responsibilities
TSQM questionnaire
Name
Mde Services Group Limited
Responsibilities
patient expense reimbursement, investigator meeting organization
Name
Almac Clinical Services Limited
Name
TFS Trial Form Support AB

Third parties

  • {"country":"United States","full_name":"Welocalize Inc.","duties_or_roles":"translation of study documents","organisation_type":"Pharmaceutical company"}
  • {"country":"Norway","full_name":"Sunsense AS","duties_or_roles":"provision of UV sensors for patients","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Transperfect Translations International Inc.","duties_or_roles":"eTMF and study documents management","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Mapi Research Trust","duties_or_roles":"PRO licensing","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Mde Services Group Limited","duties_or_roles":"patient expense reimbursement, investigator meeting organization","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Canfield Scientific Inc.","duties_or_roles":"Collection, monitoring and archiving of clinical photographs","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Iqvia Inc.","duties_or_roles":"TSQM questionnaire","organisation_type":"Pharmaceutical company"}
  • {"country":"Sweden","full_name":"TFS Trial Form Support AB","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"CentroDerm GmbH","duties_or_roles":"skin samples and histopathology analysis","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Belgium","full_name":"S-Clinica","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Sweden","full_name":"Replior AB","duties_or_roles":"ePRO study database and patient reported outcome","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Klisyri 10 mg/g ointment
Active Substance
TIRBANIBULIN
Modality
Small molecule
Routes Of Administration
CUTANEOUS USE
Route
CUTANEOUS USE
Authorisation Status
Authorised (marketing authorisation EU/1/21/1558/001)
Maximum Dose
maxTotalDoseAmount: 30 (doseUomTotal: Other)
Investigational Product Name
Solaraze 30 mg/g Gel
Active Substance
DICLOFENAC SODIUM
Modality
Small molecule
Routes Of Administration
CUTANEOUS USE
Route
CUTANEOUS USE
Authorisation Status
Authorised (marketing authorisation 73.714)
Maximum Dose
maxDailyDoseAmount: 2; maxTotalDoseAmount: 1080; maxTreatmentPeriod: 90 (timeUnitCode: 1)

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