Clinical trial NCT06072183: A 104-Week Study of Ritlecitinib Oral Capsules in Adults With Nonsegmental Vitiligo (Active and Stable) Tranquillo 2
Official title: A PHASE 3 RANDOMIZED, DOUBLE-BLIND, 52-WEEK PLACEBO-CONTROLLED MULTI-CENTER STUDY WITH A DOUBLE-BLIND 52-WEEK EXTENSION PERIOD WITH RANDOMIZED DOSE UP/DOSE DOWN TITRATION INVESTIGATING THE EFFICACY, SAFETY, AND TOLERABILITY OF RITLECITINIB IN ADULT PARTICIPANTS WITH NONSEGMENTAL VITILIGO
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Stable Nonsegmental Vitiligo
Active Nonsegmental Vitiligo
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-10-10
Enrollment: 1201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to learn about the safety and effects of the study medicine ritlecitinib for the possible treatment of nonsegmental vitiligo. Vitiligo causes white patches on your skin when the cells that give your skin color are destroyed. Nonsegmental means that it can affect both sides of the body such as both knees and both hands.

Ritlecitinib has been tested in earlier clinical studies and has a favorable safety profile. At present there are no approved medications taken by mouth to treat nonsegmental vitiligo.

This study is seeking participants who:

* Are 18 years of age or older.
* are confirmed to have nonsegmental vitiligo for at least 3 months.
* Are willing to stop all other treatments that they may be taking for vitiligo.

In this study participants will be chosen by chance, like drawing names out of a hat to receive 1 of 3 treatments:

•Part I where two different amounts of ritlecitinib (50 mg and 100 mg) are taken once daily. It will be compared to placebo. Placebo is a dummy capsule. It doesn't have any medicine used in the study.

Participants receiving placebo who have not responded to treatment after 52 weeks will be given 100 milligrams or 50 milligrams of ritlecitinib for the remaining 52 weeks of the study.

• In Part II, participants will only receive 100 milligrams of ritlecitinib. About 1000 participants will take part in Part I and around 450 in Part II globally. The study will compare the experiences of people receiving ritlecitinib to those of the people who do not. This will help see if ritlecitinib is safe and effective.

People in Part I will be in this study for about 26 months and people in Part II will be in this study for about 14 months. During the study, participants in part I will need to visit the study site at least 17 times. In part II, participants will visit at least 11 times.

Participants will undergo various tests and procedures such as:

* vitiligo rating,
* physical examinations,
* hearing tests,
* blood tests,
* x-ray,
* ECG,
* photographs of areas with vitiligo. Participants will be asked to complete questionnaires about their vitiligo.

Detailed description: Study B7981080 is a Phase 3 randomized, double-blind, multicenter study with a 52-week placebo-controlled period (Part Ia) followed by a double-blind 52-week extension period (Part Ib) that includes randomized dose-up/down titration and a de novo 52-week non-randomized open-label cohort (Part II), investigating the efficacy, safety, and tolerability of ritlecitinib 100 mg QD and 50 mg QD compared with placebo in adult participants with nonsegmental active or stable vitiligo

Eligibility criteria: Inclusion Criteria:

1. Participants aged 18 years (or the minimum age of consent in accordance with local regulations) or older (no upper age limit) at Screening.

   • Meeting reproductive criteria for female participants.

   Disease Characteristics:
2. Eligible participants must have at both Screening and BL:

   * A clinical diagnosis of nonsegmental vitiligo for at least 3 months; and
   * BSA involvement 4% to 60% inclusive, excluding involvements at palms of the hands, soles of the feet, or dorsal aspect of the feet and
   * BSA ≥0.5% involvement on the face. Face is defined as including the area on the forehead to the original hairline, on the cheek to the jawline vertically to the jawline and laterally from the corner of the mouth to the tragus. Face will not include scalp, ears, neck, or surface area of the lips, but will include the nose and the eyelids; and
   * F-VASI ≥0.5 and T-VASI ≥3; and
   * Either active or stable nonsegmental vitiligo at Screening and BL visits. All participants who do not have the features of active vitiligo (defined below) will be classified as having stable disease.

   Active vitiligo is defined as:

   Participants will be classified as having active vitiligo based on the presence of at least one active lesion at BL defined as one of the following:
   * New/extending lesions(s) in the 3 months prior to Screening visit (confirmed by photographs or medical record);
   * Confetti-like lesion(s); Confetti-like depigmentation is characterized by the presence of numerous 1-mm to 5-mm depigmented macules in clusters;
   * Trichrome lesion(s); Trichrome lesions have a hypopigmented zone of varying width between normal and completely depigmented skin, resulting in 3 different hues of skin;
   * Koebner phenomenon/phenomena (excluding Type 1 \[history based on isomorphic reaction\]). The Koebner phenomenon manifests as depigmentation at sites of trauma, usually in a linear arrangement.

   Stable vitiligo is defined as:

   • Participants will be classified as having stable vitiligo based on an absence of signs of active disease. All participants who do not have the features of active vitiligo (defined above) will be classified as having stable disease.

   Eligibility is determined at Screening and Baseline based on the resulting scores from the local in-person reads of F-VASI, T-VASI, and BSA.
3. Additional inclusion criteria are:

   * If receiving concomitant medications for any reason other than vitiligo, participant must be on a stable regimen, which is defined as not starting a new drug or changing dosage within 7 days or 5 half-lives (whichever is longer) prior to Day 1. Participant must be willing to stay on a stable regimen during the duration of the study.
   * Must agree to stop all other treatments for vitiligo from Screening through the final follow-up visit.

Exclusion Criteria:

Medical Conditions:

1. Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.

   • Any psychiatric condition including recent or active suicidal ideation or behavior that meets defined criteria.
2. Medical conditions pertaining to vitiligo and other diseases/conditions affecting the skin:

   * Participants that have other types of vitiligo that do not meet criteria for active or stable vitiligo as noted in inclusion criteria (including but not limited to segmental vitiligo and mixed vitiligo).
   * Currently have active forms of other hypopigmentation (including but not limited to Vogt-Koyanagi-Harada disease, malignancy-induced hypopigmentation \[melanoma and mycosis fungoides\], post-inflammatory hypopigmentation, pityriasis alba \[minor manifestation of atopic dermatitis\], senile leukoderma \[age-related depigmentation\], chemical/drug-induced leukoderma, ataxia telangiectasia, tuberous sclerosis, melasma, and congenital hypopigmentation disorder including piebaldism, Waardenburg syndrome, hypomelanosis of Ito, incontinentia pigmenti, dyschromatosis symmetrica hereditarian, xeroderma pigmentosum, and nevus depigmentosus). NOTE: Coexistence of halo nevus/nevi (also known as Sutton nevus/nevi) is permitted.
   * Currently have active forms of inflammatory skin disease(s) or evidence of skin conditions (for example, but not limited to morphea, discoid lupus, leprosy, syphilis, psoriasis, seborrheic dermatitis) at the time of the Screening or BL Visit that in the opinion of the investigator would interfere with evaluation of vitiligo or response to treatment.
   * Leukotrichia in more than 33% of the face surface area affected with vitiligo lesions or leukotrichia in more than 33% of the total body surface area affected with vitiligo lesions.
   * Have a superficial skin infection within 2 weeks prior to first dose on Day 1. NOTE: participants may be rescreened after the infection resolves.
3. General Infection History:

   * Have a history of systemic infection requiring hospitalization, parenteral antimicrobial, antiviral (including biologic treatment), antiparasitic, antiprotozoal, or antifungal therapy, or as otherwise judged clinically significant by the investigator within 6 months prior to Day 1.
   * Have active acute or chronic infection requiring treatment with oral antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to Day 1. NOTE: participants may be rescreened after the infection resolves.
   * Evidence or history of untreated, currently treated or inadequately treated active or latent infection with Mycobacterium tuberculosis.
4. Specific Viral Infection History:

   * History (single episode) of disseminated HZ or disseminated herpes simplex or recurrent (more than one episode of) localized, dermatomal HZ.
   * Infected with HBV or HCV: all participants will undergo screening for HBV and HBC for eligibility.
   * Participants who are positive for HCVAb and HCV RNA will not be eligible for this study.
   * Have a known immunodeficiency disorder (including positive serology for HIV at screening) or a first-degree relative with a hereditary immunodeficiency.
5. Other Medical Conditions:

   * Current or recent history of clinically significant severe, progressive, or uncontrolled renal (including but not limited to active renal disease or recent kidney stones), hepatic, hematological, gastrointestinal, metabolic, endocrine (eg, untreated hypovitaminosis D or hypothyroidism), pulmonary, cardiovascular, psychiatric, immunologic/rheumatologic or neurologic disease; or have any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration, or interfere with the interpretation of study results; or in the opinion of the investigator or Pfizer (or designee), the participant is inappropriate for entry into this study, or unwilling/unable to comply with study procedures and lifestyle requirements.
   * History of severe allergic or anaphylactoid reaction to any kinase inhibitor or a known allergy/hypersensitivity to any component (including excipients) of the study intervention.
   * Have hearing loss with progression over the previous 5 years, sudden hearing loss, or middle or inner ear disease such as otitis media, cholesteatoma, Meniere's disease, labyrinthitis, or other auditory condition that is considered current, fluctuating, or progressive.
   * Have a history of any lymphoproliferative disorder such as EBV-related lymphoproliferative disorder, history of lymphoma, history of leukemia, or signs and symptoms suggestive of current lymphatic or lymphoid disease.
   * Abnormal findings on the Screening chest imaging (eg, chest x-ray). Chest imaging may be performed up to 12 weeks prior to screening. Documentation of the official reading must be located and available in the source documentation.
   * Long QT Syndrome, a family history of Long QT Syndrome, or a history of TdP.
   * Have any malignancies or have a history of malignancies with the exception of adequately treated or excised nonmetastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
   * Significant trauma or major surgery within 1 month of the first dose of study drug or considered in imminent need for surgery or with elective surgery scheduled to occur during the study.

   Prior/Concomitant Therapy:
6. Have received any of the prohibited treatment regimens specified.

   Prior/Concurrent Clinical Study Experience:
7. Previous administration with an investigational drug or vaccine that do not affect vitiligo within 4 weeks of Day 1 \[Baseline\] or within 5 half-lives, whichever is longer.

   Diagnostic Assessments:

   Any of the following abnormalities in clinical laboratory tests at Screening, as assessed by the study-specific laboratory and, if deemed necessary, confirmed by a single repeat:
8. Renal impairment
9. Hepatic dysfunction
10. Other laboratory abnormalities
11. Standard 12-lead ECG that demonstrates clinically relevant abnormalities

    Other Exclusion Criteria:
12. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
13. In South Africa only participants are excluded without one of the following:

    * Document evidence form a health professional of having received varicella vaccination (two doses); or
    * Evidence of prior exposure to VZV based on serological testing (ie a positive VZV IgG Ab result) at Screening.

Primary outcomes:
measure: US only Co-Primary Endpoints: Response based on Facial Vitiligo Area Scoring Index 75 (F-VASI75) at Week 52 and Total body Vitiligo Area Scoring Index 50 (T-VASI50) at Week 52
timeFrame: 52 Weeks
measure: Global (Other than US): Response based on Facial Vitiligo Area Scoring Index 75 (F-VASI75) at Week 52
timeFrame: 52 Weeks
measure: Incidence of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events (AEs) leading to discontinuation.
timeFrame: Baseline through 108 weeks
measure: Incidence of Clinically significant laboratory abnormalities.
timeFrame: Baseline through 108 weeks
Secondary outcomes:
measure: Response based on F-VASI75 at 24 and 36 weeks
timeFrame: 24 and 36 Weeks
measure: US-Only: Response based on T-VASI50 at 24 and 36 weeks
timeFrame: 24 and 36 weeks
measure: Global (Other than US):Patient Global Impression of Severity-Face (PGIS-F)
timeFrame: Week 24, 36 and week 52
measure: Global (Other than US): Patient Global Impression of Severity-Overall Vitiligo (PGIS-V)
timeFrame: Week 24, 36 and week 52
measure: Global (Other Than US): Response based on T-VASI50 at Week 24, 36 and 52
timeFrame: Week 24, 36 and 52
measure: Patient Global Impression of Change-Face (PGIC-F)
timeFrame: Week 36 and week 52
measure: Patient Global Impression of Change- Overall vitiligo(PGIC-V)
timeFrame: Week 36 and week 52
measure: Change from baseline in Dermatology Life Quality Index (DLQI)
timeFrame: Week 52
measure: Proportion of participants achieving disease stabilization
timeFrame: Baseline through week 104
measure: Response based on T-VASI50
timeFrame: Baseline through week 4, week 8, week 12, week 48, week 56, week 60, week 64, week 76, week 88 and week 104.
measure: Response based on F-VASI75
timeFrame: Baseline through week 4, week 8, week 12, week 48, week 56, week 60, week 64, week 76, week 88 and week 104.
measure: Response based on T-VASI75
timeFrame: Baseline through week 4, week 8, week 12, week 24, week 36, week 48, week 56, week 60, week 64, week 76, week 88 and week 104.
measure: Global (Other than US): Response based on T-VASI75
timeFrame: Baseline through week 52
measure: Proportion of participants with sustained improvement in T-VASI
timeFrame: Week 36 through week 52
measure: Proportion of participants with sustained improvement in F-VASI
timeFrame: Week 36 through week 52
measure: Time to rescue medication use
timeFrame: Baseline through week 104
measure: US-Only: Percentage change from baseline (% CFB) in F-VASI at Weeks 24, 36 and 52
timeFrame: Weeks 24, 36 and 52
measure: US-Only: % CFB in T-VASI at weeks 24, 36 and 52
timeFrame: Weeks 24, 36 and 52
measure: Response based on T-VASI90
timeFrame: Baseline through week 52
measure: Response based on T-VASI100
timeFrame: Baseline through week 52
measure: Response based on F-VASI50
timeFrame: Baseline through week 104
measure: Change from baseline in the Hospital Anxiety and Depression Scale (HADS)
timeFrame: Week 52
measure: The proportion of patients achieving absence of depression on HADS depression subscale
timeFrame: Week 52
measure: The proportion of patients achieving absence of anxiety on HADS anxiety subscale
timeFrame: Week 52
measure: US-Only: Patient Global Impression of Severity-Face (PGIS-F)
timeFrame: Week 52
measure: US-Only: Patient Global Impression of Severity-Overall Vitiligo (PGIS-V)
timeFrame: Week 52
measure: % CFB in F-VASI at Week 4, 8, 12, 48, 56, 60, 64, 76, 88 and 104.
timeFrame: Baseline through week 104
measure: % CFB in T-VASI at Week 4, 8, 12, 48, 56, 60, 64, 76, 88 and 104.
timeFrame: Baseline through week 104
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Center for Dermatology and Plastic Surgery/CCT Research
state: Arizona
city: Bryant
country: United States
facility: Dermatology Trial Associates
state: Arkansas
city: Fountain Valley
country: United States
facility: First OC Dermatology Research Inc
state: California
city: Huntington Beach
country: United States
facility: Seaside Audiology Vertigo & Ear Specialists
state: California
city: Los Angeles
country: United States
facility: Wallace Medical Group, Inc
state: California
city: Oakland
country: United States
facility: Kaiser Permanente
state: California
city: Oxnard
country: United States
facility: Cura Clinical Research - Oxnard
state: California
city: Rancho Santa Margarita
country: United States
facility: Mission Dermatology Center
state: California
city: Rolling Hills Estates
country: United States
facility: Peninsula Research Associates
state: California
city: Sacramento
country: United States
facility: Integrative Skin Science and Research
state: California
city: San Diego
country: United States
facility: University of California San Diego - La Jolla
state: California
city: Santa Ana
country: United States
facility: Wolverine Clinical Trials
state: California
city: Boynton Beach
country: United States
facility: Encore Medical Research of Boynton Beach
state: Florida
city: Fort Lauderdale
country: United States
facility: FXM Clinical Research - Fort Lauderdale
state: Florida
city: Hialeah
country: United States
facility: Direct Helpers Research Center
state: Florida
city: Hialeah
country: United States
facility: Harmony Medical Research Institute
state: Florida
city: Miami Lakes
country: United States
facility: Wellness Clinical Research
state: Florida
city: Miami
country: United States
facility: University of Miami Dermatology Clinical Trials Unit
state: Florida
city: Miami
country: United States
facility: Clever Medical Research
state: Florida
city: Miami
country: United States
facility: JD Medical Group
state: Florida
city: Miami
country: United States
facility: Miami Dermatology and Laser Research
state: Florida
city: Miami
country: United States
facility: SouthCoast Research Center
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Miami
country: United States
facility: Bio-Medical Research LLC
state: Florida
city: Miami
country: United States
facility: South Miami Medical & Research Group
state: Florida
city: Miami
country: United States
facility: New Horizon Research Center
state: Florida
city: Miami
country: United States
facility: Skin Research of South Florida
state: Florida
city: Miami
country: United States
facility: Well Pharma Medical Research, Corp.
state: Florida
city: Miami
country: United States
facility: FXM Clinical Research - Miami
state: Florida
city: Miami
country: United States
facility: Health and Life Research Institute
state: Florida
city: Miami
country: United States
facility: University of Miami, Kendall Office
state: Florida
city: Miami
country: United States
facility: Floridian Research Institute Llc
state: Florida
city: Miami
country: United States
facility: Sanitas Research
state: Florida
city: Miramar
country: United States
facility: FXM Clinical Research - Miramar
state: Florida
city: Saint Petersburg
country: United States
facility: GCP Research, Global Clinical professionals
state: Florida
city: Tampa
country: United States
facility: Advanced Clinical Research Institute
state: Florida
city: Tampa
country: United States
facility: USF Health
state: Florida
city: Savannah
country: United States
facility: Sidney P. Smith, MD, PC dba Georgia Skin & Cancer Clinic
state: Georgia
city: Skokie
country: United States
facility: NorthShore University Health System
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University School of Medicine - Indiana CTSI Clinical Research Center
state: Indiana
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: South Bend
country: United States
facility: The South Bend Clinic, LLC
state: Indiana
city: Rockville
country: United States
facility: Dermatology and Skin Cancer Specialists, LLC
state: Maryland
city: Auburn Hills
country: United States
facility: Oakland Hills Dermatology
state: Michigan
city: Detroit
country: United States
facility: CS Mott Center
state: Michigan
city: Detroit
country: United States
facility: Wayne Health
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Medical Center - New Center One
state: Michigan
city: Saint Joseph
country: United States
facility: MediSearch Clinical Trials
state: Missouri
city: Lincoln
country: United States
facility: Physician Research Collaboration, LLC
state: Nebraska
city: Albuquerque
country: United States
facility: University of New Mexico Health Sciences Center
state: New Mexico
city: New York
country: United States
facility: OptiSkin Medical
state: New York
city: Stony Brook
country: United States
facility: DermResearchCenter of New York, Inc.
state: New York
city: Charlotte
country: United States
facility: DJL Clinical Research, PLLC
state: North Carolina
city: Charlotte
country: United States
facility: Darst Dermatology
state: North Carolina
city: Bexley
country: United States
facility: Bexley Dermatology Research
state: Ohio
city: Dublin
country: United States
facility: Centricity Research Dublin Multispecialty
state: Ohio
city: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
city: Plymouth Meeting
country: United States
facility: Dermatology Associates of Plymouth Meeting
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Columbia
country: United States
facility: Columbia Dermatology & Aesthetics
state: South Carolina
city: Greenville
country: United States
facility: Palmetto Clinical Trial Services - Greenville
state: South Carolina
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research
state: Texas
city: Sugar Land
country: United States
facility: Complete Dermatology
state: Texas
city: The Woodlands
country: United States
facility: The Woodlands Dermatology Associates, PA
state: Texas
city: Murray
country: United States
facility: University of Utah
state: Utah
city: Springville
country: United States
facility: Springville Dermatology - Springville/CCT Research
state: Utah
city: Forest
country: United States
facility: The Education & Research Foundation, Inc.
state: Virginia
city: Phillip
country: Australia
facility: Paratus Clinical Research Woden
state: Australian Capital Territory
city: Kogarah
country: Australia
facility: St George Dermatology & Skin Cancer Centre
state: New South Wales
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Woolloongabba
country: Australia
facility: Veracity Clinical Research
state: Queensland
city: Campbelltown
country: Australia
facility: North Eastern Health Specialists
state: South Australia
city: Woodville South
country: Australia
facility: The Queen Elizabeth Hospital
state: South Australia
city: East Melbourne
country: Australia
facility: Dr Rodney Sinclair Pty Ltd
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Mitcham
country: Australia
facility: Institute for Skin, Health and Immunity
state: Victoria
city: Parkville
country: Australia
facility: The Royal Melbourne Hospital
state: Victoria
city: Fremantle
country: Australia
facility: Fremantle Dermatology
state: Western Australia
city: Brussels
country: Belgium
facility: Université Libre de Bruxelles - Hôpital Erasme
state: Bruxelles-capitale, Région DE
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
state: Bruxelles-capitale, Région DE
city: Gent
country: Belgium
facility: UZ Gent
state: Oost-vlaanderen
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-brabant
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
city: Sofia
country: Bulgaria
facility: ASMC - IPSMC - skin and venereal diseases
state: Sofia (stolitsa)
city: Sofia
country: Bulgaria
facility: Diagnostic Consultative Center Aleksandrovska
state: Sofia (stolitsa)
city: Sofia
country: Bulgaria
facility: Diagnostic Consultative Centre (DCC) - Foкus 5
state: Sofia (stolitsa)
city: Sofia
country: Bulgaria
facility: Clinic EvroDerma
state: Sofia (stolitsa)
city: Pazardzhik
country: Bulgaria
facility: MHAT Pazardzhik
city: Pernik
country: Bulgaria
facility: Diagnostic Consultative Center 1 - Pernik
city: Pleven
country: Bulgaria
facility: Medical Center Exacta Medica
city: Ruse
country: Bulgaria
facility: Medical Center Prolet EOOD
city: Sofia
country: Bulgaria
facility: Diagnostic Consultative Center "Ascendent"
city: Sofia
country: Bulgaria
facility: Diagnostic - Consultative Center XXVIII - Sofia
city: Sofia
country: Bulgaria
facility: "Diagnostic - Consultative Center XX - Sofia" EOOD
city: Stara Zagora
country: Bulgaria
facility: UMHAT "Prof. Dr. Stoyan Kirkovich"AD
city: Veliko Tarnovo
country: Bulgaria
facility: Center for Skin and Venereal Diseases - Veliko Tarnovo
city: Yambol
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Sv. Panteleymon - Yambol AD
city: Calgary
country: Canada
facility: Dermatology Research Institute
state: Alberta
city: Edmonton
country: Canada
facility: Alberta Dermasurgery Centre
state: Alberta
city: Vancouver
country: Canada
facility: The Skin Care Centre
state: British Columbia
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research Inc.
state: Manitoba
city: Barrie
country: Canada
facility: SimcoDerm Medical and Surgical Dermatology Center
state: Ontario
city: London
country: Canada
facility: DermEffects
state: Ontario
city: Mississauga
country: Canada
facility: DermEdge Research
state: Ontario
city: Oakville
country: Canada
facility: The Centre for Clinical Trials
state: Ontario
city: Ottawa
country: Canada
facility: JRB Research Inc.
state: Ontario
city: Richmond Hill
country: Canada
facility: York Dermatology Clinic & Research Centre
state: Ontario
city: Sudbury
country: Canada
facility: Medicor Research Inc
state: Ontario
city: Sudbury
country: Canada
facility: Sudbury Skin Clinique
state: Ontario
city: Toronto
country: Canada
facility: North York Research Inc
state: Ontario
city: Toronto
country: Canada
facility: Dermatology on Bloor - Research Toronto
state: Ontario
city: Montréal
country: Canada
facility: Centre de Recherche Saint-Louis
state: Quebec
city: Montréal
country: Canada
facility: Innovaderm Research Inc.
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre de Recherche Saint-Louis
state: Quebec
city: Sherbrooke
country: Canada
facility: Diex Recherche Sherbrooke
state: Quebec
city: Saskatoon
country: Canada
facility: Skinsense Medical Research
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Saskatoon Dermatology Centre
state: Saskatchewan
city: Quebec
country: Canada
facility: Diex Recherche Quebec
city: Quebec
country: Canada
facility: Centre de Recherche Dermatologique du Quebec metropolitain
city: Quebec
country: Canada
facility: Alpha Recherche Clinique
city: Beijing
country: China
facility: Beijing Friendship Hospital Affiliate of Capital University
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Fuzhou
country: China
facility: The First Affiliated Hospital Of Fujian Medical University
state: Fujian
city: Guangzhou
country: China
facility: Dermatology Hospital of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
state: Guangdong
city: Guiyang
country: China
facility: The Affiliated Hospital of Guizhou Medical University
state: Guizhou
city: Shijiazhuang
country: China
facility: The First Hospital of Hebei Medical University
state: Hebei
city: Nanyang
country: China
facility: NanYang First people's hospital
state: Henan
city: Wuhan
country: China
facility: The First Hospital of Wuhan
state: Hubei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Baotou
country: China
facility: The First Affiliated Hospital of Baotou Medical College
state: Inner Mongolia
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University
state: Shanghai
city: Cheng Du
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Chengdu
country: China
facility: Chengdu second people's hospital
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Kunming
country: China
facility: First Affiliated Hospital of Kunming Medical University
state: Yunnan Sheng
city: Hangzhou
country: China
facility: Hangzhou Third Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Shanghai
country: China
facility: Shanghai General Hospital
city: Darmstadt
country: Germany
facility: Rosenpark Research GmbH
state: Hessen
city: Bielefeld
country: Germany
facility: Klinikum Bielefeld gem. GmbH
state: Nordrhein-westfalen
city: Bielefeld
country: Germany
facility: Klinikum Bielefeld Rosenhöhe
state: Nordrhein-westfalen
city: Bochum
country: Germany
facility: Hautzentrum im Jahrhunderthaus
state: Nordrhein-westfalen
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
state: Nordrhein-westfalen
city: Mainz
country: Germany
facility: BAG Drs. Med. Quist PartG
state: Rheinland-pfalz
city: Magdeburg
country: Germany
facility: HNO-Praxis Dr. Kugler in Magdeburg
state: Sachsen-anhalt
city: Magdeburg
country: Germany
facility: Magdeburger Company for Medical Studies and Services
state: Sachsen-anhalt
city: Magdeburg
country: Germany
facility: Radiologie Ulrichshaus
state: Sachsen-anhalt
city: Dresden
country: Germany
facility: Hautarztpraxis Dr. Gerlach
state: Sachsen
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus Dresden
state: Sachsen
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus Dresden
state: Sachsen
city: Leipzig
country: Germany
facility: Hautarztpraxis Dr. Neubauer
state: Sachsen
city: Pécs
country: Hungary
facility: Pécsi Tudományegyetem Klinikai Központ
state: Baranya
city: Gyula
country: Hungary
facility: Synexus Magyarorszag Kft. (Gyula DRS)
state: Békés
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
state: Csongrád
city: Szolnok
country: Hungary
facility: Allergo-Derm Bakos Kft
state: Jász-nagykun-szolnok
city: Budapest
country: Hungary
facility: Óbudai Egészségügyi Centrum
city: Debrecen
country: Hungary
facility: Orvostudomanyi Kutato es Fejleszto Kft
city: Debrecen
country: Hungary
facility: DERMA-B Egészségügyi és Szolgáltató
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Kaposvár
country: Hungary
facility: Derm-Surg Kft.
city: L'Aquila
country: Italy
facility: ASL1 Avezzano-Sulmona-L'Aquila
state: Abruzzo
city: Florence
country: Italy
facility: Presidio Ospedaliero Firenze Centro Piero Palagi
state: Firenze
city: Milano
country: Italy
facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
state: Lombardia
city: Roma
country: Italy
facility: IRCCS Istituti Fisioterapici Ospitalieri
state: RM
city: Rome
country: Italy
facility: Ospedale Israelitico
state: Roma
city: Rome
country: Italy
facility: Istituto Dermopatico Immacolata
state: Roma
city: Cagliari
country: Italy
facility: Ospedale Civile - Azienda Ospedaliera Universitaria di Cagliari
city: Cagliari
country: Italy
facility: Ospedale Civile - Azienda Ospedaliera Universitaria di Cagliari
city: Nagoya
country: Japan
facility: Japan Community Health Care Organization Chukyo Hospital
state: Aichi
city: Sakura
country: Japan
facility: Toho University Sakura Medical Center
state: Chiba
city: Urayasu
country: Japan
facility: Juntendo University Urayasu Hospital
state: Chiba
city: Takarazuka
country: Japan
facility: Takarazuka City Hospital
state: Hyōgo
city: Inashiki-gun
country: Japan
facility: Tokyo Medical University Ibaraki Medical Center
state: Ibaraki
city: Ikoma City
country: Japan
facility: Kindai University Nara Hospital
state: Nara
city: Habikino
country: Japan
facility: Osaka Habikino Medical Center
state: Osaka
city: Hamamatsu-shi
country: Japan
facility: Hamamatsu University Hospital
state: Shizuoka
city: Bunkyo-ku
country: Japan
facility: Institute of Science Tokyo Hospital
state: Tokyo
city: Ube
country: Japan
facility: Yamaguchi University Hospital
state: Yamaguchi
city: Mexico City
country: Mexico
facility: Trials in Medicine
state: Distrito Federal
city: Morelia
country: Mexico
facility: Clinica de Enfermedades Cronicas y Procedimientos Especiales, SC
state: Michoacan
city: Monterrey
country: Mexico
facility: Centro Regiomontano de Investigación
state: Nuevo LEÓN
city: Chihuahua
country: Mexico
facility: Servicios Hospitalarios de Mexico S.A. DE C.V.
city: Durango
country: Mexico
facility: Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
city: Veracruz
country: Mexico
facility: Arké SMO S.A de C.V
city: Bydgoszcz
country: Poland
facility: Clinica Dermatoestetica Prywatny Gabinet Dermatologiczny I Alergologiczny Prof.Dr Hab.Med. Barbara Z
state: Kujawsko-pomorskie
city: Warszawa
country: Poland
facility: ETG Warszawa
state: Mazowieckie
city: Warszawa
country: Poland
facility: Klinika Ambroziak Dermatologia
state: Mazowieckie
city: Warszawa
country: Poland
facility: Royalderm Agnieszka Nawrocka
state: Mazowieckie
city: Krakow
country: Poland
facility: Krakowskie Centrum Medyczne
state: Małopolskie
city: Kraków
country: Poland
facility: Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy, Marek Brzewski, Paweł Brzewski spółka
state: Małopolskie
city: Bialystok
country: Poland
facility: Specderm Poznanska sp.j.
state: Podlaskie
city: Bialystok
country: Poland
facility: ClinicMed Daniluk, Nowak Spółka komandytowa
state: Podlaskie
city: Szczecin
country: Poland
facility: Twoja Przychodnia SCM
state: Zachodniopomorskie
city: Lodz
country: Poland
facility: "DERMED" Centrum Medyczne Sp. z o.o.
state: Łódzkie
city: Katowice
country: Poland
facility: Centrum Medyczne Angelius Provita
state: Śląskie
city: San Juan
country: Puerto Rico
facility: Cardiovascular Radiology Institute
city: San Juan
country: Puerto Rico
facility: Clinical Research Puerto Rico
city: San Juan
country: Puerto Rico
facility: Centro de Audiología y Balance
city: Banska Bystrica
country: Slovakia
facility: Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica
state: Banskobystrický KRAJ
city: Svidnik
country: Slovakia
facility: SANARE, s.r.o
state: Prešovský KRAJ
city: Trnava
country: Slovakia
facility: Fakultna nemocnica Trnava
state: Trnavský KRAJ
city: Bratislava
country: Slovakia
facility: CLINIQ s.r.o.
city: Bratislava
country: Slovakia
facility: BeneDerma
city: Bratislava
country: Slovakia
facility: Derma therapy spol. s.r.o.
city: Kosice
country: Slovakia
facility: Topskin pro s.r.o.
city: Kosice
country: Slovakia
facility: Poliklinika ProCare Kosice s.r.o.
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
state: Andalucía
city: Córdoba
country: Spain
facility: AUDIKA
state: Andalucía
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona [barcelona]
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona [barcelona]
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
state: Catalunya [cataluña]
city: Santiago de Compostela
country: Spain
facility: Clínica Gaias - Santiago
state: Galicia [galicia]
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
state: Madrid, Comunidad DE
city: Madrid
country: Spain
facility: Clinica Universidad de Navarra
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Santiago de Compostela
country: Spain
facility: Clínica Gaias - Santiago
city: València
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Kaohsiung Niao Sung Dist
country: Taiwan
facility: Chang Gung Memorial Hospital at Kaohsiung
state: Kaohsiung
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou Branch
city: Ankara
country: Turkey
facility: Gazi University Health Research and Application Center Gazi Hospital
city: Istanbul
country: Turkey
facility: Bezmialem Vakf Üniversitesi
city: Isleworth
country: United Kingdom
facility: West Middlesex University Hospital
state: England
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
state: Hampshire
city: London
country: United Kingdom
facility: Guy's & St Thomas' NHS Foundation Trust
state: London, CITY OF
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: