Observational Evaluation of Atopic Dermatitis in Pediatric Patients (PEDISTAD)

Prospective, Observational, Longitudinal Study in Pediatric Patients With Moderate to Severe Atopic Dermatitis Whose Disease is Not Adequately Controlled With Topical Prescription Therapies or When Those Therapies Are Not Medically Advisable

Primary Objectives:

• To describe the characteristics of pediatric patients with moderate to severe atopic dermatitis (AD) whose disease is not adequately controlled with topical therapies or when those therapies are not medically advisable.
• To evaluate the time-course of AD and selected atopic comorbidities.

Secondary Objectives:

• To characterize disease burden and unmet need.
• To describe real-world treatment patterns (eg, dosing regimens, treatment duration, and reasons for discontinuation and/or switching).
• To document the real-world effectiveness and safety of treatments.

Study Overview

• Status: Active, not recruiting
• Conditions: Dermatitis Atopic
• Intervention / Treatment: Other: Standard of care

Detailed Description

The study duration is 120 months.

• Study Type: Observational
• Enrollment (Actual): 1860

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1121
    • Investigational Site Number : 0320001
  • Buenos Aires, Argentina, 1056
    • Investigational Site Number : 0320006
  • Buenos Aires, Argentina, 1181
    • Investigational Site Number : 0320002
  • Buenos Aires, Argentina, 1181
    • Investigational Site Number : 0320008
  • Ciudad Autonoma Buenos Aires, Argentina, C1270AAN
    • Investigational Site Number : 0320005
  • Cordoba, Argentina, 5000
    • Investigational Site Number : 0320010
  • Salta, Argentina, A4400
    • Investigational Site Number : 0320013
  • San Miguel de Tucuman, Argentina, T4000AXL
    • Investigational Site Number : 0320007
  • Buenos Aires
    • Bahía Blanca, Buenos Aires, Argentina, 8000
      • Investigational Site Number : 0320009
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1425BEA
      • Investigational Site Number : 0320003
  • Santa Fe
    • Rosario, Santa Fe, Argentina, 2000
      • Investigational Site Number : 0320004
  • Tucumán
    • San Miguel de Tucumán, Tucumán, Argentina, 4000
      • Investigational Site Number : 0320007
• Australia
  • New South Wales
    • Kogarah, New South Wales, Australia, 2217
      • Investigational Site Number : 0360008
    • Sydney, New South Wales, Australia, 2010
      • Investigational Site Number : 0360011
    • Sydney, New South Wales, Australia, 2560
      • Investigational Site Number : 0360009
  • Victoria
    • Melbourne, Victoria, Australia, 3128
      • Investigational Site Number : 0360010
    • Parkville, Victoria, Australia, 3052
      • Investigational Site Number : 0360003
    • Richmond, Victoria, Australia, 3121
      • Investigational Site Number : 0360007
• Brazil
  • Rio de Janeiro, Brazil, 22470-220
    • IDERJ - Instituto de Dermatologia e Estética do Brasil- Site Number : 0760009
  • Sao Jose Rio Preto, Brazil, 15090-000
    • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto- Site Number : 0760007
  • São Paulo, Brazil, 04037-002
    • Hospital Sao Paulo- Site Number : 0760006
  • Paraná
    • Curitiba, Paraná, Brazil, 80060-000
      • Universidade Federal do Paraná- Site Number : 0760003
    • Curitiba, Paraná, Brazil, 80060-900
      • Hospital de Clinicas da Universidade Federal do Parana- Site Number : 0760004
    • Curitiba, Paraná, Brazil, 80060-900
      • Hospital de Clinicas da Universidade Federal do Parana- Site Number : 0760005
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90020-090
      • Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760002
  • São Paulo
    • Sorocaba, São Paulo, Brazil, 18040-425
      • Clinica de Alergia Martti Antila- Site Number : 0760001
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3B 6A8
      • Investigational Site Number : 1240007
    • Calgary, Alberta, Canada, T3A 2N1
      • Investigational Site Number : 1240004
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3C ON2
      • Investigational Site Number : 1240005
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3K 5R3
      • Investigational Site Number : 1240010
  • Ontario
    • Markham, Ontario, Canada, L3P 1X2
      • Investigational Site Number : 1240001
    • Toronto, Ontario, Canada, M5G 1X8
      • Investigational Site Number : 1240008
  • Quebec
    • Montreal, Quebec, Canada, H3T 1C5
      • Investigational Site Number : 1240006
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4V 1R9
      • Investigational Site Number : 1240009
• China
  • Beijing, China, 100045
    • Investigational Site Number : 1560004
  • Changsha, China, 410007
    • Investigational Site Number : 1560006
  • Chongqing, China, 400014
    • Investigational Site Number : 1560001
  • Guangzhou, China, 510018
    • Investigational Site Number : 1560012
  • Harbin, China, 150010
    • Investigational Site Number : 1560007
  • Shanghai, China, 201102
    • Investigational Site Number : 1560005
  • Shenzhen, China, 518020
    • Investigational Site Number : 1560011
  • Suzhou, China, 215025
    • Investigational Site Number : 1560002
  • Xuzhou, China, 221002
    • Investigational Site Number : 1560008
• Colombia
  • Barranquilla, Colombia, 080002
    • Investigational Site Number : 1700006
  • Bogota, Colombia, 110111
    • Investigational Site Number : 1700001
  • Bogota, Colombia, 111211
    • Investigational Site Number : 1700004
• Denmark
  • Kobenhavn Nv, Denmark, 2400
    • Investigational Site Number : 2080002
• France
  • Argenteuil Cedex, France, 95107
    • Investigational Site Number : 2500008
  • Bordeaux, France, 33800
    • Investigational Site Number : 2500001
  • Lille cedex, France, 59020
    • Investigational Site Number : 2500010
  • Marseille cedex 5, France, 13385
    • Investigational Site Number : 2500006
  • Martigues, France, 13500
    • Investigational Site Number : 2500005
  • Nantes, France, 44093
    • Investigational Site Number : 2500002
  • Paris cedex 15, France, 75015
    • Investigational Site Number : 2500003
  • Toulouse Cedex 9, France, 31059
    • Investigational Site Number : 2500011
• Greece
  • Larissa, Greece, 411 10
    • Investigational Site Number : 3000004
  • Thessaloniki, Greece, 54642
    • Investigational Site Number : 3000005
  • Thessaloniki, Greece, 54643
    • Investigational Site Number : 3000003
  • Thessaloniki, Greece, 564 29
    • Investigational Site Number : 3000002
• Israel
  • Be'er Sheva, Israel, 8457108
    • Investigational Site Number : 3760003
  • Haifa, Israel, 3104802
    • Investigational Site Number : 3760004
  • Kefar Sava, Israel, 4428164
    • Investigational Site Number : 3760005
  • Ramat Gan, Israel, 5262100
    • Investigational Site Number : 3760001
  • Rehovot, Israel, 7610001
    • Investigational Site Number : 3760002
• Italy
  • Bari, Italy, 70124
    • Investigational Site Number : 3800012
  • Bologna, Italy, 40138
    • Investigational Site Number : 3800003
  • Brescia, Italy, 25123
    • Investigational Site Number : 3800014
  • Catania, Italy, 95123
    • Investigational Site Number : 3800010
  • Milano, Italy, 20122
    • Investigational Site Number : 3800001
  • Napoli, Italy, 80131
    • Investigational Site Number : 3800005
  • Pavia, Italy, 27100
    • Investigational Site Number : 3800015
  • Perugia, Italy, 06129
    • Investigational Site Number : 3800009
  • Reggio Emilia, Italy, 42100
    • Investigational Site Number : 3800013
  • Roma, Italy, 00137
    • Investigational Site Number : 3800018
  • Trieste, Italy, 34137
    • Investigational Site Number : 3800007
  • Latina
    • Terracina, Latina, Italy, 04019
      • Investigational Site Number : 3800004
  • Napoli
    • Naples, Napoli, Italy, 80131
      • Investigational Site Number : 3800008
  • Padova
    • Padua, Padova, Italy, 35128
      • Investigational Site Number : 3800011
  • Veneto
    • Padua, Veneto, Italy, 35128
      • Investigational Site Number : 3800006
• Japan
  • Fukuoka-shi, Japan, 813-0017
    • Investigational Site Number : 3920018
  • Fukuyama-shi, Japan, 721-8511
    • Investigational Site Number : 3920017
  • Hiroshima, Japan, 734-8551
    • Investigational Site Number : 3920002
  • Kumagaya-shi, Japan, 360-0018
    • Investigational Site Number : 3920015
  • Kyoto, Japan, 602-8566
    • Investigational Site Number : 3920004
  • Nagasaki, Japan, 852-8501
    • Investigational Site Number : 3920012
  • Nagoya-shi, Japan, 460-0001
    • Investigational Site Number : 3920020
  • Obu-shi, Japan, 474-8710
    • Investigational Site Number : 3920008
  • Osakasayama-shi, Japan, 589-8511
    • Investigational Site Number : 3920005
  • Sendai-shi, Japan, 983-8512
    • Investigational Site Number : 3920014
  • Sendai-shi, Japan, 989-3126
    • Investigational Site Number : 3920019
  • Tokyo, Japan, 157-8535
    • Investigational Site Number : 3920001
  • Yokohama-shi, Japan, 221-0825
    • Investigational Site Number : 3920016
  • Kanagawa
    • Sagamihara, Kanagawa, Japan, 252-0315
      • Investigational Site Number : 3920009
    • Yokohama, Kanagawa, Japan, 221-0825
      • Investigational Site Number : 3920016
  • Mie
    • TSU, Mie, Japan, 514-0125
      • Investigational Site Number : 3920010
  • Osaka
    • Habikino, Osaka, Japan, 583-8588
      • Investigational Site Number : 3920003
  • Tokyo
    • Fuchu, Tokyo, Japan, 183-8561
      • Investigational Site Number : 3920011
• Korea, Republic of
  • Seoul, Korea, Republic of, 01757
    • Investigational Site Number : 4100001
  • Seoul, Korea, Republic of, 02447
    • Investigational Site Number : 4100003
  • Seoul, Korea, Republic of, 05505
    • Investigational Site Number : 4100005
  • Seoul, Korea, Republic of, 06351
    • Investigational Site Number : 4100004
  • Gyeonggi-do
    • Ansan-si, Gyeonggi-do, Korea, Republic of, 15355
      • Investigational Site Number : 4100008
    • Suwon-si, Gyeonggi-do, Korea, Republic of, 16499
      • Investigational Site Number : 4100002
  • Incheon-gwangyeoksi
    • Incheon, Incheon-gwangyeoksi, Korea, Republic of, 21565
      • Investigational Site Number : 4100007
• Mexico
  • Mexico, Mexico, 06720
    • Investigational Site Number : 4840006
  • Mexico, Mexico, 04530
    • Investigational Site Number : 4840001
  • Puebla, Mexico, 72190
    • Investigational Site Number : 4840004
  • Tlalnepantla de Baz, Mexico, 54055
    • Investigational Site Number : 4840005
  • Morelos
    • Cuernavaca, Morelos, Mexico, 62290
      • Investigational Site Number : 4840010
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64460
      • Investigational Site Number : 4840003
    • Monterrey, Nuevo León, Mexico, 64460
      • Investigational Site Number : 4840009
    • Monterrey, Nuevo León, Mexico, 64718
      • Investigational Site Number : 4840008
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Investigational Site Number : 5280001
  • Den Haag, Netherlands, 2566 MJ
    • Investigational Site Number : 5280006
  • Groningen, Netherlands, 9713 GR
    • Investigational Site Number : 5280005
  • Rotterdam, Netherlands, 3015 CE
    • Investigational Site Number : 5280002
  • Utrecht, Netherlands, 3508 GA
    • Investigational Site Number : 5280003
• Norway
  • Bergen, Norway, 5021
    • Investigational Site Number : 5780001
  • Oslo, Norway, 0027
    • Investigational Site Number : 5780002
  • Stavanger, Norway, 4011
    • Investigational Site Number : 5780003
• Portugal
  • Braga, Portugal, 4710-243
    • Investigational Site Number : 6200003
  • Lisboa, Portugal, 1649-035
    • Investigational Site Number : 6200001
  • Lisboa, Portugal, 1169-050
    • Investigational Site Number : 6200005
  • Porto, Portugal, 4200-319
    • Investigational Site Number : 6200006
• Russian Federation
  • Moscow, Russian Federation, 109240
    • Investigational Site Number : 6430005
  • Moscow, Russian Federation, 115478
    • Investigational Site Number : 6430002
  • Moscow, Russian Federation, 117513
    • Investigational Site Number : 6430003
  • Moscow, Russian Federation, 119991
    • Investigational Site Number : 6430001
  • Moscow, Russian Federation, 125373
    • Investigational Site Number : 6430004
• Spain
  • Barcelona, Spain, 08003
    • Investigational Site Number : 7240011
  • Barcelona, Spain, 08041
    • Investigational Site Number : 7240002
  • Madrid, Spain, 28007
    • Investigational Site Number : 7240003
  • Madrid, Spain, 28041
    • Investigational Site Number : 7240010
  • Asturias
    • Mieres, Asturias, Spain, 33611
      • Investigational Site Number : 7240009
  • Catalunya [Cataluña]
    • Barcelona, Catalunya [Cataluña], Spain, 08950
      • Investigational Site Number : 7240005
  • Madrid
    • Pozuelo de Alarcón, Madrid, Spain, 28223
      • Investigational Site Number : 7240012
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • C Squared Research Center- Site Number : 8400068
    • Birmingham, Alabama, United States, 35244
      • Cahaba Dermatology & Skin Health Center- Site Number : 8400046
    • Montgomery, Alabama, United States, 36117
      • C2 Research Center, LLC- Site Number : 8400071
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Phoenix Children's Hospital, Inc.- Site Number : 8400015
  • California
    • Anaheim, California, United States, 92801
      • Orange County Research Institute- Site Number : 8400028
    • Los Angeles, California, United States, 90036
      • Axis Clinical Trials- Site Number : 8400025
    • Madera, California, United States, 93637
      • Madera Family Medical Group- Site Number : 8400054
    • Ventura, California, United States, 93003
      • Carey Chronis, MD, FAAP- Site Number : 8400033
  • Florida
    • Boca Raton, Florida, United States, 33431
      • Daxia Trials- Site Number : 8400082
    • Boca Raton, Florida, United States, 33487
      • Frieder Dermatology- Site Number : 8400085
    • Coral Gables, Florida, United States, 33146
      • Pediatric Center of Excellence (PCE) - Miami Pediatric Endocrinology, LLC- Site Number : 8400072
    • Deerfield Beach, Florida, United States, 33441
      • Green Dermatology and Cosmetic Center. Site Number : 8400078
    • Hialeah, Florida, United States, 33013
      • Amedica Research Institute, Inc.- Site Number : 8400067
    • Hialeah, Florida, United States, 33013
      • Eastern Research, Inc.- Site Number : 8400032
    • Miami, Florida, United States, 33137
      • Premier Dermatology Partners- Site Number : 8400075
    • Miami, Florida, United States, 33155
      • Nicklaus Children's Hospital - Miami - Southwest 62nd Avenue- Site Number : 8400074
    • Miami, Florida, United States, 33176
      • Vista Health Research, LLC- Site Number : 8400034
    • Orlando, Florida, United States, 32825
      • Pediatric & Adult Research Center- Site Number : 8400040
    • Pembroke Pines, Florida, United States, 33024
      • Elias Dermatology LLC- Site Number : 8400086
    • Pembroke Pines, Florida, United States, 33024
      • Elias Dermatology LLC- Site Number : 8400087
  • Georgia
    • Columbus, Georgia, United States, 31904
      • Centricity Research Talbotton - DBA IACT Health Research at Talbotton Site Number : 8400056
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Feinberg School of Medicine- Site Number : 8400001
    • Skokie, Illinois, United States, 60077
      • NorthShore University HealthSystem - Skokie- Site Number : 8400064
  • Indiana
    • Plainfield, Indiana, United States, 46168
      • The Indiana Clinical Trial Center - Plainfield - Edwards Drive- Site Number : 8400007
    • Plainfield, Indiana, United States, 46168
      • The Indiana Clinical Trials Center, PC Site Number : 8400007
  • Kentucky
    • Lexington, Kentucky, United States, 40517
      • Michael W. Simon, M.D., PSC- Site Number : 8400073
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Dermatology Associates PC- Site Number : 8400049
  • Michigan
    • Waterford, Michigan, United States, 48328
      • Michigan Dermatology Institute Site Number : 8400059
  • New Jersey
    • Irvington, New Jersey, United States, 07111
      • Tokunbo T. Dada, MD PA- Site Number : 8400079
    • Newark, New Jersey, United States, 07104
      • Family Pediatrics Iwuozo L Obilo Md- Site Number : 8400077
    • North Plainfield, New Jersey, United States, 07060
      • Providence Medical Center- Site Number : 8400081
    • Union, New Jersey, United States, 07083-5714
      • VAMA Medical Health Center- Site Number : 8400083
  • New York
    • Bronx, New York, United States, 10463
      • Philip Fried, M.D., PLLC- Site Number : 8400029
    • Bronx, New York, United States, 10463
      • Tiga Pediatrics, PC- Site Number : 8400037
    • New York, New York, United States, 10019
      • Park Plaza Dermatology- Site Number : 8400080
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • UNC Hospitals- Site Number : 8400016
    • Durham, North Carolina, United States, 27713
      • 2G Clinical Research Services- Site Number : 8400031
    • Gastonia, North Carolina, United States, 28054
      • Clinical Research Of Gastonia- Site Number : 8400041
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center- Site Number : 8400017
    • Marion, Ohio, United States, 43302
      • Dermatology Associates of Mid-Ohio- Site Number : 8400052
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • MUSC- Site Number : 8400013
    • Greenville, South Carolina, United States, 29607
      • ADAC Research- Site Number : 8400048
  • Texas
    • Amarillo, Texas, United States, 79124
      • Amarillo Center for Clinical Research- Site Number : 8400055
    • Houston, Texas, United States, 77008
      • Heights Dermatology & Aesthetic Center- Site Number : 8400065
    • McAllen, Texas, United States, 78501
      • The Dermatology Institute of South Texas- Site Number : 8400076
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College Of Wisconsin- Site Number : 8400008

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 11 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Pediatric patients with moderate to severe AD whose disease is not adequately controlled with topical therapies or when those therapies are not medically advisable.

Description

Inclusion criteria:

• Patients with moderate to severe AD, according to the Investigator's assessment;
• Currently receiving systemic treatment (including phototherapy) for atopic dermatitis or currently on topical treatment, but otherwise candidates for systemic treatment.

Exclusion criteria:

• Concurrent participation in an interventional clinical trial which modifies patient care.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants with atopic dermatitis (AD); Participants receive AD therapy as part of their usual care as determined by their physician independent of decision to enroll in the study.	Other: Standard of care; Treatment as per standard practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Patient demographics	Baseline (Month 0)
Medical history of selected atopic diseases and comorbidities	Baseline (Month 0)
Age at onset of atopic dermatitis (AD)	Baseline (Month 0)
Personal and family history of AD and selected atopic diseases	Baseline (Month 0)
All prior and current systemic AD treatment	Baseline (Month 0)
All prior and current topical therapy and phototherapy for AD (including dose, route and frequency of administration for all AD treatment)	Baseline (Month 0)
Presence/severity of AD and selected atopic comorbid conditions	Baseline to Month 120
Therapy for selected atopic comorbid conditions	Baseline to Month 120

Secondary Outcome Measures

Outcome Measure	Time Frame
Days missed from school for the patient and days missed from work for the primary caregiver due to AD	Baseline to Month 120
Visits to healthcare professionals (HCPs)	Baseline to Month 120
Treatments and prescribing patterns for pediatric AD	Baseline to Month 120
Changes in physician assessment of disease burden (Eczema Area and Severity Index [EASI])	Baseline to Month 120
Changes in physician assessment of disease burden (Body Surface Area [BSA])	Baseline to Month 120
Changes in patient/caregiver-reported outcome (PRO): Patient-Oriented Eczema Measure (POEM)	Baseline to Month 120
Change in PRO: Children's Dermatology Life Quality Index (CDLQI)/ Infant's Dermatitis Quality of Life (IDQOL)	Baseline to Month 120
Change in PRO: Dermatitis Family Impact (DFI)	Baseline to Month 120
Change in PRO: Peak Pruritus Numerical Rating Scale (NRS)/ Pruritus (Itch) NRS/ Worst scratching NRS	Baseline to Month 120
Change in PRO: Caregiver Global Assessment of Disease (CGAD)	Baseline to Month 120
Change in PRO: Days missed from school for the patient and days missed from work for the primary caregiver due to AD since last visit	Baseline to Month 120
Change in PRO: Total Nasal Symptom Score (TNSS)	Baseline to Month 120
Change in PRO: Pediatric Asthma Questionnaire (PAQ)	Baseline to Month 120
Change in PRO: Juniper Asthma Control Questionnaire-5 (ACQ-5)	Baseline to Month 120
Adverse event (AE) reporting	Baseline to Month 120

Collaborators and Investigators

• Sponsor: Sanofi
• Investigators: Study Director: Clinical Sciences & Operations, Sanofi

Publications and helpful links

General Publications

• Paller AS, Guttman-Yassky E, Irvine AD, Baselga E, de Bruin-Weller M, Jayawardena S, Zhang A, Mina-Osorio P, Rizova E, Ozturk ZE. Protocol for a prospective, observational, longitudinal study in paediatric patients with moderate-to-severe atopic dermatitis (PEDISTAD): study objectives, design and methodology. BMJ Open. 2020 Mar 24;10(3):e033507. doi: 10.1136/bmjopen-2019-033507.

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2019
• Primary Completion (Estimated): July 23, 2035
• Study Completion (Estimated): July 23, 2035

Study Registration Dates

• First Submitted: September 6, 2018
• First Submitted That Met QC Criteria: September 25, 2018
• First Posted (Actual): September 27, 2018

Study Record Updates

• Last Update Posted (Estimated): August 15, 2025
• Last Update Submitted That Met QC Criteria: August 14, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis, Atopic; Dermatitis
• Other Study ID Numbers: OBS15333; U1111-1211-9437 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No