Generated Narrative: ResearchStudy

identifier: id: NCT03240627

title: Double-blind, Vehicle-controlled, Randomised, Multi-centre Study to Evaluate the Efficacy and Safety of LH-8 Cutaneous Solution in Children and Adolescents With Moderate to Severe Scalp Alopecia Areata.

status: completed

primaryPurposeType: Treatment (ResearchStudyPrimaryPurposeType#treatment)

phase: Phase 2/Phase 3 (ResearchStudyPhase#phase-2-phase-3)

category: Interventional Study (NCI Thesaurus#C98388), Randomized Controlled Clinical Trial (NCI Thesaurus#C46079), Double Blind Study (NCI Thesaurus#C15228), Unequal Randomization (NCI Thesaurus#C142743)

focus: Pharmacologic Substance (NCI Thesaurus#C1909)

condition: Alopecia areata (disorder) (SNOMED CT#68225006)

location: Germany (ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code#DE), France (ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code#FR)

period: 2018-03-01 --> 2022-03-17

principalInvestigator: Practitioner/example

site:

• Organization/Charite-dermatology
• Organization/Sabouraud-Center
• Organization/Diagnostic-consulting-center-XXIV-Sofia
• Organization/SC-Centrul-Medical-Sana-SRL

arm

name: Experimental: LH-8 cutaneous solution

type: Investigational Arm (NCI Thesaurus#C174266)

description: LH-8 cutaneous solution (0.126 mL per spray) applied to the whole scalp

arm

name: Placebo Comparator: Placebo cutaneous solution

type: Control Arm (NCI Thesaurus#C174226)

description: Placebo cutaneous solution (0.126 mL per spray) applied to the whole scalp

objective

name: Relative change in scalp alopecia areata severity scores (SALT) from baseline value to be assessed after 24 weeks of treatment. [ Time Frame: 24 weeks treatment ] Visual assessment and global standardised scalp photographs for SALT evaluation.

type: Primary (ResearchStudyObjectiveType#primary)

objective

name: Absolute change in SALT score from baseline at the end of 24 weeks' treatment period. [ Time Frame: 24 weeks treatment ]

type: Secondary (ResearchStudyObjectiveType#secondary)

objective

name: Proportion of the responders, i.e. subjects achieving at least a 40% relative reduction in SALT score from baseline at the end of 24 weeks' treatment period. [ Time Frame: 24 weeks treatment ]

type: Secondary (ResearchStudyObjectiveType#secondary)

objective

name: Adverse events [ Time Frame: 48 weeks ]

type: Secondary (ResearchStudyObjectiveType#secondary)

objective

name: General physical examination findings, including irritation of eyes and skin [ Time Frame: 24 weeks treatment ]

type: Secondary (ResearchStudyObjectiveType#secondary)

objective

name: Visual assessment and global standardised scalp photographs for SALT evaluation. [ Time Frame: After 12 and 24 weeks treatment ]

type: Secondary (ResearchStudyObjectiveType#secondary)

objective

name: Evaluation of duration of treatment effect in responders, measured as relative SALT score changes from Visit 3 (end of treatment) after 12 weeks (Visit 4) and 24 weeks (Visit 5) of treatment-free period. (Visual assessment and global standardised scalp photographs for SALT evaluation.)

type: Secondary (ResearchStudyObjectiveType#secondary)

objective

name: Assessment of treatment effect on hair follicles in non-alopecic areas by quantifying the number of new alopecic areas. [ Time Frame: 24 weeks treatment ]

type: Secondary (ResearchStudyObjectiveType#secondary)

objective

name: Assessment of the rate of spontaneous hair regrowth. [ Time Frame: For 6-12 months ]

type: Secondary (ResearchStudyObjectiveType#secondary)

objective

name: Assessment of the rate of spontaneous hair regrowth in placebo treated subjects with alopecia areata active for 6-12 months compared to those with alopecia areata active for more than 12 months. (Visual assessment and global standardised scalp photographs for SALT evaluation).

type: Secondary (ResearchStudyObjectiveType#secondary)

objective

name: Absolute and relative change from baseline in Children's Dermatology Life Quality Index (CDLQI) scores. [ Time Frame: 48 weeks ]

type: Secondary (ResearchStudyObjectiveType#secondary)

objective

name: Change in percentage of subjects from baseline by the severity banding CDLQI scores. [ Time Frame: 48 weeks ]

type: Secondary (ResearchStudyObjectiveType#secondary)

objective

name: Percentages of subjects by EuroQol Five Dimensions Youth Questionnaire (EQ-5D-Y) dimensions and levels at Visits 1-5. [ Time Frame: 48 weeks ]

type: Secondary (ResearchStudyObjectiveType#secondary)

objective

name: Absolute and relative change of the EQ-Visual Analogue Scale (EQ-VAS) scores from baseline [ Time Frame: 48 weeks ]

type: Secondary (ResearchStudyObjectiveType#secondary)

objective

name: Evaluation of the Paediatric Alopecia Areata Patient Benefit Index (PAAPBI) scores at Visits 1 to 5. [ Time Frame: 48 weeks ]

type: Secondary (ResearchStudyObjectiveType#secondary)