Efficacy and Safety of LH-8 in Paediatric Alopecia Areata (AA)
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|ClinicalTrials.gov Identifier: NCT03240627|
Recruitment Status : Recruiting
First Posted : August 7, 2017
Last Update Posted : March 9, 2018
Double-blind, randomised, multi-centre study to evaluate the efficacy and safety of LH-8 cutaneous solution versus placebo in children and adolescents with moderate to severe scalp alopecia areata.
Phase 2/3 study performed in Germany, Bulgaria and Romania in 100 patients.
|Condition or disease||Intervention/treatment||Phase|
|Alopecia Areata Pediatric Disorder||Drug: LH-8 Drug: Placebos||Phase 2 Phase 3|
Methods / trial design:
Randomised, double-blind, vehicle-controlled multicentre trial in parallel groups.
At screening (Visit 0), subjects will discontinue their previous treatment for alopecia areata, if any. Screening period will last up to 28 days. The 24-week treatment phase will include assessment Visits 1 to 3, which will take place at 12-week intervals. At assessment Visit 1, eligible subjects will be randomly assigned in a 2:1 ratio to receive LH-8 cutaneous solution or vehicle (placebo) twice daily for a 24 week treatment period. During the treatment phase the subjects will complete daily their drug diaries. The post-treatment safety and efficacy follow-up phase will include Visit 4 and Visit 5, 12 and 24 weeks after end of treatment, respectively.
Subjects (as applicable) and parents will be instructed to contact the investigator, if an event on scalp (intolerance) occurs during the treatment or post-treatment period. They may be asked to come to the site for an unscheduled visit, in order to perform additional examinations.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomised, double-blind, vehicle-controlled multicentre trial in parallel groups.|
|Official 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.|
|Actual Study Start Date :||March 1, 2018|
|Estimated Primary Completion Date :||June 30, 2019|
|Estimated Study Completion Date :||December 30, 2019|
Experimental: LH-8 cutaneous solution
LH-8 cutaneous solution (0.126 mL per spray) applied to the whole scalp:
LH-8 cutaneous solution
Placebo Comparator: Placebo cutaneous solution
Placebo cutaneous solution (0.126 mL per spray) applied to the whole scalp:
Placebo cutaneous solution
- 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.
- 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 ]
- Absolute change in SALT score from baseline at the end of 24 weeks' treatment period. [ Time Frame: 24 weeks treatment ]
- Adverse events [ Time Frame: 48 weeks ]
- General physical examination findings, including irritation of eyes and skin [ Time Frame: 48 weeks ]
- Evaluation of duration of treatment effect in responders, measured as relative SALT score changes [ Time Frame: 48 weeks ]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.
- Assessment of treatment effect on hair follicles in non-alopecic areas [ Time Frame: 48 weeks ]By quantifying the number of new alopecic areas.
- Assessment of the rate of spontaneous hair regrowth in placebo treated subjects [ Time Frame: 48 weeks ]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)
- Absolute and relative change from baseline in Children's Dermatology Life Quality Index (CDLQI) scores [ Time Frame: 48 weeks ]
- Change in percentage of subjects from baseline by the severity banding CDLQI scores. [ Time Frame: 48 weeks ]
- Percentages of subjects by EuroQol Five Dimensions Youth Questionnaire (EQ-5D-Y) dimensions and levels at Visits 1 to 5 [ Time Frame: 48 weeks ]
- Absolute and relative change of the EQ-Visual Analogue Scale (EQ-VAS) scores from baseline [ Time Frame: 48 weeks ]
- Evaluation of the Paediatric Alopecia Areata Patient Benefit Index (PAAPBI) scores at Visits 1 to 5. [ Time Frame: 48 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03240627
|Contact: Marie Cristina SANDRU, PhD||:+ 49 724 512 email@example.com|
|Contact: Alexandre GUICHARD, PharmD.,PhD||+ 41 789 344 firstname.lastname@example.org|
|Clinical Research Center for Hair and Skin Science, Charité-Universitätsmedizin Berlin||Recruiting|
|Berlin, Berlin,, Germany, 10117|
|Contact: Ulrike KZ Blume-Peytavi, Prof. MD. ++49 30 450 518 122 Ulrike.email@example.com|
|Principal Investigator:||Ulrike BLUME-PEYTAVI, Prof. Dr.||Charité-Universitätsmedizin Berlin, Dept Dermatology, Germany|