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 : February 21, 2021
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 , Romania and France 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.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 :||April 1, 2021|
|Estimated Study Completion Date :||October 1, 2021|
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.
- Absolute change in SALT score from baseline at the end of 24 weeks' treatment period. [ Time Frame: 24 weeks treatment ]
- 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 ]
- Adverse events [ Time Frame: 48 weeks ]
- General physical examination findings, including irritation of eyes and skin [ Time Frame: 24 weeks treatment ]
- Visual assessment and global standardised scalp photographs for SALT evaluation. [ Time Frame: After 12 and 24 weeks treatment ]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.)
- Assessment of treatment effect on hair follicles in non-alopecic areas by quantifying the number of new alopecic areas. [ Time Frame: 24 weeks treatment ]
- Assessment of the rate of spontaneous hair regrowth. [ Time Frame: For 6-12 months ]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).
- • 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 1-5. [ 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03240627
|Contact: Alexandre GUICHARD, PharmD||+ 41 789 344 firstname.lastname@example.org|
|Contact: Nadine VINCENT, PharmD||+ 33 6 08 55 04 email@example.com|
|Centre Sabourand - Hospital Saint-Louis, 1, Avenue Claude Vellefaux||Recruiting|
|Paris, France, 75010|
|Contact: Pascal Reygagne, MD +33(0)142493937 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|
|Study Chair:||Ulrike BLUME-PEYTAVI, Prof. Dr.||Charité-Universitätsmedizin Berlin, Dept Dermatology, Germany|
|Principal Investigator:||Pascal REYGAGNE, Dr.||Sabouraud Center, Saint-Louis Hospital, France|
|Principal Investigator:||Yvan Botev, Dr.||"Diagnostic-consulting center XXIV-Sofia", Bulgaria|
|Principal Investigator:||Horia Beti, Dr.||SC Centrul Medical Sana SRL, Romania|