Efficacy and Safety of LH-8 in Paediatric Alopecia Areata

NCT03240627 | Completed Phase 2 DMC

• 1 other identifier: RAAINBOW
• Study Type: interventional
• Target: 107
• Locations: 3 countries
• Sites: 3

Brief Summary

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 France, Germany, Bulgaria and India in 100 patients.

Conditions

Alopecia Areata; Pediatric Disorder

Outcome Measures

Primary Outcomes (1)

• Relative change in scalp alopecia areata severity scores (SALT) from baseline value to be assessed after 24 weeks of treatment.

  Visual assessment and global standardised scalp photographs for SALT evaluation.

  24 weeks treatment

Secondary Outcomes (12)

• Absolute change in SALT score from baseline at the end of 24 weeks' treatment period.

  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.

  24 weeks treatment

• Adverse events

  48 weeks

• General physical examination findings, including irritation of eyes and skin

  24 weeks treatment

• Visual assessment and global standardised scalp photographs for SALT evaluation.

  After 12 and 24 weeks treatment

Study Arms (2)

LH-8 cutaneous solution

EXPERIMENTAL

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

Drug: LH-8

Placebo cutaneous solution

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

LH-8 DRUG

LH-8 cutaneous solution

LH-8 cutaneous solution

Placebo DRUG

Placebo cutaneous solution

Placebo cutaneous solution

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male and female children and adolescents aged 2 to less than 18 years.
• Active scalp alopecia areata, involving 25% to 95% of the scalp (as measured by SALT score at screening).
• Duration of hair loss between 6 months and 3 years.
• Female subjects of childbearing potential (postmenarcheal) must have a negative urine pregnancy test at screening. Females of childbearing potential must either not be sexually active or be using an adequate birth control method throughout the duration of the study.
• All subjects taking thyroid medication or hormonal therapy must be on a stable dose for 6 months and maintain such throughout the study.
• Subjects must be willing to maintain the same hair style, including hair dye, throughout the study period.
• Written informed consent signed by parent(s) or legally authorized representative and assent or consent signed by the subjects, if applicable, according to national regulations prior to any protocol specific procedures.

You may not qualify if:

• Hypersensitivity or intolerance to any active IMP substances (onion, citrus, caffeine, theobromine) or excipients (glycerine, betaine or ethanol).
• Any cause of hair loss other than alopecia areata.
• Active scalp inflammation except alopecia areata.
• Nevi, cutaneous or non-cutaneous lesions currently undiagnosed but suspicious for malignancy.
• Female adolescents who are pregnant or who are nursing or plan pregnancy during the trial period.
• Use of topical medication (listed in protocol Section 10.7.1) within 2 weeks prior to Visit 1.
• Use of systemic alopecia areata therapies (e.g. prednisone, cyclosporine, methotrexate), including use of these medications for other indications, and intralesional corticosteroids within 1 month prior to Visit 1.
• Administration of hydroxychloroquine or finasteride within two months prior to Visit 1.
• Use of phototherapy, laser therapy or excimer laser therapy on the scalp within three months prior to Visit 1.
• Use of infliximab within two months, adalimumab within three months, and ustekinumab within four months prior to Visit 1 or use of other TNF inhibitors and biologic agents within one month or five half-lives before Visit 1, whichever is longer.
• Prior treatment with IMP.
• Evidence or history of alcohol, medication or drug abuse.
• History of systemic or cutaneous medical, or psychiatric disease which will put subject at risk or interfere with assessments.
• Participation in any other clinical trial within 30 days prior to Visit 1.
• Subject is in a dependent relationship (e.g. relative or family member) with the investigator's or sponsor's staff.

Sponsors & Collaborators

• Legacy Healthcare SA: lead

Study Sites (3)

Multicenter Clinical Trials

Sofia, Bulgaria

Location

Centre Sabourand - Hospital Saint-Louis, 1, Avenue Claude Vellefaux

Paris, 75010, France

Location

Clinical Research Center for Hair and Skin Science, Charité-Universitätsmedizin Berlin

Berlin, State of Berlin, 10117, Germany

Location

Related Publications (1)

• Blume-Peytavi U, Piraccini BM, Reygagne P, Guiraud J, Mukherjee B, Guichard A, Liu J, Pralong W, Harti S. Efficacy and safety of Cinainu in paediatric alopecia areata: an international, double-blind, randomized, placebo-controlled, phase II/III trial. Br J Dermatol. 2026 Jan 6;194(1):37-46. doi: 10.1093/bjd/ljaf279.

  PMID: 40668972 DERIVED

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ulrike BLUME-PEYTAVI, Prof. Dr.

  Charité-Universitätsmedizin Berlin, Dept Dermatology, Germany

  STUDY CHAIR

• Pascal REYGAGNE, Dr.

  Sabouraud Center, Saint-Louis Hospital, France

  PRINCIPAL INVESTIGATOR

• Petyo Brezoev, Dr.

  DDC Alexandrovska-Sofia", Bulgaria

  PRINCIPAL INVESTIGATOR

• Uwe Schwichtenberg, Dr.

  Hautarztpraxis, Bremen-Vegesack, Germany

  STUDY DIRECTOR

• Maya Milanova, Dr

  Center of Skin and venereal diseases, Sliven, Bulgaria

  STUDY DIRECTOR

• Mariyana Venelinova_Rusinova, Dr

  MC Doverie, Sofia, Bulgaria

  STUDY DIRECTOR

• Ishad Aggarwal, Dr

  Health Point Hospital 21, Kolkata, India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomised, double-blind, vehicle-controlled multicentre trial in parallel groups.

Study Record Dates

• First Submitted: July 26, 2017
• First Posted: August 7, 2017
• Study Start: February 1, 2018
• Primary Completion: March 14, 2022
• Study Completion: September 14, 2022
• Last Updated: December 12, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); DE (1); BU (1)