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Alopecia AreataPhase 2/3AANCT03240627

Efficacy and Safety of LH-8 in Paediatric Alopecia Areata

A Phase 2/3 study testing LH-8 in people with Alopecia Areata and Pediatric Disorder, run by Legacy Healthcare SA at 3 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 2 to 18 years
Conditions the study is for
Alopecia Areata, Pediatric Disorder
What is being tested?
LH-8
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
107 participants
Where
3 sitesin 3 countries
Study dates
1 Feb 2018to 14 Sep 2022
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 16Show fewer
  • 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.
  • Any other condition or circumstance that, in the opinion of the investigator, could compromise the subject's ability to comply with the study protocol.

Trial locations and contacts

3 sites in 3 countries.

3 sites in 3 countries

Bulgaria1 site

  • Multicenter Clinical Trials

    Sofia

Other trials in Bulgaria

France1 site

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

    Paris, 75010

Other trials in France

Germany1 site

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

    Berlin, State of Berlin, 10117

Other trials in Germany

About this study

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.

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.

Read the detailed description

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.

Being tested
LH-8, Placebo
Medical subject headings
Alopecia Areata

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LH-8Drug

    LH-8 cutaneous solution

  • PlaceboDrug

    Placebo cutaneous solution

Study groups in NCT03240627
Study groupRoleWhat they receive
LH-8 cutaneous solutionExperimentalLH-8 cutaneous solution (0.126 mL per spray) applied to the whole scalp:
Receives: Drug: LH-8
Placebo cutaneous solutionPlacebo comparatorPlacebo cutaneous solution (0.126 mL per spray) applied to the whole scalp:
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 24 weeks treatment

Secondary outcomes (12)

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

    Measured: 24 weeks treatment

  2. 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.

    Measured: 24 weeks treatment

  3. Adverse events

    Measured: 48 weeks

  4. General physical examination findings, including irritation of eyes and skin

    Measured: 24 weeks treatment

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

    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.)

    Measured: After 12 and 24 weeks treatment

  6. Assessment of treatment effect on hair follicles in non-alopecic areas by quantifying the number of new alopecic areas.

    Measured: 24 weeks treatment

  7. Assessment of the rate of spontaneous hair regrowth.

    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).

    Measured: For 6-12 months

  8. • Absolute and relative change from baseline in Children's Dermatology Life Quality Index (CDLQI) scores.

    Measured: 48 weeks

  9. Change in percentage of subjects from baseline by the severity banding CDLQI scores.

    Measured: 48 weeks

  10. Percentages of subjects by EuroQol Five Dimensions Youth Questionnaire (EQ-5D-Y) dimensions and levels at Visits 1-5.

    Measured: 48 weeks

  11. Absolute and relative change of the EQ-Visual Analogue Scale (EQ-VAS) scores from baseline

    Measured: 48 weeks

  12. Evaluation of the Paediatric Alopecia Areata Patient Benefit Index (PAAPBI) scores at Visits 1 to 5.

    Measured: 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2017
  2. Study start1 Feb 2018
  3. Primary completion14 Mar 2022
  4. Study completion14 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomised, double-blind, vehicle-controlled multicentre trial in parallel groups.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
107 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03240627
Sponsor's protocol ID
RAAINBOW
Acronym
AA
Status last verified
Jun 2023
First submitted
26 Jul 2017
Last updated
12 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40668972

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing LH-8 in people with Alopecia Areata and Pediatric Disorder, run by Legacy Healthcare SA at 3 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Bulgaria, France, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03240627, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023.

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