Update on LH-8 Children’s Alopecia Areata Treatment Trial
A clinical trial first registered in August 2017 is now recruiting and is aiming to treat autoimmune-related hair loss in children using a topical spray.
It is entitled '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' and has an estimated final completion date of December 2019.
Carried out by the Swiss company Legacy Healthcare in conjunction with the dermatology department of Germany's Charité-Universitätsmedizin Berlin, the trial is exploring the use of a topical substance known as LH-8.
Blue indicates the areas affected by each individual Alopecia Areata phenotype
According to the Phase 2 trial's registration information, the 100 participants - both male and female - will be aged between 2 and 17 years of age. They must have hair loss from Alopecia Areata that affects 25 per cent to 95 per cent of their scalp and has lasted between 6 months and 3 years.
Exclusion criteria includes under 18's with a 'Hypersensitivity or intolerance to any active IMP substances (onion, citrus, caffeine, theobromine) or excipients (glycerine, betaine or ethanol)'.
The trials will take place in Germany, Bulgaria and Romania and will involve the children being treated with solutions containing LH-8 or a placebo control in 0.126 mL doses per spray.
At present there are very few viable Alopecia Areata treatment options when it comes to paediatric cases. Though the scalp-only form can be treated in those aged 16 years and over, for children available treatments tend to be hospital-based and involve the use of topical or injected steroids.
The fact that Legacy researchers are not looking for completely bald children indicates that they are not including those with Alopecia Totalis or Alopecia Universalis. These are the most severe forms of Alopecia Areata and both cause total baldness of the head, with Universalis also causing the entire body to become hairless as well.
This area is currently under-served for both children and adults as there are no compelling, safe and effective treatments for Alopecia Totalis or Universalis at present. It is for this reason that the Food and Drug Administration (FDA) - the American equivalent to the UK's MHRA - has fast-tracked the clinical testing of a new drug believed to have the potential to treat all forms of autoimmune alopecia. The medication is named CTP-543 and trials are said to be progressing well, though it could still be a number of years before it comes to market - and even then, only if it meets the necessary safety and tolerability criteria. This novel drug is thought to only be being tested on adult participants for now.
Often brought on by triggers such as sudden shock, trauma or allergies, the scalp-only form of Alopecia Areata can be tricky to test treatments on given in many cases the hair will regrow naturally within 12 months. However, if or when this hair regrowth may occur - or if the condition may recur at a later date, as it is wont to do - cannot be predicted.
Hairloss can be worrying at any age, but for children losing their hair can be particularly traumatic. Presently, in lieu of substantive solutions, one of the most popular coping mechanisms is to wear a wig.
Charities such as the Little Princess Trust and Hero by LPT in the UK, and Locks for Love in the USA, provide real-hair wigs to children with medical hair loss. This typically means Alopecia Areata and baldness as a result of cancer treatment.
These organisations take donations of both hair and money in order to create the wigs which are then distributed free of charge to those in need.
It is entitled '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' and has an estimated final completion date of December 2019.
Carried out by the Swiss company Legacy Healthcare in conjunction with the dermatology department of Germany's Charité-Universitätsmedizin Berlin, the trial is exploring the use of a topical substance known as LH-8.
Paediatric Alopecia Areata
According to the Phase 2 trial's registration information, the 100 participants - both male and female - will be aged between 2 and 17 years of age. They must have hair loss from Alopecia Areata that affects 25 per cent to 95 per cent of their scalp and has lasted between 6 months and 3 years.
Exclusion criteria includes under 18's with a 'Hypersensitivity or intolerance to any active IMP substances (onion, citrus, caffeine, theobromine) or excipients (glycerine, betaine or ethanol)'.
The trials will take place in Germany, Bulgaria and Romania and will involve the children being treated with solutions containing LH-8 or a placebo control in 0.126 mL doses per spray.
At present there are very few viable Alopecia Areata treatment options when it comes to paediatric cases. Though the scalp-only form can be treated in those aged 16 years and over, for children available treatments tend to be hospital-based and involve the use of topical or injected steroids.
The fact that Legacy researchers are not looking for completely bald children indicates that they are not including those with Alopecia Totalis or Alopecia Universalis. These are the most severe forms of Alopecia Areata and both cause total baldness of the head, with Universalis also causing the entire body to become hairless as well.
This area is currently under-served for both children and adults as there are no compelling, safe and effective treatments for Alopecia Totalis or Universalis at present. It is for this reason that the Food and Drug Administration (FDA) - the American equivalent to the UK's MHRA - has fast-tracked the clinical testing of a new drug believed to have the potential to treat all forms of autoimmune alopecia. The medication is named CTP-543 and trials are said to be progressing well, though it could still be a number of years before it comes to market - and even then, only if it meets the necessary safety and tolerability criteria. This novel drug is thought to only be being tested on adult participants for now.
Often brought on by triggers such as sudden shock, trauma or allergies, the scalp-only form of Alopecia Areata can be tricky to test treatments on given in many cases the hair will regrow naturally within 12 months. However, if or when this hair regrowth may occur - or if the condition may recur at a later date, as it is wont to do - cannot be predicted.
Children's hair loss
Hairloss can be worrying at any age, but for children losing their hair can be particularly traumatic. Presently, in lieu of substantive solutions, one of the most popular coping mechanisms is to wear a wig.
Charities such as the Little Princess Trust and Hero by LPT in the UK, and Locks for Love in the USA, provide real-hair wigs to children with medical hair loss. This typically means Alopecia Areata and baldness as a result of cancer treatment.
These organisations take donations of both hair and money in order to create the wigs which are then distributed free of charge to those in need.
The Belgravia Centre
The Belgravia Centre is a world-renowned group of a hair loss clinic in Central London, UK. If you are worried about hair loss you can arrange a free consultation with a hair loss expert or complete our Online Consultation from anywhere in the world for home-use treatment.
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