DPCP Alopecia Areata Treatment Gets Phase III Clinical Trial
American researchers from the University of Minnesota, in conjunction with the US's National Alopecia Areata Foundation (NAAF), have registered a phase III clinical trial for a new type of topical immunotherapy in cases of extensive Alopecia Areata.
Diphenylcyclopropenone (DPCP), used in ointment form, will be used to treat 10 participants aged 18 and over, with 76%-99% hair loss of the scalp medically diagnosed to have been caused by this autoimmune disorder. The first part of the trial will be used to establish which strength(s) of the formulation is best to administer and investigate.
This follows the August 2018 findings of a systematic review into the efficacy of topical immunotherapy for all forms of autoimmune alopecia, uncovered by the Institute of Hair and Cosmetic Medicine at Yonsei University Wonju College of Medicine in Korea.
In order to assess the safety profile of DPCP as well as how effective the treatment may be, researchers will conduct trials using the following methodology, according to data found in the trial registration at clinicaltrials.gov:
'All subjects will be administered a sensitization dose of 0.05 mL 0.4% DPCP ointment formulation topically in the inner aspect of the upper right arm at Day -16, and 0.05 mL of four concentrations (0.1, .05, 0.01, 0.005%), prepared through dilutions in the ointment vehicle, topically on the inner aspect of the left thigh at Day -2.
The weakest strength that may cause a minimal reaction (DTH skin reaction score of 1+) after two days will be chosen, and 0.75-1 g of that concentration will be applied to the scalp starting at Week 1 and administered subsequently twice a week for 18 weeks.'
The study is not yet recruiting but hopes to start on 1st September 2018, with the final completion date currently estimated as 1st December 2019. This means a window of at least one-to-two years before the first JAK inhibitor treatments for Alopecia Areata - including its most severe phenotypes, Alopecia Totalis and Alopecia Universalis which cause baldness of the head and from head-to-toe, respectively - are estimated to become available for prescription.
At present, there are various Alopecia Areata treatment options for the scalp-only form, though the versions which affect other hair-bearing areas of the body have fewer choices. These range from various forms of topical immunotherapy to steroid treatments, though none have particularly significant success rates as yet.
Whilst hair regrowth tends to occur naturally within 12 months when it comes to the mildest form, this is not always the case and it is also less likely with the other, more extensive, forms.
Children under 16 years of age with any form of autoimmune-related hairloss, and adults with the more extreme phenotypes, should speak to their GP or dermatologist for advice on their options. They may also find specialist hair loss charities, such as Alopecia UK, useful for both information and peer support.
Diphenylcyclopropenone (DPCP), used in ointment form, will be used to treat 10 participants aged 18 and over, with 76%-99% hair loss of the scalp medically diagnosed to have been caused by this autoimmune disorder. The first part of the trial will be used to establish which strength(s) of the formulation is best to administer and investigate.
This follows the August 2018 findings of a systematic review into the efficacy of topical immunotherapy for all forms of autoimmune alopecia, uncovered by the Institute of Hair and Cosmetic Medicine at Yonsei University Wonju College of Medicine in Korea.
Testing the safety and efficacy of DPCP alopecia treatment
In order to assess the safety profile of DPCP as well as how effective the treatment may be, researchers will conduct trials using the following methodology, according to data found in the trial registration at clinicaltrials.gov:
'All subjects will be administered a sensitization dose of 0.05 mL 0.4% DPCP ointment formulation topically in the inner aspect of the upper right arm at Day -16, and 0.05 mL of four concentrations (0.1, .05, 0.01, 0.005%), prepared through dilutions in the ointment vehicle, topically on the inner aspect of the left thigh at Day -2.
The weakest strength that may cause a minimal reaction (DTH skin reaction score of 1+) after two days will be chosen, and 0.75-1 g of that concentration will be applied to the scalp starting at Week 1 and administered subsequently twice a week for 18 weeks.'
The study is not yet recruiting but hopes to start on 1st September 2018, with the final completion date currently estimated as 1st December 2019. This means a window of at least one-to-two years before the first JAK inhibitor treatments for Alopecia Areata - including its most severe phenotypes, Alopecia Totalis and Alopecia Universalis which cause baldness of the head and from head-to-toe, respectively - are estimated to become available for prescription.
Treating Alopecia Areata
At present, there are various Alopecia Areata treatment options for the scalp-only form, though the versions which affect other hair-bearing areas of the body have fewer choices. These range from various forms of topical immunotherapy to steroid treatments, though none have particularly significant success rates as yet.
Whilst hair regrowth tends to occur naturally within 12 months when it comes to the mildest form, this is not always the case and it is also less likely with the other, more extensive, forms.
Children under 16 years of age with any form of autoimmune-related hairloss, and adults with the more extreme phenotypes, should speak to their GP or dermatologist for advice on their options. They may also find specialist hair loss charities, such as Alopecia UK, useful for both information and peer support.
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