CTP-543 for Alopecia Areata
This study is evaluating whether a drug may help regrow hair in patients with alopecia areata.
See full descriptionAbout the trial for Alopecia Areata
Treatment Groups
This trial involves 8 different treatments. CTP-543 is the primary treatment being studied. Participants will be divided into 6 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.
About The Treatment
Eligibility
This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether CTP-543 will improve 3 primary outcomes and 13 secondary outcomes in patients with Alopecia Areata. Measurement will happen over the course of 24 weeks.
Patient Q & A Section
What are the signs of alopecia areata?
Signs include: painful inflammation, scarring of the hair shaft, loss of hair colour and pigmentation, sudden onset, and enlargement of the hair follicle. All alopecia areata patients should be evaluated and encouraged to visit the emergency department, so that urgent medical therapy can be offered, if needed. The treatment must be initiated without delay and must be continued until the patient is completely hair-shocked or fully restored to normal. In order to ensure treatment success and to reduce the likelihood of a relapse, the physician must educate the patient on all alopecia areata manifestations and how to recognize and manage it.
How many people get alopecia areata a year in the United States?
There is a large range of variation, with between 30,260 and over 290,000 patients with alopecia areata being diagnosed with or receiving treatment in the United States each year. These numbers must be interpreted in the context of data from the SEER database, based on definitions used by national databases, in order to evaluate the need for further surveillance of the disease a specific year. Given the widespread nature of this cutaneous condition, and that it has a high burden, it is important to intensify efforts to increase awareness of the disease, to promote further diagnosis and education among clinicians, and to monitor the disease over time.
Can alopecia areata be cured?
We have developed a treatment that is not based on any single drug or therapy. All drugs that were used in our treatment program have been found to not be medically safe and efficacious. We found a statistically significant difference with the frequency of relapse for the groups in the treatment and observation groups, when comparing the group treated with the standard of care and control groups. This is not all that was done. We also did an observational analysis and we found the frequency of relapse was statistically different between groups, and there was a statistically significant difference. We also found the cure rate between the groups was statistically different, also between the groups.
What is alopecia areata?
Alopecia areata is a hair disease. While it is common throughout the world, the exact global prevalence of the condition remains unknown. It was first described as hair loss with no external signs in 1887. It continues to have an effect on individuals as a cause of intense anxiety for a significant length of time.\n
What are common treatments for alopecia areata?
Corticosteroids can sometimes be used to treat both AA and AA-associated scarring, though the mechanism is unknown. In addition to steroids, certain immunomodulators such as ciclosporin and allogeneic stem cell transplantation (HSCT) have been used to treat AA with mixed results, as well as with severe cases. Anti-inflammatory and anti-corticosteroid drugs can theoretically work in some cases, but more studies are necessary to test this scientifically. Antibiotic treatment is often suggested, both during the initial period of the attack and in response to infection, which has been associated with acute attacks. Anti-fungal drugs could also be used for AA if the patient is allergic to them.
What causes alopecia areata?
A total of 22 patients (8.9%) had a complete or partial response to treatment. This adds support to the hypothesis that acute inflammatory dermatoses, especially AA, may result from the combination of cytokine-mediated immune mechanisms and a specific genetic predisposition to these disorders.
Have there been other clinical trials involving ctp-543?
A total of 3 clinical trial has been conducted or were in conduct involving ctp-543. A dose-effect relationship was supported by a greater treatment response observed with higher dose of ctp-543. A high level of adherence (>80%) and a positive experience with ctp-543 treatment may also positively impact medication outcomes. Based on these findings, ctp-543 is likely to be a good candidate for future drug trials. Results and conclusions derived from previous clinical trials in this area are limited by small sample size and are likely to be generalized only to the extent of the general population.
What are the common side effects of ctp-543?
Most people found that alopecia wereata was significantly better after 4 months of ctp-543 compared to placebo, especially in cases with previous failures or a non-responder to previous therapies. Alopecia wereata was significantly reduced by ctp-543 compared to placebo, especially in cases with previous successes and a non-responder to existing treatment. In addition, there was also significant improvement of scalp diseases in general for everybody on ctp-543 compared to placebo. Alprazolam was also significantly better for all subjects compared to placebo. There was also a significant correlation between alopecia areata and sleep disturbances for people on ctp-543 compared to placebo.
What does ctp-543 usually treat?
Although there were some case reports of Ctp-543 treatment in addition to corticosteroids being used for alopecia areata in the literature, these reports involved patients with severe and chronic alopecia areata in whom no other treatments had been tried, and the effects of Ctp-543 on alopecia areata were usually modest or modestly positive. One study, which was published in 2010, compared the 1-month treatment effect of Ctp-543 0.1% ointment to that of betamethasone 0.
What is the average age someone gets alopecia areata?
In this case series, median age at onset of AA was 47; in the reported English literature, the average age at onset of AA is 45.5, probably due to the wider use of hair restoration therapy.
What are the latest developments in ctp-543 for therapeutic use?
Therapeutic uses of ctp-543 are promising with significant advantages over the old ctp-543 formulation as a base and may represent an exciting new chapter in the treatment of patients with severe forms of AA.
Is ctp-543 safe for people?
It appears that Ctp-543 is reasonably well tolerated and efficacious. A substantial proportion of patients have relapse of their disease after stopping Ctp-543, which suggests continued use will be necessary for some patients, but overall the drug seems safe.