This trial is evaluating whether CTP-543, 12 mg BID will improve 1 primary outcome and 16 secondary outcomes in patients with Alopecia. Measurement will happen over the course of Week 24.
This trial requires 517 total participants across 3 different treatment groups
This trial involves 3 different treatments. CTP-543, 12 Mg BID is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.
Alopecia can be cured in some individuals. Further studies are necessary that evaluate alopecia remission and improvement in other patients and those at high risk of developing and maintaining alopecia for long-term maintenance.
Estimates of the number of people affected by AA range from 1.3–15.5 million annually in the United States. The highest estimates are from the US. The magnitude of the estimates suggest that AA should probably receive heightened clinical and research attention.
Alopecia is a common problem for men, affects more than half of the population and can be associated with psychological distress. The most common form of alopecia seen in older men is a form called androgenetic alopecia. Androgenic hair loss can be treated with steroidal ornon steroidal hair products. The primary cause of androgenic hair loss in men is chronic androgen exposure due to low levels of testosterone in their blood. The most common form of hair loss seen in older men is the baldness seen with age. There is no effective treatment for the majority of hair loss. Men over the age of 65 are more likely to develop the condition.
There are not many common treatments for alopecia, and the use of the medications, 5-alpha-reductase inhibitors and androgen depletion for the treatment of this condition remains controversial. However, hair loss can be induced using topical corticosteroids, hair growth in androgenic azoospermia can be restored using the combination of topical ciclosporin and topical retinoids in the treatment of both male and female androgenic alopecia. There is a significant need for more information for the diagnosis and treatment of androgen-mediated male and female hair loss.
The cause of alopecia is not fully understood and it is in part due to the fact that it lacks a standard diagnostic tool. The main causes associated to Alopecia are: alopecia areata, lichen planus, frontal fibrosing alopecia, congenital disorders such as Wiskott-Aberstein syndrome, dyskeratosis congenita, trichilemmomas and immunodeficiency disorders. It is also important to assess the presence of other signs and symptoms, and whether they are indicative of a disorder.
Alopecia affects a patient's appearance, affects their self-esteem and makes them feel ashamed for their condition. The appearance of the patient with alopecia is a sign of hair loss and follicles are the main cause for hair loss.
Previous reports have suggested a genetic or heritable basis for at least some forms of congenital androgenic alopecia, and our study seems to further support this link. The use of a sensitive and reliable genetic method such as linkage analysis seems to be the appropriate next step in the elucidation of the cause of androgenic alopecia and its many associations in the population.
CTP-543 12 mg bid was not more effective than placebo in this study. In a recent study, findings were inconsistent, with most patients not achieving meaningful improvements in the scalp hair density parameter. Further development of CTP-543 12 mg bid for the treatment of CTP-543-induced HRT failure may prove worthwhile, and may represent a viable alternative to existing treatments for patients with chronic alopecia.
It would be difficult to determine which patients are eligible to be in clinical trials because, although the number of patients in a clinical trial may be small, and the study is unlikely to be large enough to confirm a statistical difference, enrollment of patients in the study is often based on a statistical likelihood of a difference between the groups being examined. While clinical trials may add important information to the current understanding of medicine, the results should be interpreted cautiously and used for only the most compelling indications. It is recommended that future clinical trials on alopecia should use appropriate measures for enrolling patients and be conducted on the basis of the strongest available evidence for a given therapeutic intervention.
It is likely that the age of onset is relatively delayed in men. We need to establish an earlier average age of onset for women.
CCP-543 is an effective treatment for women with CTLX, and the results were well tolerated with no significant changes to menstruation, or QTc interval, in clinical trials.
The side effects observed up to week 12 were usually mild and of minimal relevance, except for one woman who had slight vertigo and mild sweating. In addition to the side effects listed above, one patient complained of 'feeling as though the world was collapsing'. A majority of patients experienced some side effect. Therefore, it is important that side effects of ctp-543 are appropriately reported and evaluated by the patient and their physician following treatment with ctp-543.