Delgocitinib Cream for Hair Loss
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test whether a cream called delgocitinib can safely and effectively treat frontal fibrosing alopecia, a type of hair loss affecting the front of the scalp. Participants will apply the cream to affected areas to determine its impact on symptoms like redness and scaling around hair follicles. The trial seeks adults with a confirmed diagnosis of this condition who experience moderate to severe symptoms. Participants should maintain consistent hair care routines and avoid certain treatments or products during the trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Is there any evidence suggesting that delgocitinib cream is likely to be safe for humans?
Research has shown that delgocitinib cream is generally safe and well-tolerated for use over 24 weeks. Studies have found that patients often experienced hair regrowth and their condition stabilized while using the cream. Some side effects occurred, but these were usually mild, meaning they were not serious or harmful. Importantly, other studies found that the cream does not spread much beyond the application area, suggesting it is safe to use. Overall, the evidence indicates that delgocitinib cream is safe for treating hair loss.12345
Why do researchers think this study treatment might be promising for hair loss?
Unlike traditional hair loss treatments that often involve oral medications or topical solutions like minoxidil and finasteride, Delgocitinib cream offers a novel approach by targeting the body's immune response. This cream is a JAK inhibitor, which means it works by blocking specific enzymes that play a role in inflammation and immune system activity. Researchers are excited about Delgocitinib because it has the potential to address an underlying cause of hair loss rather than just the symptoms, providing a more targeted treatment option. Additionally, as a topical cream, it may offer a convenient and potentially less systemic side effect profile compared to oral medications.
What evidence suggests that delgocitinib cream might be an effective treatment for hair loss?
Research has shown that delgocitinib cream can help with hair loss. One study found that people using the cream experienced some hair regrowth and their condition stabilized after 24 weeks. Another study revealed that after 16 weeks, those using the cream had better results than those using a placebo. Delgocitinib also reduced inflammation, which is thought to contribute to certain types of hair loss, such as frontal fibrosing alopecia. Specifically, people treated with delgocitinib grew more hair compared to those who didn't use the cream. Overall, these findings suggest that delgocitinib cream could be a promising treatment for hair loss.13567
Are You a Good Fit for This Trial?
This trial is for adults diagnosed with frontal fibrosing alopecia (a type of hair loss affecting the front of the scalp). Participants should generally be in good health. People with other major skin conditions or who are pregnant or breastfeeding may not be eligible.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive delgocitinib 20 mg/g cream for 24 weeks to assess safety and effectiveness
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Delgocitinib
Trial Overview
The study is testing a cream called delgocitinib (20 mg/g) to see if it is safe and effective for treating frontal fibrosing alopecia. All participants will use this investigational cream as part of an open-label Phase II trial.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Maryanne Makredes Senna
Lead Sponsor
Citations
A case of refractory alopecia areata successfully treated by ...
0.5% delgocitinib ointment in combination with EL led to complete hair regrowth beginning 2 months later, with complete remission achieved ...
Delgocitinib 20 mg/g cream for the treatment of lichen ...
By 2 months, she demonstrated marked improvement in hair density, with near-complete regrowth observed at 4 months of treatment with twice-daily delgocitinib ...
Randomized Controlled Trial of the Topical Jak Inhibitor ...
At 24 weeks, all patients achieved some degree of hair regrowth and stabilization of disease. Delgocitinib cream was well-tolerated.
Delgocitinib Cream for Hair Loss · Info for Participants
Specifically, one study demonstrated its greater effectiveness compared to a placebo cream, with improved results over 16 weeks. Overall, delgocitinib cream ...
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clinicaltrials.gov
clinicaltrials.gov/study/NCT07671157?locStr\u003dUnited+States\u0026country\u003dUnited+StatesPhase 2 Open Label Trial of Delgocitinib 20 mg/g Cream ...
Phase II clinical trials test the safety and effectiveness of an investigational study drug to learn whether the delgocitinib 20 mg/g cream works in treating a ...
Randomized Controlled Trial of the Topical JAK Inhibitor ...
Delgocitinib cream resulted in an improvement in the transcriptomic profile of lesions and may have potential as a topical treatment for FFA.
Safety and Biomarker Responses of Delgocitinib (JAK1,2,3 ...
This study evaluates the safety, tolerability, and biomarker effects of twice-daily topical delgocitinib 2% cream in adults with lichen planopilaris (LPP)
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