Androgenetic Alopecia Clinical Trial
Official title:
Minoxidil Dose Response Study in Females Identified Through IVD Testing as Non-Responders to 5% Topical Minoxidil
5% topical minoxidil is the maximum dosage approved by the US FDA for the treatment of
female pattern hair loss. While topical minoxidil exhibits a good safety profile, the
efficacy in the overall population is relatively low i.e., 30-40% re-grow hair.
The primary purpose of this study is to assess if a higher dosage of topical minoxidil
dosage (15%) will increase the number of responders among female subjects that have been
identified through IVD testing as non-responders to 5% topical minoxidil.
Approximately, 40% of women suffer from female pattern hair loss by the age of 55.
Currently, there is only one drug approved by the US FDA for the treatment of female pattern
hair loss (AGA) - topical minoxidil.
5% topical minoxidil is the maximum dosage approved by the US FDA for the treatment of
female AGA. While topical minoxidil exhibits a good safety profile, the efficacy in the
overall population is relatively low i.e., 30-40% re-grow hair.
Minoxidil is a pro-drug. To elicit a clinical response, minoxidil must be converted to its
active form minoxidil sulfate by a sulfotransferase enzyme found in hair follicles. The
investigators have developed an in-vitro diagnostic test that correctly identifies, prior to
initiating therapy, 95.9% of non-responders to 5% topical minoxidil. The diagnostic test
analyzes the sulfotransferase enzymatic activity in hair follicles to determine if a
sufficient amount of minoxidil will be converted to the active form required to induce hair
growth. Subjects with low enzymatic activity experience little or no therapeutic benefit and
a reduced frequency of adverse events.
Consequently, the investigators hypothesize that in subjects with low enzymatic activity
(i.e., low minoxidil metabolizers) an increased minoxidil dosage will elicit a therapeutic
response with little or no increase in the frequency of adverse events. It is thus the
primary purpose of this study to assess if a higher dosage of topical minoxidil dosage (15%)
will increase the number of responders among female subjects that have been identified
through IVD testing as non-responders to 5% topical minoxidil.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02591355 -
Evaluate the Clinical Effectiveness of RegenKit Platelet-rich Plasma (PRP) in Androgenetic Alopecia Treatment
|
N/A | |
Withdrawn |
NCT03852992 -
Laser Assisted Delivery of Minoxidil in Androgenetic Alopecia
|
Phase 2 | |
Recruiting |
NCT06239207 -
Efficacy and Safety of Exosomes Versus Platelet Rich Plasma in Patients of Androgenetic Alopecia
|
Phase 2 | |
Completed |
NCT04945226 -
A Clinical Trial to Assess Pharmacokinetic/Pharmacodynamic Profiles and Safety of IVL3001
|
Phase 1/Phase 2 | |
Completed |
NCT01548066 -
The Efficacy and Safety of Topical Valproic Acid in Preventing Hair Loss
|
Phase 2 | |
Completed |
NCT01437163 -
Treatment of Androgenetic Alopecia in Males and Females
|
N/A | |
Completed |
NCT01226459 -
Clinical Trial in Females for Female Pattern Hair Loss
|
Phase 3 | |
Recruiting |
NCT06118866 -
A Study to Assess the Efficacy and Safety of HMI-115 in Male Subjects With Androgenetic Alopecia
|
Phase 2 | |
Completed |
NCT06149221 -
Penetration-enhanced Direct DBD Non-thermal Plasma for Hair Loss
|
N/A | |
Withdrawn |
NCT04882969 -
Thulium Laser and KeraFactor for the Treatment of Androgenetic Alopecia
|
N/A | |
Completed |
NCT01231607 -
Dutasteride Versus Placebo and Finasteride in Men With Androgenetic Alopecia
|
Phase 3 | |
Completed |
NCT04446429 -
Anti-Androgen Treatment for COVID-19
|
N/A | |
Completed |
NCT02729415 -
Point-of-Care Adipose-derived Cells for Hair Growth
|
N/A | |
Completed |
NCT02279823 -
A Phase 2 Study to Evaluate the Safety and Efficacy of CB-03-01 Solution, a Comparator Solution and Vehicle Solution in Males With Androgenetic Alopecia
|
Phase 2 | |
Not yet recruiting |
NCT01227031 -
Pharmacogenomic Study of Androgenetic Alopecia
|
N/A | |
Completed |
NCT00981461 -
Treatment of Androgenetic Alopecia in Females, 9 Beam
|
N/A | |
Completed |
NCT01451021 -
A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss
|
Phase 2 | |
Completed |
NCT00151515 -
A Study to Evaluate the Effectiveness and Safety of 5 Percent Minoxidil Foam in the Treatment of Male Pattern Hair Loss
|
Phase 3 | |
Completed |
NCT03694067 -
Androgenetic Alopecia and the JAK-STAT Pathway
|
||
Completed |
NCT03689452 -
The Effect of Platelet Rich Plasma on Non-scarring Alopecia
|
N/A |