Comparison of Outcomes Between Topical Minoxidil Versus Oral Minoxidil for the Treatment of Androgenetic Alopecia (mina)

Sheikh Zayed Federal Postgraduate Medical Institute

Status and phase: Not yet enrolling; Phase 3

Conditions: Androgenic Alopecia

Treatments: Drug: Placebo Spray; Drug: minoxidil; Drug: Placebo Tablet or Capsule; Drug: Minoxidil 5 % Topical Spray

Study type: Interventional

Funder types: Other

Identifiers

NCT07273799

02-TERC/NHRC-SZH/Int-SC/651

Details and patient eligibility

About

To compare the outcome of topical minoxidil 5% spray versus oral minoxidil 2.5 mg tablet for the treatment of androgenetic alopecia in males and females. Outcomes include efficacy of the treatment, measured by reduction in hair shedding, improvement in hair density and new hair growth as assessed by physican and patient assessment as well as safety, defined as incidence and severity of adverse events over a treatment period of 6 months

Full description

This cohort, adaptive, randomized, double armed group, controlled, investigator-initiated interventional study is designed to demonstrate the superiority of a combination of Topical minoxidil vs oral minoxidil in patients suffering from androgenetic alopecia who consent to randomization following a new diagnosis in Pakistan.

Conditions Androgenetic Alopecia

Intervention/Treatment:

Drug: Oral Minoxidil Drug: Topical Minoxidil

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with androgenic alopecia Norwood-Hamilton class 2-6 in males and Sinclair class 2-5 in females
• History of androgentic alopecia for at least 1 year
• 18 to 50 years of age
• Willing to provide informed consent
• Willing to not use any other hair loss treatment during the treatment period

Exclusion criteria

• History of cardiovascular disease
• Use of some other hair restoration therapy in the past 6 months such as minoxidil, finasteride or PRP
• Presence of other causes of alopecia (e.g., alopecia areata, scarring alopecia).
• Pregnant and lactating females
• Previous Hair Transplantation
• Patients with a known hypersensitivity to the study drug or class of study drug
• Patients with co-morbid conditions like chronic liver disease, chronic kidney disease, neurological or psychiatric disorders
• Presence of any other autoimmune disease (especially thyroid disease)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 4 patient groups, including a placebo group

Disease Control

Placebo Comparator group

Description:

Placebo spray and palcebo tablet

Treatment:

Drug: Placebo Tablet or Capsule

Drug: Placebo Spray

Minoxidil Spray Arm

Active Comparator group

Description:

Placebo tablet Mixidil spray

Treatment:

Drug: Minoxidil 5 % Topical Spray

Drug: Placebo Tablet or Capsule

Minoxidil Tablet Arm

Active Comparator group

Description:

Mixidil tablet placebo spray

Treatment:

Drug: Placebo Spray

Drug: minoxidil

Minoxidil Tablet + Spray Arm

Experimental group

Description:

Minoxidil spray Minoxidil Tablet

Treatment:

Drug: Minoxidil 5 % Topical Spray

Drug: minoxidil