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Not yet recruiting NCT05824065

Efficacy and Safety of OMA102 in the Treatment of Female Pattern Hair Loss

Phase III Interventional Female Pattern Baldness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: OMA102, OMA102, Placebo.
Who it may be relevant to
Registry conditions: Female Pattern Baldness. Basic parameters: 18 years — 50 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Phase III, National, Multicenter, Randomized, Double-Blind, Superiority Clinical Trial to Evaluate the Efficacy and Safety of OMA102 in the Treatment of Female Pattern Hair Loss

Overview

The goal of this clinical trial is to evaluate the efficacy and safety of OMA102 1 mg and OMA102 2 mg versus placebo in the treatment of female pattern hair loss.

Interventions

  • Drug OMA102
    1 mg
  • Drug OMA102
    2 mg
  • Drug Placebo
    OMA102 - Placebo

Primary outcome measures

  • Efficacy of OMA102 1 mg and OMA102 2 mg in the promotion of hair growth in the mid front area assessed by digital phototrichogram. [Time frame: 6 months]
Secondary outcome measures (5)
  • Efficacy of OMA102 1 mg and OMA102 2 mg in the promotion of hair growth in the mid front area assessed by digital phototrichogram. [Time frame: 3 months]
  • Efficacy of OMA102 1 mg and OMA102 2 mg in the promotion of non vellus and vellus hair growth, in the mid frontal area, assessed by digital phototrichogram. [Time frame: 3 and 6 months]
  • Efficacy of OMA102 1 mg and OMA102 2 mg in the proportion of subjects with an improvement of global photographs, assessed by Clinical Global Impression of Improvement (CGI-I) by the investigator perception. [Time frame: 3 and 6 months]
  • Efficacy of OMA102 1 mg and OMA102 2 mg in the proportion of subjects with an improvement of global photographs, assessed by Patient Global Impression, PGI-I, by the subject perception. [Time frame: 3 and 6 months]
  • Efficacy of OMA102 1 mg and OMA102 2 mg in quality of life, assessed by Women's Androgenetic Alopecia Quality of Life (WAA-QoL). [Time frame: 3 and 6 months]

Eligibility criteria

Inclusion criteria

  • Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
  • Age greater than 18 and equal or under 50 years;
  • Confirmed diagnosis of female pattern hair loss, grade II to IV in Sinclair Scale;
  • Participants that are disposed to maintain the same hair color, style, approximate hair length throughout the Clinical Study.

Exclusion criteria

  • Any clinical or physical finding interpreted by the investigator as a risk to subject participation in the Clinical Study
  • History of alcohol or illicit drugs abuse in the last year;
  • Pregnant or breastfeeding women, who are planning to become pregnant or participants who have childbearing potential and are not using any reliable contraceptive method;
  • Allergy or sensibility to any knowing components of the formula;
  • Diagnosis of arterial hypertension;
  • History of vasovagal syncope;
  • Baseline systolic blood pressure lower than 90 mmHg and/or diastolic lower than 60 mmHg;
  • Diagnosis of orthostatic hypotension (reduction of systolic blood pressure equal or superior to 20 mmHg and/or diastolic equal or superior to 10 mmHg after 3 minutes in orthostatic position);
  • Body mass index (BMI) > 30 kg/m²;
  • Subjects that initiated any kind of continue use medication, including contraceptives with systemic effect, until 3 months previously the inclusion in the Clinical Study;
  • History of cardiovascular, liver and renal diseases;
  • History of hypothyroidism, hyperthyroidism or pheochromocytoma;
  • Signs or symptoms of cardiopathy or angina;
  • History of edema from any etiology;
  • Participants who are using tricycle antidepressants, benzodiazepines, antipsychotics, anticholinergics, sulfonamide derivatives, beta-blockers, sympathomimetics, arginine, glucocorticoid or monoamine oxidase inhibitors;
  • Use of inhibitor of 5-alpha reductase or androgenic blockers in the last 12 months;
  • Dermatologic diseases of the scalp, except mild seborrheic dermatitis or diagnosis of any kind of alopecia other than female pattern hair loss;
  • History of surgical treatment for hair loss or presence of shaved scalp;
  • Scalp microinfusion, microneedling or intradermotherapy in the last 3 years;
  • Vaginal or cesarean deliveries 6 months before the inclusion in the study;
  • Drastic modification of habitual diet, as food restrictions or hyperselectivity;
  • Current cancer or history of cancer in the last 5 years;
  • Participation in others research protocols in the last 12 months, unless the investigator judges that there may be a direct benefit to the participant.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Brazil · 1 center
  • EMS — Hortolândia

Identifiers

NCT: NCT05824065 · OMA102-III-0123

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗