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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Female Pattern Baldness
• Intervention / Treatment: Drug: OMA102; Drug: OMA102; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 504
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Cassiano Ricardo O Berto, B.S.; Phone Number: +551938877724; Email: pesquisa.clinica@ncfarma.com.br

Study Locations

• Brazil
  • São Paulo
    • Hortolândia, São Paulo, Brazil
      • EMS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OMA102 1 mg; Ingestion of 1 oral tablet, once a day, immediately before lying down to sleep	Drug: OMA102; 1 mg; Drug: OMA102; 2 mg
Experimental: OMA102 2 mg; Ingestion of 1 oral tablet, once a day, immediately before lying down to sleep	Drug: OMA102; 1 mg; Drug: OMA102; 2 mg
Placebo Comparator: Placebo; Ingestion of 1 oral tablet, once a day, immediately before lying down to sleep	Drug: Placebo; OMA102 - Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of OMA102 1 mg and OMA102 2 mg in the promotion of hair growth in the mid front area assessed by digital phototrichogram.	Variation of hair in the mid-front area after 6 months of treatment in comparison to baseline, assessed by digital phototrichogram.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of OMA102 1 mg and OMA102 2 mg in the promotion of hair growth in the mid front area assessed by digital phototrichogram.	Variation of hair in the mid-front area after 3 months of treatment in comparison to baseline, assessed by digital phototrichogram.	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.	Variation of non vellus and vellus hair in the mid-front area after 3 and 6 months of treatment in comparison to baseline, assessed by digital phototrichogram.	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.	Efficacy of OMA102 1 mg and OMA102 2 mg in the proportion of subjects with an improvement global photographs assessed by Clinical Global Impression of Improvement (CGI-I) by the investigator perception, 3 and 6 months after treatment.	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.	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 investigator perception, 3 and 6 months after treatment.	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).	Efficacy of OMA102 1 mg and OMA102 2 mg in quality of life, assessed by Women's Androgenetic Alopecia Quality of Life (WAA-QoL) in comparison to baseline, 3 and 6 months after treatment.	3 and 6 months

Collaborators and Investigators

• Sponsor: EMS

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: April 11, 2023
• First Submitted That Met QC Criteria: April 11, 2023
• First Posted (Actual): April 21, 2023

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia
• Other Study ID Numbers: OMA102-III-0123

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No