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

Primary Purpose

Female Pattern Baldness

Status
Not yet recruiting
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
OMA102
OMA102
Placebo
Sponsored by
EMS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Female Pattern Baldness

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • EMS

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

OMA102 1 mg

OMA102 2 mg

Placebo

Arm Description

Ingestion of 1 oral tablet, once a day, immediately before lying down to sleep

Ingestion of 1 oral tablet, once a day, immediately before lying down to sleep

Ingestion of 1 oral tablet, once a day, immediately before lying down to sleep

Outcomes

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.
Variation of hair in the mid-front area after 6 months of treatment in comparison to baseline, assessed by digital phototrichogram.

Secondary 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.
Variation of hair in the mid-front area after 3 months of treatment in comparison to baseline, assessed by digital phototrichogram.
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.
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.
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.
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.

Full Information

First Posted
April 11, 2023
Last Updated
April 11, 2023
Sponsor
EMS
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1. Study Identification

Unique Protocol Identification Number
NCT05824065
Brief Title
Efficacy and Safety of OMA102 in the Treatment of Female Pattern Hair Loss
Acronym
GENERA
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Pattern Baldness

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
504 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OMA102 1 mg
Arm Type
Experimental
Arm Description
Ingestion of 1 oral tablet, once a day, immediately before lying down to sleep
Arm Title
OMA102 2 mg
Arm Type
Experimental
Arm Description
Ingestion of 1 oral tablet, once a day, immediately before lying down to sleep
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Ingestion of 1 oral tablet, once a day, immediately before lying down to sleep
Intervention Type
Drug
Intervention Name(s)
OMA102
Intervention Description
1 mg
Intervention Type
Drug
Intervention Name(s)
OMA102
Intervention Description
2 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
OMA102 - Placebo
Primary Outcome Measure Information:
Title
Efficacy of OMA102 1 mg and OMA102 2 mg in the promotion of hair growth in the mid front area assessed by digital phototrichogram.
Description
Variation of hair in the mid-front area after 6 months of treatment in comparison to baseline, assessed by digital phototrichogram.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Efficacy of OMA102 1 mg and OMA102 2 mg in the promotion of hair growth in the mid front area assessed by digital phototrichogram.
Description
Variation of hair in the mid-front area after 3 months of treatment in comparison to baseline, assessed by digital phototrichogram.
Time Frame
3 months
Title
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.
Description
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.
Time Frame
3 and 6 months
Title
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.
Description
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.
Time Frame
3 and 6 months
Title
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.
Description
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.
Time Frame
3 and 6 months
Title
Efficacy of OMA102 1 mg and OMA102 2 mg in quality of life, assessed by Women's Androgenetic Alopecia Quality of Life (WAA-QoL).
Description
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.
Time Frame
3 and 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cassiano Ricardo O Berto, B.S.
Phone
+551938877724
Email
pesquisa.clinica@ncfarma.com.br
Facility Information:
Facility Name
EMS
City
Hortolândia
State/Province
São Paulo
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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