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

ConditionFemale Pattern Baldness
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorEMS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • OMA102

    Drug

    1 mg

  • OMA102

    Drug

    2 mg

  • Placebo

    Drug

    OMA102 - Placebo

Treatment groups

504 Participants
are divided into 3 treatment groups
Group A: OMA102 1 mgExperimental treatment 1 intervention
Group B: OMA102 2 mgExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
6 months

Secondary outcomes

1

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.

Time frame
3 months
2

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.

Time frame
3 and 6 months
3

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.

Time frame
3 and 6 months
4

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.

Time frame
3 and 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

EMS

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: