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Effectiveness and Safety of Minoxidil Foam Versus Placebo Foam for Androgenetic Alopecia

Primary Purpose

Androgenetic Alopecia

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Minoxidil

vehicle of 5% Minoxidil topical foam

About this trial

This is an interventional treatment trial for Androgenetic Alopecia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Male, age 18 to 70 year old, in general good health
Exhibits male AGA based on a discernable hair loss in temple and vertex region rating Hamilton-Norwood Scale III vertex to VI (See Appendix 1)
Subjects who give their consent to the study after thorough explanation and who personally signed and dated the informed consent document indicating that the subject, has been informed of all pertinent aspects of the trial
Willing to maintain the same hairstyle, hair length and hair color throughout the study
Subjects who are willing and able to comply with scheduled visits, treatment plan, mini-tattoo and other trial procedures
Accepting the Information form plus accepting and signing the Informed Consent form

Exclusion Criteria:

Known to be hypersensitive to minoxidil, hair dye (p-phenylenediamine), tattoo ink, fragrances, hair gel or any vehicle components
Current or 4 weeks dated back use of medical shampoos or solutions which include Ketoconazole or the like (e. g. Terzolin®) in the target region interfering with the CTM or examination method
Current or 3 months dated back use of topical treatment in the target regions taken for more then 2 consecutive weeks interfering with the CTM (topical corticosteroids, aminexil, minoxidil, estrogens)
Current or 3 months dated back use of systemic treatment (drugs or dietary supplement) taken for more than 2 consecutive weeks interfering with the CTM or examination method (beta blocker, cimetidine, diazoxide, isotretionin, corticosteroids, vitamin A intake above 10000 IU per day)
Current or 12 months dated back use of Finasteride (Propecia®, FinaHair®, etc.), Dutasteride or a similar product
Within past 12 months undergoing chemotherapy or receiving cytotoxic agents as well as radiation and/or laser/surgical therapy of the scalp
Current or prior enrollment in any other investigational medication (drug) study within the 4 weeks prior to study initiation
Presence of hair transplants, hair weaves or non-breathable wigs and hair bonding
Current or 2 months dated back severe diet or presenting a history of eating disorder
Any dermatological disorders of the scalp in the target region with the possibility of interfering with the CTM or examination method, such as fungal or bacterial infections, seborrheic dermatitis, psoriasis, eczema, folliculitis, scars or scalp atrophy
Untreated persisting hypertension
Active hair loss or history within the past 3 months including diffuse telogen effluvium, alopecia areata, scarring alopecia
Other severe, acute or chronic medical condition that may lead to hair loss or interfere with the interpretation of trial results (e. g. untreated hypothyroidism)
Individuals who are institutionalized by court or regulatory order

Sites / Locations

Charité-Universitätsmedizin Berlin, Clinical Research Center for Hair and Skin Science, Dept. of Dermatology, Venereology and Allergy

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

vehicle of 5% Minoxidl topical foam

5% Minoxidil topical foam

Arm Description

vehicel foam in twice daily application in temple and vertex region

5% Minoxidil topical in twice daily application in temple and vertex region

Outcomes

Primary Outcome Measures

Change of target area non-vellus hair count in the temple region (t-TAHC) [n/cm²] compared to baseline after 24 weeks

Secondary Outcome Measures

Assessing the investigational products safety by means of clinical examination (local intolerance, AE, SAE)

Change of cumulative hair width in non-vellus hair in temple and vertex region (t-TAHW; v-TAHW) [mm/cm²] compared to baseline after 24, 52, 76 and 104 weeks

Change of t-TAHC, v-TAHC, t-TAHW and v-TAHW comparing 5% MTF and Placebo Topical Foam (plaTF) groups

Global expert panel and subjects' rating change in scalp coverage: week 24 compared to baseline, week 104 compared to baseline and week 104 compared to week 24 via assessment of global temple and vertex photographs

Full Information

NCT ID

NCT01319370

First Posted

March 18, 2011

Last Updated

November 6, 2013

Sponsor

Natalie GARCIA BARTELS

Collaborators

Johnson & Johnson

1. Study Identification

Unique Protocol Identification Number

NCT01319370

Brief Title

Effectiveness and Safety of Minoxidil Foam Versus Placebo Foam for Androgenetic Alopecia

Official Title

Investigator-Initiated, Double Blind, Two-Armed, Placebo-Controlled, Randomized Clinical Trial With an Open-Label Extension Phase, to Investigate Efficacy of 5% Minoxidil Topical Foam Twice Daily in Men With Androgenetic Alopecia in the Temple and Vertex Region Concerning Hair Volume Over 24 / 104 Weeks

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Completed

Study Start Date

November 2010 (undefined)

Primary Completion Date

March 2013 (Actual)

Study Completion Date

March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Natalie GARCIA BARTELS

Collaborators

Johnson & Johnson

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The current study aims to show efficacy of twice daily application of 5% Minoxidil Topical Foam (MTF) formulation compared to placebo in the temple region of male patients with androgenetic alopecia after 24 weeks as well as to gain long-term data on the efficacy and safety of 5% MTF in male subjects with AGA in temple and vertex region, over a period of 2 years. Objective and subjective efficacy measures will be compared to baseline. Moreover, all patients will get the equal treatment and measurements in the vertex region to enable comparison of the efficacy of 5% Minoxidil Topical Foam in the temples not only to baseline but also to vertex region. Additionally safety assessments will be performed throughout the whole study.

6. Conditions and Keywords

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

Androgenetic Alopecia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

vehicle of 5% Minoxidl topical foam

Arm Type

Placebo Comparator

Arm Description

vehicel foam in twice daily application in temple and vertex region

Arm Title

5% Minoxidil topical foam

Arm Type

Active Comparator

Arm Description

5% Minoxidil topical in twice daily application in temple and vertex region

Intervention Type

Drug

Intervention Name(s)

Minoxidil

Intervention Description

1 g of 5% Minoxidil topical foam twice daily over 24 weeks in double-blinded phase and further 80 weeks in open-label-phase

Intervention Type

Drug

Intervention Name(s)

vehicle of 5% Minoxidil topical foam

Intervention Description

1 g of vehicle topical foam twice daily over 24 weeks in double-blinded phase and further 80 weeks in open-label-phase

Primary Outcome Measure Information:

Title

Change of target area non-vellus hair count in the temple region (t-TAHC) [n/cm²] compared to baseline after 24 weeks

Time Frame

Baseline, week 8, week 16, week 24, week 52, week 76, week 104

Secondary Outcome Measure Information:

Title

Assessing the investigational products safety by means of clinical examination (local intolerance, AE, SAE)

Time Frame

every visit from baseline to week 104

Title

Change of cumulative hair width in non-vellus hair in temple and vertex region (t-TAHW; v-TAHW) [mm/cm²] compared to baseline after 24, 52, 76 and 104 weeks

Time Frame

Baseline, week 8, week 16, week 24, week 52, week 76, week 104

Title

Change of t-TAHC, v-TAHC, t-TAHW and v-TAHW comparing 5% MTF and Placebo Topical Foam (plaTF) groups

Time Frame

Baseline, week 8, week 16, week 24, week 52, week 76, week 104

Title

Time Frame

Baseline, week 8, week 16, week 24, week 52, week 76, week 104

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male, age 18 to 70 year old, in general good health Exhibits male AGA based on a discernable hair loss in temple and vertex region rating Hamilton-Norwood Scale III vertex to VI (See Appendix 1) Subjects who give their consent to the study after thorough explanation and who personally signed and dated the informed consent document indicating that the subject, has been informed of all pertinent aspects of the trial Willing to maintain the same hairstyle, hair length and hair color throughout the study Subjects who are willing and able to comply with scheduled visits, treatment plan, mini-tattoo and other trial procedures Accepting the Information form plus accepting and signing the Informed Consent form Exclusion Criteria: Known to be hypersensitive to minoxidil, hair dye (p-phenylenediamine), tattoo ink, fragrances, hair gel or any vehicle components Current or 4 weeks dated back use of medical shampoos or solutions which include Ketoconazole or the like (e. g. Terzolin®) in the target region interfering with the CTM or examination method Current or 3 months dated back use of topical treatment in the target regions taken for more then 2 consecutive weeks interfering with the CTM (topical corticosteroids, aminexil, minoxidil, estrogens) Current or 3 months dated back use of systemic treatment (drugs or dietary supplement) taken for more than 2 consecutive weeks interfering with the CTM or examination method (beta blocker, cimetidine, diazoxide, isotretionin, corticosteroids, vitamin A intake above 10000 IU per day) Current or 12 months dated back use of Finasteride (Propecia®, FinaHair®, etc.), Dutasteride or a similar product Within past 12 months undergoing chemotherapy or receiving cytotoxic agents as well as radiation and/or laser/surgical therapy of the scalp Current or prior enrollment in any other investigational medication (drug) study within the 4 weeks prior to study initiation Presence of hair transplants, hair weaves or non-breathable wigs and hair bonding Current or 2 months dated back severe diet or presenting a history of eating disorder Any dermatological disorders of the scalp in the target region with the possibility of interfering with the CTM or examination method, such as fungal or bacterial infections, seborrheic dermatitis, psoriasis, eczema, folliculitis, scars or scalp atrophy Untreated persisting hypertension Active hair loss or history within the past 3 months including diffuse telogen effluvium, alopecia areata, scarring alopecia Other severe, acute or chronic medical condition that may lead to hair loss or interfere with the interpretation of trial results (e. g. untreated hypothyroidism) Individuals who are institutionalized by court or regulatory order

Facility Information:

Facility Name

Charité-Universitätsmedizin Berlin, Clinical Research Center for Hair and Skin Science, Dept. of Dermatology, Venereology and Allergy

City

Berlin

ZIP/Postal Code

10117

Country

Germany

12. IPD Sharing Statement

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Effectiveness and Safety of Minoxidil Foam Versus Placebo Foam for Androgenetic Alopecia

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