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Trial record 16 of 103 for:    "androgenetic alopecia" OR "female pattern baldness" OR "male pattern baldness"

A Study of the Safety, Tolerability, and Efficacy of Topical SM04554 Solution in Male Subjects With Androgenetic Alopecia (AGA)

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ClinicalTrials.gov Identifier: NCT02275351
Recruitment Status : Completed
First Posted : October 27, 2014
Last Update Posted : November 26, 2015
Sponsor:
Information provided by (Responsible Party):
Samumed LLC

Brief Summary:
The purpose of this study is to characterize the safety, tolerability, and efficacy of topical SM04554 solution (0.15% and 0.25%) applied to the scalp of male subjects with Androgenetic Alopecia (AGA).

Condition or disease Intervention/treatment Phase
Androgenetic Alopecia Drug: SM04554 Drug: Vehicle Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 310 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle- Controlled Study of the Safety, Tolerability, and Efficacy of 0.15% and 0.25% Concentrations of Topical SM04554 Solution in Male Subjects With Androgenetic Alopecia (AGA)
Study Start Date : November 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active Arm 1
Topical SM04554 0.15% solution, applied once a day for 90 days
Drug: SM04554
Topical solution, applied once a day

Experimental: Active Arm 2
Topical SM04554 0.25% solution, applied once a day for 90 days
Drug: SM04554
Topical solution, applied once a day

Placebo Comparator: Vehicle Arm
Topical vehicle solution, applied once a day for 90 days
Drug: Vehicle
Topical solution, applied once a day




Primary Outcome Measures :
  1. Change in non-vellus hair count [ Time Frame: Baseline, Day 45, Day 90 ]
    Change in non-vellus hair count over time as compared to Baseline. Non-vellus hair count will be determined by macrophotography.

  2. Change in subject assessment of hair growth and quality [ Time Frame: Day 45, Day 90 ]
    Change in Men's Hair Growth Questionnaire (MHGQ) over time as compared to Baseline. The MHGQ is a subject-completed assessment that asks the subject to evaluate his hair growth and quality since the start of the study.


Secondary Outcome Measures :
  1. Change in hair growth as assessed by the investigator [ Time Frame: Day 45, Day 90 ]
    Change in hair growth over time as compared to Baseline, as assessed by the investigator, using a 7-point scale from -3 (greatly decreased) to +3 (greatly increased).

  2. Impact of AGA on quality of life [ Time Frame: Baseline, Day 45, Day 90 ]
    Change in subject responses to the Kingsley Alopecia Profile (KAP) questionnaire over time as compared to Baseline. The KAP is a 38-question survey completed by each subject that assesses his quality of life in relation to AGA.

  3. Change in hair density [ Time Frame: Baseline, Day 45, Day 90 ]
    Change in hair density over time as compared to Baseline. Hair density will be measured using macrophotography.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of AGA
  • Willing to inform females, with whom they may interact, that they are using a topical investigational product and direct contact should be avoided as potential harm to a fetus is unknown
  • Willing to maintain the same hair style as at study start for the duration of the study
  • Willing to not use semi-permanent hair products (e.g., color, texturizers, relaxers) for the duration of the study. Daily styling products will be allowed (e.g., hair gel, mousse, styling spray).
  • Willing to use a mild non-medicated shampoo and conditioner for the duration of the study
  • Willing to receive a small scalp tattoo
  • Able to read and understand English

Exclusion Criteria:

  • Clinical diagnosis of alopecia areata or other non-AGA forms of alopecia
  • Scalp hair loss on the treatment area, due to disease, injury, or medical therapy
  • Males who are sexually active and have a partner who is capable of becoming pregnant, neither of whom have had surgery to become sterilized, that are not using an effective method of birth control and are not willing to use an effective method of birth control during the study treatment period until 90 days post last dose of study medication
  • Current skin disease (e.g., psoriasis, atopic dermatitis, skin cancer, eczema, sun damage, seborrheic dermatitis), cuts and/or abrasions on the scalp or condition (e.g., sunburn, tattoos) on the treatment area that, in the opinion of the Investigator, might put the subject at risk or interfere with the study conduct or evaluations
  • History of surgical correction of hair loss on the scalp
  • Previous exposure to SM04554
  • Use of any products or devices purported to promote scalp hair growth (e.g., finasteride or minoxidil) within the 24 weeks prior to study start
  • Use of anti-androgenic therapies (e.g., spironolactone, flutamide, cyproterone acetate, cimetidine) within 12 weeks prior to study start
  • History of hair transplants
  • Current use of an occlusive wig, hair extensions, or hair weaves
  • Participation in any other investigational drug or medical device trial, which included administration of an investigational study medication or medical device, within 30 days or 5 half-lives of the investigational agent, whichever is longer, prior to study start
  • Subjects with a history of clinically significant cardiac arrhythmia as determined by the Investigator
  • Subjects with clinically significant findings from medical history, clinical laboratory tests, electrocardiogram (ECG), or vital signs that, in the opinion of the Investigator, could interfere with the objectives of the study or put the subject at risk
  • Subjects unwilling to refrain from sperm donation during the study treatment period until 90 days post last dose of study medication
  • Subjects with pregnant partners at study start
  • Use of semi-permanent hair products (e.g., color, texturizers, relaxers) within 30 days prior to study start
  • Use of medicated shampoo or conditioner within 30 days prior to study start

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02275351


  Show 24 Study Locations
Sponsors and Collaborators
Samumed LLC
Investigators
Study Director: Yusuf Yazici, M.D. Samumed LLC

Responsible Party: Samumed LLC
ClinicalTrials.gov Identifier: NCT02275351     History of Changes
Other Study ID Numbers: SM04554-AGA-02
First Posted: October 27, 2014    Key Record Dates
Last Update Posted: November 26, 2015
Last Verified: November 2015

Keywords provided by Samumed LLC:
alopecia
topical
Samumed

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Pharmaceutical Solutions