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Trial record 4 of 41 for:    MINOXIDIL (FOR MEN) OR LONOLOX OR WOMEN'S ROGAINE OR ROGAINE (FOR MEN) OR LONITEN OR THEROXIDIL OR ROGAINE EXTRA STRENGTH (FOR MEN) OR U-10,858 OR MEN'S ROGAINE OR REGAINE FOR MEN OR MINOXIDIL OR MINOXIDIL EXTRA STRENGTH (FOR MEN) OR REGAINE FOR WOMEN OR MINODYL

Platelet Rich Plasma Versus Minoxidil Foam for Treatment of Androgenic Alopecia in Women

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ClinicalTrials.gov Identifier: NCT03488108
Recruitment Status : Active, not recruiting
First Posted : April 4, 2018
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Alison J. Bruce, Mayo Clinic

Brief Summary:
The primary objective of this proposal is to conduct a study that assesses the safety, feasibility and efficacy of using PRP to treat this type of hair loss.

Condition or disease Intervention/treatment Phase
Alopecia Other: Platelet Rich Plasma Drug: Minoxidil Foam Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Comparing Platelet Rich Plasma (PRP) to Minoxidil Foam for Treatment of Androgenic Alopecia in Women
Actual Study Start Date : January 23, 2017
Actual Primary Completion Date : May 31, 2018
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Minoxidil

Arm Intervention/treatment
Experimental: Platelet Rich Plasma first, then Minoxidil Foam
Subjects will be randomized into the Platelet Rich Plasma group, treated for 12 weeks with a 2 month washout period in between treatments, then treated with Minoxidil Foam for 12 weeks.
Other: Platelet Rich Plasma
Autologous Platelet Rich Plasma (PRP) will be isolated from blood collected from each subject at each treatment time point. 100 cc of PRP will be injected with a 30-gauge needle over the affected part of the scalp, approximately 1/10 cc/injection site. Treatments will take place every 4 weeks for a total of 3 treatments over 12 weeks.

Drug: Minoxidil Foam
Minoxidil 5% topical foam will be applied once daily following manufacturer's instructions for a total of 12 weeks.
Other Name: Rogaine

Experimental: Minoxidil Foam first, then Platelet Rich Plasma
Subjects will be randomized into the Minoxidil Foam group, treated for 12 weeks with a 2 month washout period in between treatments, then treated with Platelet Rich Plasma.
Other: Platelet Rich Plasma
Autologous Platelet Rich Plasma (PRP) will be isolated from blood collected from each subject at each treatment time point. 100 cc of PRP will be injected with a 30-gauge needle over the affected part of the scalp, approximately 1/10 cc/injection site. Treatments will take place every 4 weeks for a total of 3 treatments over 12 weeks.

Drug: Minoxidil Foam
Minoxidil 5% topical foam will be applied once daily following manufacturer's instructions for a total of 12 weeks.
Other Name: Rogaine




Primary Outcome Measures :
  1. Hair Growth [ Time Frame: after 12 weeks of treatment ]
  2. Mean morbidity symptoms [ Time Frame: after 12 weeks of treatment ]

Secondary Outcome Measures :
  1. Mean Level of Pain at PRP Injection Sites [ Time Frame: after 12 weeks of treatment ]
  2. Number of Subjects Experiencing Swelling on Scalp [ Time Frame: after 12 weeks of treatment ]
  3. Number of Subjects Experiencing Erythema on Scalp [ Time Frame: after 12 weeks of treatment ]
  4. Number of Subjects Experiencing Warmth on Scalp [ Time Frame: after 12 weeks of treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Only female patients are eligible
  2. Patients must be 18 years of age or older
  3. Patients must have Androgenic Alopecia Grade I-II by Ludwig Classification
  4. Patients must have been on stable birth control if premenopausal.
  5. Patients are able and willing to provide written informed consent after the nature of the study is fully explained

Exclusion Criteria:

  1. Patients with clinically abnormal hematology, serum chemistry, or screening laboratory results as reviewed by the Principal Investigator
  2. Patients who have undergone topical and systemic therapies for hair loss 3 months prior to the procedure
  3. Patients who have used any cosmetic product meant to address hair loss 3 months prior to enrollment
  4. Patients taking anti-rheumatic disease medication (including methotrexate or other anti-metabolites) within the 3 months prior to study entry.
  5. Patients previously having undergone hair transplant surgery prior to study entry
  6. Patients who are pregnant or currently breast-feeding children as Rogaine for Women is contra indicated for these women
  7. Patients who have taken spironolactone in the 3 months prior to study participation
  8. Patients with systemic, rheumatic or inflammatory disease or who are immunosuppressed
  9. Patients with ongoing infectious disease, including HIV and hepatitis
  10. Patients with clinically significant cardiovascular, renal, hepatic, endocrine disease, cancer, or diabetes
  11. Patients participating in a study of an experimental drug or medical device within 30 days of study entry
  12. Patients with history of platelet disorders, bone marrow aplasia, sepsis, or cancer in the last 5 years.
  13. Patients taking antiaggregating therapy
  14. Patients on anticoagulant therapy
  15. Patients with tendency to keloid formation
  16. Patients with uncompensated diabetes
  17. Patients with active skin disease or skin infection at intended treatment areas

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): NCT03488108


Locations
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United States, Florida
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Alison Bruce, M.B. Ch.B Mayo Clinic Florida

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Responsible Party: Alison J. Bruce, Associate Professor of Dermatology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03488108     History of Changes
Other Study ID Numbers: 16-003335
First Posted: April 4, 2018    Key Record Dates
Last Update Posted: July 2, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Minoxidil
Antihypertensive Agents
Vasodilator Agents