Back to resultsRadiofrequency in Female Pattern Hair Loss
Primary Purpose
Female Pattern Baldness
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vivacy
Sponsored by
About this trial
This is an interventional treatment trial for Female Pattern Baldness
Eligibility Criteria
Inclusion Criteria:
- Patients with female pattern hair loss
Exclusion Criteria:
- - Pregnancy and lactation.
- Bleeding tendency.
- Cases who received treatment (systemic or topical) in the last 3 months before treatment.
- Scarring alopecia.
- Other associated causes of alopecia
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Fractional microneedling radiofrequency
Fractional microneedling radiofrequency followed by minoxidil application
Minoxidil
Arm Description
Device
Device and drug
Topical drug
Outcomes
Primary Outcome Measures
Clinical examination by Sinclair scale
Clinical
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05409755
Brief Title
Radiofrequency in Female Pattern Hair Loss
Official Title
Efficacy of Fractional Needling Radiofrequency in Female Pattern Hair Loss, a Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 25, 2022 (Anticipated)
Primary Completion Date
September 15, 2022 (Anticipated)
Study Completion Date
September 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Pattern hair loss, also called androgenetic alopecia (AGA) is considered the most common cause of hair loss in both males and females affecting approximately 85% of males and 50% of females over 50 years of age.
Detailed Description
RF (Radiofrequency) based devices have also been shown to be successful in promoting hair growth, thought to occur through the induction of growth factors in the papillary dermis. Studying the effect of fractional needling radiofrequency in the treatment of female pattern hair loss will pave the way for more treatment options for this common disease.
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
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fractional microneedling radiofrequency
Arm Type
Active Comparator
Arm Description
Device
Arm Title
Fractional microneedling radiofrequency followed by minoxidil application
Arm Type
Active Comparator
Arm Description
Device and drug
Arm Title
Minoxidil
Arm Type
Active Comparator
Arm Description
Topical drug
Intervention Type
Other
Intervention Name(s)
Vivacy
Intervention Description
Vivacy and minoxidil
Primary Outcome Measure Information:
Title
Clinical examination by Sinclair scale
Description
Clinical
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with female pattern hair loss
Exclusion Criteria:
- Pregnancy and lactation.
Bleeding tendency.
Cases who received treatment (systemic or topical) in the last 3 months before treatment.
Scarring alopecia.
Other associated causes of alopecia
12. IPD Sharing Statement
Learn more about this trial
Radiofrequency in Female Pattern Hair Loss
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