Back to resultsFractional Laser Versus Radiofrequency in Androgenetic Alopecia
Primary Purpose
Androgenic Alopecia
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
FCO2
FRF
Sponsored by
About this trial
This is an interventional treatment trial for Androgenic Alopecia
Eligibility Criteria
Inclusion Criteria:
• both genders are included.
- Patients above 18 years old.
Exclusion Criteria:
• Patients with patchy hair loss.
- Patients with Telogen Effluvium or diffuse alopecia areata.
- Patients with cicatricial alopecias.
- Patients with associated inflammatory scalp disorders such as psoriasis or seborrheic dermatitis.
- Patients with collagen vascular disorders.
- Prior use of topical steroids on scalp in the previous 2 weeks.
- Prior use of systemic steroids in the previous 1 month.
Sites / Locations
- Kasr Al Ainy HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
FCO2
FRF
Arm Description
Fractional Carbon dioxide laser
Fractional Microneedling Radiofrequency
Outcomes
Primary Outcome Measures
Clinical Global improvement Assessment
Photographs will be taken with a Canon camera under controlled light in approximately the same position, taken at baseline, after 4 treatment sessions (16 weeks post treatment) and 2 months after follow-up (24 weeks post treatment). First clinical assessment will be performed based on the clinical change from baseline at 16 weeks post treatment. Change in the clinical will be measured on a 6 point scale; (-1) worsening, (0) no improvement, (1) less than 25% improvement, (2) 25-50% improvement, (3) 50-75% improvement, (4) more than 75% improvement. A higher numerical means a better outcome.
Clinical Global improvement Assessment
Photographs will be taken with a Canon camera under controlled light in approximately the same position, taken at baseline, after 4 treatment sessions (16 weeks post treatment) and 2 months after follow-up (24 weeks post treatment). Second clinical assessment will be performed based on the clinical change from 16 weeks post treatment to 24 weeks post treatment. Change in the clinical will be measured on a 6 point scale; (-1) worsening, (0) no improvement, (1) less than 25% improvement, (2) 25-50% improvement, (3) 50-75% improvement, (4) more than 75% improvement. A higher numerical means a better outcome.
Phototrichogram assessment.
A phototrichogram system (Dino-Lite; AnMo Electronics, Taiwan)will be used to evaluate the number of hairs. A higher numerical means a better outcome.
Phototrichogram assessment.
A phototrichogram system (Dino-Lite; AnMo Electronics, Taiwan)will be used to evaluate the thickness of hairs. A higher numerical means a better outcome.
Patient satisfaction
Participants will be also asked to give their assessment on a scale of 4, (0) no satisfaction (1) slight satisfation, (2) moderate satisfaction, (3) marked satisfaction. A higher numerical means a better outcome.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05435625
Brief Title
Fractional Laser Versus Radiofrequency in Androgenetic Alopecia
Official Title
Fractional Microneedling Radiofrequency Versus Fractional Carbon Dioxide Laser in Combination With Minoxidil for the Treatment of Androgenetic Alopecia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
Patients with Androgenetic alopecia will be randomized into 2 groups; Group FCO2 receiving Fractional CO2 or Group FRF receiving Fractional Microneedling Radiofrequency.
Detailed Description
Group FCO2 will be to receiving fractional CO2 to one randomized side of the scalp, and Group FRF will be receiving Fractional Microneedling radiofrequency to one randomized side of the scalp.
All patients will receive 4 sessions with 4-week intervals.each session will be followed by immediate topical application of 6 puffs (=1 mL) of minoxidil 5% solution twice daily and also in between the sessions and during follow up period
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgenic Alopecia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FCO2
Arm Type
Active Comparator
Arm Description
Fractional Carbon dioxide laser
Arm Title
FRF
Arm Type
Active Comparator
Arm Description
Fractional Microneedling Radiofrequency
Intervention Type
Procedure
Intervention Name(s)
FCO2
Intervention Description
Fractional Carbon dioxide laser
Intervention Type
Procedure
Intervention Name(s)
FRF
Intervention Description
Fractional Microneedling Radiofrequency
Primary Outcome Measure Information:
Title
Clinical Global improvement Assessment
Description
Photographs will be taken with a Canon camera under controlled light in approximately the same position, taken at baseline, after 4 treatment sessions (16 weeks post treatment) and 2 months after follow-up (24 weeks post treatment). First clinical assessment will be performed based on the clinical change from baseline at 16 weeks post treatment. Change in the clinical will be measured on a 6 point scale; (-1) worsening, (0) no improvement, (1) less than 25% improvement, (2) 25-50% improvement, (3) 50-75% improvement, (4) more than 75% improvement. A higher numerical means a better outcome.
Time Frame
6months-1 year
Title
Clinical Global improvement Assessment
Description
Photographs will be taken with a Canon camera under controlled light in approximately the same position, taken at baseline, after 4 treatment sessions (16 weeks post treatment) and 2 months after follow-up (24 weeks post treatment). Second clinical assessment will be performed based on the clinical change from 16 weeks post treatment to 24 weeks post treatment. Change in the clinical will be measured on a 6 point scale; (-1) worsening, (0) no improvement, (1) less than 25% improvement, (2) 25-50% improvement, (3) 50-75% improvement, (4) more than 75% improvement. A higher numerical means a better outcome.
Time Frame
6months-1 year
Title
Phototrichogram assessment.
Description
A phototrichogram system (Dino-Lite; AnMo Electronics, Taiwan)will be used to evaluate the number of hairs. A higher numerical means a better outcome.
Time Frame
months-1 year
Title
Phototrichogram assessment.
Description
A phototrichogram system (Dino-Lite; AnMo Electronics, Taiwan)will be used to evaluate the thickness of hairs. A higher numerical means a better outcome.
Time Frame
2 months
Title
Patient satisfaction
Description
Participants will be also asked to give their assessment on a scale of 4, (0) no satisfaction (1) slight satisfation, (2) moderate satisfaction, (3) marked satisfaction. A higher numerical means a better outcome.
Time Frame
6months-1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• both genders are included.
Patients above 18 years old.
Exclusion Criteria:
• Patients with patchy hair loss.
Patients with Telogen Effluvium or diffuse alopecia areata.
Patients with cicatricial alopecias.
Patients with associated inflammatory scalp disorders such as psoriasis or seborrheic dermatitis.
Patients with collagen vascular disorders.
Prior use of topical steroids on scalp in the previous 2 weeks.
Prior use of systemic steroids in the previous 1 month.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rana Hilal, MD
Phone
2010014888
Email
rana.hilal@kasralainy.edu.eg
Facility Information:
Facility Name
Kasr Al Ainy Hospital
City
Cairo
State/Province
El Manial
ZIP/Postal Code
11956
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rana Hilal, MD
Phone
1001488869
Email
rana.hilal@kasralainy.edu.eg
12. IPD Sharing Statement
Learn more about this trial
Fractional Laser Versus Radiofrequency in Androgenetic Alopecia
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