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Fractional 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
Kasr El Aini Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Androgenic Alopecia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

First Posted
March 11, 2022
Last Updated
June 23, 2022
Sponsor
Kasr El Aini Hospital
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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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