Fractional Laser Versus Radiofrequency in Androgenetic Alopecia

Fractional Microneedling Radiofrequency Versus Fractional Carbon Dioxide Laser in Combination With Minoxidil for the Treatment of Androgenetic Alopecia

Patients with Androgenetic alopecia will be randomized into 2 groups; Group FCO2 receiving Fractional CO2 or Group FRF receiving Fractional Microneedling Radiofrequency.

Study Overview

• Status: Recruiting
• Conditions: Androgenic Alopecia
• Intervention / Treatment: Procedure: FCO2; Procedure: FRF

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

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rana Hilal, MD; Phone Number: 2010014888; Email: rana.hilal@kasralainy.edu.eg

Study Locations

• Egypt
  • El Manial
    • Cairo, El Manial, Egypt, 11956
      • Recruiting
      • kasr Al Ainy Hospital
      • Contact: Rana Hilal, MD; Phone Number: 1001488869; Email: rana.hilal@kasralainy.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: FCO2; Fractional Carbon dioxide laser	Procedure: FCO2; Fractional Carbon dioxide laser
ACTIVE_COMPARATOR: FRF; Fractional Microneedling Radiofrequency	Procedure: FRF; Fractional Microneedling Radiofrequency

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6months-1 year
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.	6months-1 year
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.	months-1 year
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.	2 months
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.	6months-1 year

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2022
• Primary Completion (ANTICIPATED): September 1, 2022
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: March 11, 2022
• First Submitted That Met QC Criteria: June 23, 2022
• First Posted (ACTUAL): June 28, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 28, 2022
• Last Update Submitted That Met QC Criteria: June 23, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata
• Other Study ID Numbers: Laser-RF:AGA

Drug and device information, study documents

• 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