Fractional Laser Versus Radiofrequency in Androgenetic Alopecia

Androgenic Alopecia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05435625
• Other study ID #: Laser-RF:AGA
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 1, 2022

Study information

• Verified date: June 2022
• Source: Kasr El Aini Hospital
• Contact: Rana Hilal, MD
• Phone: 2010014888
• Email: rana.hilal[@]kasralainy.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Androgenic Alopecia

Intervention

Procedure:
• FCO2
Fractional Carbon dioxide laser
• FRF
Fractional Microneedling Radiofrequency

Locations

Country	Name	City	State
Egypt	Kasr Al Ainy Hospital	Cairo	El Manial

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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