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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05435625
Other study ID # Laser-RF:AGA
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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