CClinicalTrials.gg
Status unknownNCT05435625Updated Jun 28, 2022

Fractional Laser Versus Radiofrequency in Androgenetic Alopecia

An interventional study of FCO2 and FRF in Androgenic Alopecia, sponsored by Kasr El Aini Hospital. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-06-28.

Sponsored by Kasr El Aini Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Androgenic Alopecia
03

In context

Alopecia

609 studies on the registry are indexed under Alopecia; 131 are open to participants now.

This study's planned enrollment of 30 is below the median of 45 across 513 interventional studies indexed under Alopecia.

Browse Alopecia studies →

Lead sponsor

Kasr El Aini Hospital is the lead sponsor of 273 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

    • both genders are included.

      • Patients above 18 years old.

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    FCO2

    Fractional Carbon dioxide laser

    Procedure: FCO2

  • Active comparator
    FRF

    Fractional Microneedling Radiofrequency

    Procedure: FRF

Interventions

  • ProcedureFCO2

    Fractional Carbon dioxide laser

  • ProcedureFRF

    Fractional Microneedling Radiofrequency

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6months-1 year

  2. 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.

    Time frame: 6months-1 year

  3. 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.

    Time frame: months-1 year

  4. 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.

    Time frame: 2 months

  5. 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.

    Time frame: 6months-1 year

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05435625
Lead sponsor
Kasr El Aini Hospital
Responsible party
Rana F Hilal, MD (Assistant Professor, Kasr El Aini Hospital) — Principal investigator
First posted
Jun 28, 2022
Start date
Jan 1, 2022
Primary completion
Sep 1, 2022 (estimated)
Completion
Dec 1, 2022 (estimated)
Last update
Jun 28, 2022

Study contacts

Rana Hilal, MD
Contact
rana.hilal@kasralainy.edu.eg
2010014888

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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