NCT05435625

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 28, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

June 28, 2022

Status Verified

June 1, 2022

Enrollment Period

8 months

First QC Date

March 11, 2022

Last Update Submit

June 23, 2022

Conditions

Androgenic Alopecia

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (2)

FCO2

ACTIVE COMPARATOR

Fractional Carbon dioxide laser

Procedure: FCO2

FRF

ACTIVE COMPARATOR

Fractional Microneedling Radiofrequency

Procedure: FRF

Interventions

FCO2PROCEDURE

Fractional Carbon dioxide laser

FCO2
FRFPROCEDURE

Fractional Microneedling Radiofrequency

FRF

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • both genders are included.
  • Patients above 18 years old.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Al Ainy Hospital

Cairo, El Manial, 11956, Egypt

RECRUITING

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Rana Hilal, MD

CONTACT

2010014888rana.hilal@kasralainy.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 11, 2022

First Posted

June 28, 2022

Study Start

January 1, 2022

Primary Completion

September 1, 2022

Study Completion

December 1, 2022

Last Updated

June 28, 2022

Record last verified: 2022-06

Locations

EG(1)