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CompletedNCT05739799Updated Feb 22, 2023

To Comapre The Effectiveness of Two Lasers in The Treamment of Unwanted Hair

An interventional study of IPL and Diode in Hirsuitism, sponsored by Combined Military Hospital Abbottabad. Completed at 1 site in Pakistan. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-02-22.

Sponsored by Combined Military Hospital Abbottabad · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Female
01

Study summary

A total of 60 female patients (30 patients in each group) with unwanted facial hair diagnosed by a consultant dermatologist were included in this study. In Group A patients were subjected to intense pulse light therapy while patients in Group B were subjected to diode laser for three sessions one month apart. Effectiveness in both groups was ascertained in terms of hair reduction, less adverse effects, side effects and patients' satisfactory response at the end of final session.

02

Conditions studied

  • Hirsuitism

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03

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Female patients with hirsuitism were included in the study.

Exclusion criteria

Exclusion Criteria:

  • tendency to develop hypertrophic scarring/keloid,
  • underwent any treatment for unwanted facial hair in last two years
  • pregnant/lactating women
  • with hormonal imbalance and PCOS were also not in included in the study.
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    Group A Intense pulse light laser

    IPL laser Patients in Group A received intense pulse light (IPL) frequency of 690. A total of three sessions were carried out one month apart, and hair reduction was assessed by seeing thickness of hair and by counting the number of hair follicles in a 1cm2 area on each side of the face before the first session and at the 4th month. A consultant dermatologist assessed the reduction in hair count on the affected side of face at the end of last session. Patients' response and any adverse effects experienced by patients' were recorded

    Procedure: IPL

  • Active comparator
    Group B Diode laser

    Diode laser patients in Group B received diode laser treatment system. Diode laser was employed using triple wavelength (1064, 810 and 755 mm). A total of three sessions were carried out one month apart, and hair reduction was assessed by seeing thickness of hair and by counting the number of hair follicles in a 1cm2 area on each side of the face before the first session and at the 4th month. A consultant dermatologist assessed the reduction in hair count on the affected side of face at the end of last session. Patients' response and any adverse effects experienced by the patients were recorded.

    Procedure: Diode

Interventions

  • ProcedureIPL

    Patients in Group A received intense pulse light (IPL) frequency of 690. A total of three sessions were carried out one month apart, and hair reduction was assessed by seeing thickness of hair and by counting the number of hair follicles in a 1cm2 area on each side of the face before the first session and at the 4th month. A consultant dermatologist assessed the reduction in hair count on the affected side of face at the end of last session. Patients' response and any adverse effects experienced by patients' were recorded.

  • ProcedureDiode

    patients in Group B received diode laser treatment system. Diode laser was employed using triple wavelength (1064, 810 and 755 mm). A total of three sessions were carried out one month apart, and hair reduction was assessed by seeing thickness of hair and by counting the number of hair follicles in a 1cm2 area on each side of the face before the first session and at the 4th month. A consultant dermatologist assessed the reduction in hair count on the affected side of face at the end of last session. Patients' response and any adverse effects experienced by the patients were recorded.

05

What researchers measure

Primary outcomes

  1. Effectiveness of diode and IPL laser in hirsuitism

    A total of 60 female patients (30 patients in each group) with unwanted facial hair diagnosed by a consultant dermatologist were included in this study. In Group A patients were subjected to intense pulse light therapy while patients in Group B were subjected to diode laser for three sessions one month apart. Effectiveness in both groups was ascertained in terms of hair reduction, less adverse effects, side effects, and patients' satisfactory response at the end of final session.After the "response at the end of final session the total duration of the therapy will be 12 weeks.

    Time frame: 12 weeks

06

Study locations

1 site
  • Sara Ilyas
    Abbottābād, Kpk 22010, Pakistan
07

Registry details

Key details

Study ID
NCT05739799
Lead sponsor
Combined Military Hospital Abbottabad
Responsible party
Sara Ilyas (Principal Investigator, Combined Military Hospital Abbottabad) — Principal investigator
First posted
Feb 22, 2023
Start date
May 11, 2022
Primary completion
Nov 11, 2022
Completion
Nov 11, 2022
Last update
Feb 22, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
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