Back to resultsTo Comapre The Effectiveness of Two Lasers in The Treamment of Unwanted Hair
Primary Purpose
Hirsuitism
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
IPL
Diode
Sponsored by
About this trial
This is an interventional other trial for Hirsuitism
Eligibility Criteria
Inclusion Criteria: Female patients with hirsuitism were included in the study. 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.
Sites / Locations
- Sara Ilyas
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A Intense pulse light laser
Group B Diode laser
Arm Description
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
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05739799
First Posted
January 18, 2023
Last Updated
February 13, 2023
Sponsor
Combined Military Hospital Abbottabad
1. Study Identification
Unique Protocol Identification Number
NCT05739799
Brief Title
To Comapre The Effectiveness of Two Lasers in The Treamment of Unwanted Hair
Official Title
Compariosn of Effectiveness of Diode Laser System Versus Intense Pulse Light (IPL) in The Treatment of Unwanted Hair
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
May 11, 2022 (Actual)
Primary Completion Date
November 11, 2022 (Actual)
Study Completion Date
November 11, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Combined Military Hospital Abbottabad
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hirsuitism
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A Intense pulse light laser
Arm Type
Active Comparator
Arm Description
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
Arm Title
Group B Diode laser
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
IPL
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Diode
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effectiveness of diode and IPL laser in hirsuitism
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female patients with hirsuitism were included in the study.
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.
Facility Information:
Facility Name
Sara Ilyas
City
Abbottābād
State/Province
Kpk
ZIP/Postal Code
22010
Country
Pakistan
12. IPD Sharing Statement
Learn more about this trial
To Comapre The Effectiveness of Two Lasers in The Treamment of Unwanted Hair
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