- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05739799
To Comapre The Effectiveness of Two Lasers in The Treamment of Unwanted Hair
February 13, 2023 updated by: Sara Ilyas, Combined Military Hospital Abbottabad
Compariosn of Effectiveness of Diode Laser System Versus Intense Pulse Light (IPL) in The Treatment of Unwanted Hair
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kpk
-
Abbottābād, Kpk, Pakistan, 22010
- Sara Ilyas
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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
|
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.
|
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effectiveness of diode and IPL laser in hirsuitism
Time Frame: 12 weeks
|
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.
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 11, 2022
Primary Completion (Actual)
November 11, 2022
Study Completion (Actual)
November 11, 2022
Study Registration Dates
First Submitted
January 18, 2023
First Submitted That Met QC Criteria
February 13, 2023
First Posted (Estimate)
February 22, 2023
Study Record Updates
Last Update Posted (Estimate)
February 22, 2023
Last Update Submitted That Met QC Criteria
February 13, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMH-ETH-18-DERM-22
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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