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

Sponsor

Combined Military Hospital Abbottabad (Other)

Overall Status

Completed

CT.gov ID

NCT05739799

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

9.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hirsuitism	Procedure: IPL Procedure: Diode	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Compariosn of Effectiveness of Diode Laser System Versus Intense Pulse Light (IPL) in The Treatment of Unwanted Hair

Actual Study Start Date :

May 11, 2022

Actual Primary Completion Date :

Nov 11, 2022

Actual Study Completion Date :

Nov 11, 2022

Arms and Interventions

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	Procedure: IPL 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.	Procedure: Diode 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.

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

Procedure: IPL

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.

Procedure: Diode

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.

Outcome Measures

Primary Outcome Measures

Effectiveness of diode and IPL laser in hirsuitism [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sara Ilyas	Abbottābād	Kpk	Pakistan	22010

Sponsors and Collaborators

Combined Military Hospital Abbottabad

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sara Ilyas, Principal Investigator, Combined Military Hospital Abbottabad

ClinicalTrials.gov Identifier:

NCT05739799

Other Study ID Numbers:

CMH-ETH-18-DERM-22

First Posted:

Feb 22, 2023

Last Update Posted:

Feb 22, 2023

Last Verified:

Feb 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hirsutism

Study Results

No Results Posted as of Feb 22, 2023