HirsuitismNCT05739799
To Comapre The Effectiveness of Two Lasers in The Treamment of Unwanted Hair
A study testing IPL and Diode in people with Hirsuitism, run by Combined Military Hospital Abbottabad at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Hirsuitism
- What is being tested?
- IPL and Diode
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 11 May 2022to 11 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients with hirsuitism were included in the study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hirsuitism
- Being tested
- IPL, Diode
- Medical subject headings
- Hirsutism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPLProcedure or surgery
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.
DiodeProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A Intense pulse light laser | Active comparator | 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 Receives: Procedure: IPL |
| Group B Diode laser | Active comparator | 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. Receives: Procedure: Diode |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start11 May 2022
- Primary completion11 Nov 2022
- Study completion11 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HirsuitismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Combined Military Hospital Abbottabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Ilyas, Combined Military Hospital Abbottabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05739799
- Sponsor's protocol ID
- CMH-ETH-18-DERM-22
- Status last verified
- Feb 2023
- First submitted
- 18 Jan 2023
- Last updated
- 22 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compariosn of Effectiveness of Diode Laser System Versus Intense Pulse Light (IPL) in The Treatment of Unwanted Hair
- ClinicalTrials.gov ID
- NCT05739799
- Acronym / sponsor ID
- CMH-ETH-18-DERM-22
- Conditions
- Hirsuitism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Combined Military Hospital AbbottabadUniversity, hospital or other
- Study start
- 11 May 2022 (actual)
- Primary completion
- 11 Nov 2022 (actual)
- Study completion
- 11 Nov 2022 (actual)
- First posted
- 22 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A Intense pulse light laser | Active comparator | Procedure: IPLIPL 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 |
| Group B Diode laser | Active comparator | Procedure: DiodeDiode 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Female patients with hirsuitism were included in the study.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IPLPatients 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 or surgery | Group A Intense pulse light laser |
| Diodepatients 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 or surgery | Group B Diode laser |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IPL and Diode in people with Hirsuitism, run by Combined Military Hospital Abbottabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of diode and IPL laser in hirsuitism (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2023.