HirsuitismPhase 4NCT06976424
Comparison of a Face Cream Plus a Laser Procedure and Face Cream Alone in Treatment of Excessive Face Hairs in Female
A Phase 4 study testing Eflornithine Topical and Instense pulsed light in people with Hirsuitism, run by Khyber Teaching Hospital at 3 sites in Pakistan.
Trial summary
The study compares the effects of a cream alone and a combined effect of cream and laser for the treatment of excessive facial hairs in women . Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Hirsuitism
- What is being tested?
- Eflornithine Topical and Instense pulsed light
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 3 sitesPakistan
- Study dates
- 15 Jul 2025to 31 Dec 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Gender (Female) Age between 18-45 Years Women with hirsutism as mentioned in the operational definition
Who cannot join
- Pregnant women Women with severe acne Women with immunodeficiency
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan3 sites, 3 recruiting
- Recruiting
Khyber Teaching Hospital
Peshawar, Kpk, 25000
- Recruiting
Khyber Teaching Hospital
Peshawar, KPK
Umaima Nazar, MBBS, +923355869079 ext. 03355869079, umaimanazar123@gmail.com
Umaima Nazar, MBBS
- Recruiting
Khyber Teachinng Hospital
Peshawar, KPK
About this study
Official title: Comparison of Eflornithine Cream Combined With Intense Pulsed Light Versus Intense Pulsed Light Alone for Hirsutism in Women
The study compares the effects of a cream alone and a combined effect of cream and laser for the treatment of excessive facial hairs in women .
Read the detailed description
Hirsuitism refers to excessive terminal hairs in females, following a distribution pattern typically associated with male. It is associated with either increase response of hair follicles to androgen or either increase level of circulating androgens.The treatment options available are topical creams like eflornithine and laser treatments for hair removal. This study aims to conduct the comparison of a eflornithine cream and intense pulsed light laser versus eflornithine cream alone for the treatment of excessive facial hairs.
- Conditions
- Hirsuitism
- Being tested
- Eflornithine Topical, Instense pulsed light
- Keywords
- Hirsuitism, IPL, Eflornithine
- Medical subject headings
- Hirsutism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eflornithine TopicalDrug
Also called Eflornithine cream
Eflornithine cream will be applied to the face of group B female patients
Instense pulsed lightRadiation
Intense pulse light will be applied to the face of patient of Group A on areas having increase hair. Patient will be called for a followup every month for next session.
Eflornithine TopicalDrug
Eflornithine will be given to group A patient along with intense pulsed light and results will be compared to group B who recieved only Eflornithine cream
| Study group | Role | What they receive |
|---|---|---|
| GroupA | Experimental | This group is treated with combination of eflornithine cream and intense pulsed light for a period of three month. Receives: Radiation: Instense pulsed light; Drug: Eflornithine Topical |
| Group B | Experimental | This group is treated with eflornithine cream twice daily only for a period of three month Receives: Drug: Eflornithine Topical |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of treatment
Efficacy of treatment is defined as complete clearance of excessive hairs assesed on the basis of 4- level scale ranging 0 to 3 after 3 months of administration of the treatment in both groups.
Clear is grade 3 Marked improvement is grade2 Improved is grade1 No improvement is grade 0
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start15 Jul 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khyber Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Umaima Nazar, Khyber Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06976424
- Sponsor's protocol ID
- 59/DME/KMC
- Status last verified
- Jul 2025
- First submitted
- 9 May 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Because the confedentiality of the patient would be breached.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Eflornithine Cream Combined With Intense Pulsed Light Versus Intense Pulsed Light Alone for Hirsutism in Women
- ClinicalTrials.gov ID
- NCT06976424
- Acronym / sponsor ID
- 59/DME/KMC
- Conditions
- Hirsuitism
- Keywords
- Hirsuitism, IPL, Eflornithine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Khyber Teaching HospitalUniversity, hospital or other
- Study start
- 15 Jul 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 May 2025 (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.
The study compares the effects of a cream alone and a combined effect of cream and laser for the treatment of excessive facial hairs in women .
Detailed description
Hirsuitism refers to excessive terminal hairs in females, following a distribution pattern typically associated with male. It is associated with either increase response of hair follicles to androgen or either increase level of circulating androgens.The treatment options available are topical creams like eflornithine and laser treatments for hair removal. This study aims to conduct the comparison of a eflornithine cream and intense pulsed light laser versus eflornithine cream alone for the treatment of excessive facial hairs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GroupA | Experimental | Radiation: Instense pulsed light, Drug: Eflornithine TopicalThis group is treated with combination of eflornithine cream and intense pulsed light for a period of three month. |
| Group B | Experimental | Drug: Eflornithine TopicalThis group is treated with eflornithine cream twice daily only for a period of three month |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Gender (Female) Age between 18-45 Years Women with hirsutism as mentioned in the operational definition
Key exclusion criteria (1 listed)
- Pregnant women Women with severe acne Women with immunodeficiency
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 |
|---|---|---|
| Eflornithine TopicalAlso: Eflornithine creamEflornithine cream will be applied to the face of group B female patients | Drug | Group B |
| Instense pulsed lightIntense pulse light will be applied to the face of patient of Group A on areas having increase hair. Patient will be called for a followup every month for next session. | Radiation | GroupA |
| Eflornithine TopicalEflornithine will be given to group A patient along with intense pulsed light and results will be compared to group B who recieved only Eflornithine cream | Drug | GroupA |
Primary outcome
Efficacy of treatment
Time frame: 3 months
Efficacy of treatment is defined as complete clearance of excessive hairs assesed on the basis of 4- level scale ranging 0 to 3 after 3 months of administration of the treatment in both groups. Clear is grade 3 Marked improvement is grade2 Improved is grade1 No improvement is grade 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: No. Because the confedentiality of the patient would be breached.
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RecruitingObservational study
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Hypertrichosis, Hirsutism - Hypertrichosis
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Eflornithine Topical and Instense pulsed light in people with Hirsuitism, run by Khyber Teaching Hospital at 3 sites 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 1 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: looking for participants now, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Umaima Nazar, MBBS (+923355869079 ext. +923355869079, umaimanazar123@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of treatment (time frame: 3 months). 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 3 Jul 2025.