Alopecia AreataPhase 1/2NCT06239324
Evaluation of Latanoprost Combined With Fractional Erbium- YAG Laser
A Phase 1/2 study testing Latanoprost in people with Alopecia Areata, run by Egymedicalpedia at 1 site in Egypt.
Trial summary
Alopecia areata (AA) an autoimmune disorder of hair follicles results in varying degrees of scalp, facial and body hair loss. Clinically, patients' presentation varies from patchy circumscribed scalp involvement to total body and scalp hair loss affects up to 2% of the general population. Read more about this study
- Who is it for?
- Ages 30 to 35 years
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- Latanoprost
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2024to 1 May 2024
- Phase
- Phase 1/2
- 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 30 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients of both sexes with localized stable alopecia areata of the scalp of 3 months duration at least.
Who cannot join
- Acute or chronic infections.
- Pregnant or lactating women.
- Scarring alopecia.
- Alopecia totalis , Alopecia universalis and ophiasis.
- Autoimmune dermatological diseases.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Qena Hospital
Qina
Eisa Hegazy, Assist.Prof, 01094337795, eisa_mohamed4152@med.svu.edu.eg
About this study
Official title: Evaluation of Latanoprost Combined With Fractional Erbium- YAG Laser Versus Microneedling in Alopecia Areata Treatment
Alopecia areata (AA) an autoimmune disorder of hair follicles results in varying degrees of scalp, facial and body hair loss.
Clinically, patients' presentation varies from patchy circumscribed scalp involvement to total body and scalp hair loss affects up to 2% of the general population.
Read more
The exact pathobiology of AA has still remained elusive, while the common theory is the collapse of the immune privilege of the hair follicle caused by immunological mechanism. Multiple genetic, environment factors and psychological stress contribute to the pathogenesis of Alopecia Areata .
Recent insights into the pathogenesis of AA have led to the development of new treatment strategies, such as Janus kinase inhibitors, biologics and several small molecular agents. In addition, modern therapies for AA, including antihistamines, platelet-rich plasma injection
Read the detailed description
Latanoprost is a prostaglandin analogue with well-established efficacy in the treatment of open-angle glaucoma and ocular hypertension.
Make an increase in the number, thickness and length of eyelashes is an important side effect of latanoprost eye drop. This study aimed to evaluate the effect of hypertrichosis property of latanoprost in the treatment of scalp Alopecia Areata.
Numerous techniques and agents such as microneedling, dermabrasion, radiofrequency and lasers have been used to increase penetration within an approach known as transdermal drug delivery.
One of these techniques is laser-assisted drug delivery (LADD), which often uses ablative fractional lasers (CO2 or erbium: YAG lasers) because of their capacity to produce microscopic ablated channels.
LADD is a promising technique that enhances the absorption of topical molecules while adding the synergic effect.
Microneedling is a form of therapy that utilizes instruments that contain rows of thin needles that penetrate the dermis to uniform depth, creating a controlled skin injury.
Transcutaneous drug delivery via fractional laser and microneedling is a promising modality with preliminary evidence for increased hair regrowth over topical therapy alone.
Trichoscopy is a noninvasive procedure performed in dermatology clinics and is a helpful tool in determining the correct diagnosis of hair loss presentations. The five most characteristic trichoscopic findings in AA are yellow dots, black dots, broken hairs, short vellus hairs and tapering hairs. Also trichoscopy is a useful tool that allows monitoring of response during treatment of AA.
- Conditions
- Alopecia Areata
- Being tested
- Latanoprost
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LatanoprostDrug
Also called fractional Erbium- YAG laser
Comparing between Erbium YAG laser assisted drug delivery of latanoprost versus transepidermal latanoprost delivery by microneedling in alopecia areata treatment for all participants.
| Study group | Role | What they receive |
|---|---|---|
| Fractional Erbium laser Technique (Group A) | Active comparator | About 35 patients with alopecia areata will Subject to fractional Erbium (Er-YAG) laser (Fotona Xs dynamics,Slovenia) with energy of 600 mj in short pulse mode (MSP) with spot size of 7 mm diameter, frequency of 3 Hz and pixel 3. Latanoprost( xalatan 0.005% ) is applied to the treated area for all participants. Receives: Drug: Latanoprost |
| Micro needling Technique (Group B) | Active comparator | About 35 patients with alopecia areata will Subject to micro needling using electronic dermapen device (Dr Pen Derma PenUltima A6) which has a disposable head personalized for each patient and sterilized after each session. the dermapen will penetrate the skin with depth 0.6 mm. It will pass vertically over the affected area in a circular pattern until pinpoint bleeding appears. Latanoprost ( xalatan 0.005% ) is applied to the treated area for all participants. Receives: Drug: Latanoprost |
What is being measured
The primary outcome is the main question the study is designed to answer.
fractional Erbium YAG laser
The Number of Participants With Treatment of fractional Erbium YAG laser assisted delivery of latanoprost versus micro needling with trans-epidermal latanoprost delivery to induce hair growth in alopecia areata.
Measured: from baseline to 3 months after the fractional Erbium YAG laser treatment day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start1 Feb 2024
- Primary completion20 Apr 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia AreataStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Egymedicalpedia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Soheir AbdelHamid Ali, Assist. Prof., Principal investigator, Department of dermatology , Venerolgy and Andrology Faculty of Medicine Qena university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06239324
- Sponsor's protocol ID
- Maha Nabil
- Status last verified
- Apr 2024
- First submitted
- 16 Jan 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Latanoprost Combined With Fractional Erbium- YAG Laser Versus Microneedling in Alopecia Areata Treatment
- ClinicalTrials.gov ID
- NCT06239324
- Acronym / sponsor ID
- Maha Nabil
- Conditions
- Alopecia Areata
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- EgymedicalpediaIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 20 Apr 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 2 Feb 2024 (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.
Alopecia areata (AA) an autoimmune disorder of hair follicles results in varying degrees of scalp, facial and body hair loss.
Clinically, patients' presentation varies from patchy circumscribed scalp involvement to total body and scalp hair loss affects up to 2% of the general population.
The exact pathobiology of AA has still remained elusive, while the common theory is the collapse of the immune privilege of the hair follicle caused by immunological mechanism. Multiple genetic, environment factors and psychological stress contribute to the pathogenesis of Alopecia Areata .
Recent insights into the pathogenesis of AA have led to the development of new treatment strategies, such as Janus kinase inhibitors, biologics and several small molecular agents. In addition, modern therapies for AA, including antihistamines, platelet-rich plasma injection
Detailed description
Latanoprost is a prostaglandin analogue with well-established efficacy in the treatment of open-angle glaucoma and ocular hypertension.
Make an increase in the number, thickness and length of eyelashes is an important side effect of latanoprost eye drop. This study aimed to evaluate the effect of hypertrichosis property of latanoprost in the treatment of scalp Alopecia Areata.
Numerous techniques and agents such as microneedling, dermabrasion, radiofrequency and lasers have been used to increase penetration within an approach known as transdermal drug delivery.
One of these techniques is laser-assisted drug delivery (LADD), which often uses ablative fractional lasers (CO2 or erbium: YAG lasers) because of their capacity to produce microscopic ablated channels.
LADD is a promising technique that enhances the absorption of topical molecules while adding the synergic effect.
Microneedling is a form of therapy that utilizes instruments that contain rows of thin needles that penetrate the dermis to uniform depth, creating a controlled skin injury.
Transcutaneous drug delivery via fractional laser and microneedling is a promising modality with preliminary evidence for increased hair regrowth over topical therapy alone.
Trichoscopy is a noninvasive procedure performed in dermatology clinics and is a helpful tool in determining the correct diagnosis of hair loss presentations. The five most characteristic trichoscopic findings in AA are yellow dots, black dots, broken hairs, short vellus hairs and tapering hairs. Also trichoscopy is a useful tool that allows monitoring of response during treatment of AA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fractional Erbium laser Technique (Group A) | Active comparator | Drug: LatanoprostAbout 35 patients with alopecia areata will Subject to fractional Erbium (Er-YAG) laser (Fotona Xs dynamics,Slovenia) with energy of 600 mj in short pulse mode (MSP) with spot size of 7 mm diameter, frequency of 3 Hz and pixel 3. Latanoprost( xalatan 0.005% ) is applied to the treated area for all participants. |
| Micro needling Technique (Group B) | Active comparator | Drug: LatanoprostAbout 35 patients with alopecia areata will Subject to micro needling using electronic dermapen device (Dr Pen Derma PenUltima A6) which has a disposable head personalized for each patient and sterilized after each session. the dermapen will penetrate the skin with depth 0.6 mm. It will pass vertically over the affected area in a circular pattern until pinpoint bleeding appears. Latanoprost ( xalatan 0.005% ) is applied to the treated area for all participants. |
Who may qualify
- Ages
- 30 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients of both sexes with localized stable alopecia areata of the scalp of 3 months duration at least.
Key exclusion criteria (5 listed)
- Acute or chronic infections.
- Pregnant or lactating women.
- Scarring alopecia.
- Alopecia totalis , Alopecia universalis and ophiasis.
- Autoimmune dermatological diseases.
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 |
|---|---|---|
| LatanoprostAlso: fractional Erbium- YAG laserComparing between Erbium YAG laser assisted drug delivery of latanoprost versus transepidermal latanoprost delivery by microneedling in alopecia areata treatment for all participants. | Drug | Fractional Erbium laser Technique (Group A), Micro needling Technique (Group B) |
Primary outcome
fractional Erbium YAG laser
Time frame: from baseline to 3 months after the fractional Erbium YAG laser treatment day.
The Number of Participants With Treatment of fractional Erbium YAG laser assisted delivery of latanoprost versus micro needling with trans-epidermal latanoprost delivery to induce hair growth in alopecia areata.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Soheir AbdelHamid Ali, Assist. Prof. principal investigator
Department of dermatology , Venerolgy and Andrology Faculty of Medicine Qena university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Latanoprost in people with Alopecia Areata, run by Egymedicalpedia at 1 site in Egypt.
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 5 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: status not confirmed, as of the sponsor's last update on 16 Apr 2024. 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 Egypt. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maha Nabil Fahmy, Resident (01012004848, mahanabilsoady@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fractional Erbium YAG laser (time frame: from baseline to 3 months after the fractional Erbium YAG laser treatment day.). 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 16 Apr 2024.