Microneedling-Assisted DeliveryNCT07757867
Microneedling-Assisted Delivery of Cetirizine Versus Latanoprost in Alopecia Areata
A study testing Cetirizine (Zyrtec), Latanoprost and Triamcinolone Acetonide in people with Microneedling-Assisted Delivery and Cetirizine, run by Tanta University at 1 site in Egypt.
Trial summary
This study planned to measure the effectiveness and safety of microneedling aided administration of cetirizine 1% versus latanoprost 0.01% in alopecia areata. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Microneedling-Assisted Delivery, Cetirizine, Latanoprost
- What is being tested?
- Cetirizine (Zyrtec), Latanoprost and Triamcinolone Acetonide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2022to 1 Oct 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Newly diagnosed cases of alopecia areata.
- Patients of any age.
- Both male and female patients.
- Recent-onset patchy alopecia areata of ≤6 months' duration.
- Presence of no more than two alopecia patches.
- Stationary course of the disease.
- Willingness to participate in the study.
- Provision of written informed consent or parental/guardian consent for minors.
Who cannot join
- Extensive alopecia areata, including alopecia totalis or alopecia universalis.
- Previous treatment of the alopecia areata lesions.
- Active scalp infection.
- Presence of associated dermatological, systemic, or autoimmune comorbidities.
- Known allergy or hypersensitivity to any of the planned therapeutic agents.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Microneedling-Assisted Delivery of Cetirizine Versus Latanoprost in Alopecia Areata: A Pilot Randomized Controlled Study
This study planned to measure the effectiveness and safety of microneedling aided administration of cetirizine 1% versus latanoprost 0.01% in alopecia areata.
Read the detailed description
Alopecia areata (AA) is a chronic inflammatory disease affecting the hair follicles with a possible multifactorial origin, most prominently in genetically predisposed patients. It is a common cause of non scarring hair loss that presents in a patchy, confluent, or diffuse pattern. The onset may be at any age and there is no known race or sex preponderance.
The treatment of AA depends on the severity and extent of the disease. Treatment options include topical or intralesional corticosteroids, phototherapy, topical irritants, topical minoxidil, topical tacrolimus, topical vitamin D analogs and platelet rich plasma injection. For resistant cases, psoralen with ultraviolet A light, oral cyclosporine and other immunosuppressants could be beneficial.
Microneedling therapy is becoming popular in management of acne scars and also for facial rejuvenations. Recently it has been shown to stimulate hair growth. The proposed mechanism of action is thought to be stimulation of dermal papilla and stem cells and also increasing the blood supply to the hair follicles.
Scalp microneedling is a minimally invasive procedure in which various micro-channels are created by short fine needles to help in penetration and absorption of various agents into the skin. So, microneedling is a promising and effective therapy for the treatment of AA
- Being tested
- Cetirizine (Zyrtec), Latanoprost, Triamcinolone Acetonide, Microneedling only
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetirizine (Zyrtec)Drug
Patinets treated with microneedling-aided administration of topical cetirizine 1% solution
LatanoprostDrug
Patients treated with microneedling-aided administration of topical triamcinolone acetonide (TrA) (10mg/ml) as a positive control group
Triamcinolone AcetonideDrug
Patients treated with microneedling-aided administration of topical triamcinolone acetonide (TrA) (10mg/ml) as a positive control group
Microneedling onlyProcedure or surgery
Patientstreated with microneedling only as a negative control group
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Patients treated with microneedling-aided administration of topical cetirizine 1% solution. Receives: Drug: Cetirizine (Zyrtec) |
| Group B | Experimental | Patients treated with microneedling-aided administration of topical latanoprost 0.01% solution. Receives: Drug: Latanoprost |
| group C | Active comparator | Patients treated with microneedling-aided administration of topical triamcinolone acetonide (TrA) (10mg/ml) as a positive control group Receives: Drug: Triamcinolone Acetonide |
| Group D | Active comparator | Patients treated with microneedling only as a negative control group Receives: Procedure: Microneedling only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of Alopecia Tool Score (SALT Score)
The Severity of Alopecia Tool (SALT) score was used to assess the extent of scalp hair loss. The score ranges from 0 to 100, with higher scores indicating greater scalp hair loss. Changes in SALT score from baseline was compared between the treatment groups.
Measured: Baseline and 12 weeks
Secondary outcomes (2)
Global assessment of hair regrowth
Hair regrowth was evaluated by the investigator using standardized clinical photographs and a global assessment scale. The degree of hair regrowth was graded on a 5-point scale ranging from 0 (no regrowth) to 4 (excellent regrowth, ≥75%), with higher scores indicating greater clinical improvement. Assessments were performed at baseline and at the end of the 12-week treatment period.
Measured: Baseline and at the end of the 12-week treatment period
Adverse events
Complications, including pain, erythema, edema, pruritus, infection, post-inflammatory hyperpigmentation, allergic reactions, and any other local or systemic adverse events
Measured: Throughout the 12-week study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start1 Oct 2022
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microneedling-Assisted DeliveryStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yomna Mazid El-Hamd Neinaa, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07757867
- Sponsor's protocol ID
- 35668/8/22
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microneedling-Assisted Delivery of Cetirizine Versus Latanoprost in Alopecia Areata: A Pilot Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07757867
- Acronym / sponsor ID
- 35668/8/22
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 11 Aug 2026 (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.
This study planned to measure the effectiveness and safety of microneedling aided administration of cetirizine 1% versus latanoprost 0.01% in alopecia areata.
Detailed description
Alopecia areata (AA) is a chronic inflammatory disease affecting the hair follicles with a possible multifactorial origin, most prominently in genetically predisposed patients. It is a common cause of non scarring hair loss that presents in a patchy, confluent, or diffuse pattern. The onset may be at any age and there is no known race or sex preponderance.
The treatment of AA depends on the severity and extent of the disease. Treatment options include topical or intralesional corticosteroids, phototherapy, topical irritants, topical minoxidil, topical tacrolimus, topical vitamin D analogs and platelet rich plasma injection. For resistant cases, psoralen with ultraviolet A light, oral cyclosporine and other immunosuppressants could be beneficial.
Microneedling therapy is becoming popular in management of acne scars and also for facial rejuvenations. Recently it has been shown to stimulate hair growth. The proposed mechanism of action is thought to be stimulation of dermal papilla and stem cells and also increasing the blood supply to the hair follicles.
Scalp microneedling is a minimally invasive procedure in which various micro-channels are created by short fine needles to help in penetration and absorption of various agents into the skin. So, microneedling is a promising and effective therapy for the treatment of AA
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Cetirizine (Zyrtec)Patients treated with microneedling-aided administration of topical cetirizine 1% solution. |
| Group B | Experimental | Drug: LatanoprostPatients treated with microneedling-aided administration of topical latanoprost 0.01% solution. |
| group C | Active comparator | Drug: Triamcinolone AcetonidePatients treated with microneedling-aided administration of topical triamcinolone acetonide (TrA) (10mg/ml) as a positive control group |
| Group D | Active comparator | Procedure: Microneedling onlyPatients treated with microneedling only as a negative control group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Newly diagnosed cases of alopecia areata.
- Patients of any age.
- Both male and female patients.
- Recent-onset patchy alopecia areata of ≤6 months' duration.
- Presence of no more than two alopecia patches.
Key exclusion criteria (5 listed)
- Extensive alopecia areata, including alopecia totalis or alopecia universalis.
- Previous treatment of the alopecia areata lesions.
- Active scalp infection.
- Presence of associated dermatological, systemic, or autoimmune comorbidities.
- Known allergy or hypersensitivity to any of the planned therapeutic agents.
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 |
|---|---|---|
| Cetirizine (Zyrtec)Patinets treated with microneedling-aided administration of topical cetirizine 1% solution | Drug | Group A |
| LatanoprostPatients treated with microneedling-aided administration of topical triamcinolone acetonide (TrA) (10mg/ml) as a positive control group | Drug | Group B |
| Triamcinolone AcetonidePatients treated with microneedling-aided administration of topical triamcinolone acetonide (TrA) (10mg/ml) as a positive control group | Drug | group C |
| Microneedling onlyPatientstreated with microneedling only as a negative control group | Procedure or surgery | Group D |
Primary outcome
Severity of Alopecia Tool Score (SALT Score)
Time frame: Baseline and 12 weeks
The Severity of Alopecia Tool (SALT) score was used to assess the extent of scalp hair loss. The score ranges from 0 to 100, with higher scores indicating greater scalp hair loss. Changes in SALT score from baseline was compared between the treatment groups.
2 secondary outcomes
Global assessment of hair regrowth
Time frame: Baseline and at the end of the 12-week treatment period
Adverse events
Time frame: Throughout the 12-week study period.
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 11 Aug 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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 Cetirizine (Zyrtec), Latanoprost and Triamcinolone Acetonide in people with Microneedling-Assisted Delivery and Cetirizine, run by Tanta University 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 8 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: finished, as of the sponsor's last update on 11 Aug 2026. 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.
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?
Severity of Alopecia Tool Score (SALT Score) (time frame: Baseline and 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 11 Aug 2026.