Alopecia AreataNCT05587257
Role of Minoxidil in Alopecia Areata Transepidermal Drug Delivery of Minoxidil Via Either Fractional Carbon Dioxide Laser or Microneedling Versus Its Topical Nanoparticles Preparation for Treatment of Alopecia Areata
A study testing Fractional CO2 laser, Derma pen and Niosome minoxidil in people with Alopecia Areata, run by Assiut University.
Trial summary
Compare the clinical efficacy, and safety of transepidermal drug delivery of fractional CO2 laser versus microneedling followed by minoxidil 5% application for the treatment of alopecia areata. Evaluate the efficacy, and safety of minoxidil nanoparticles as a topical treatment of alopecia areata. Read more about this study
- Who is it for?
- Ages 10 to 50 years
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- Fractional CO2 laser, Derma pen and Niosome minoxidil
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 1 Feb 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 10 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- The study will include patients with alopecia areata
Who cannot join
- Children below 18 years , pregnant and lactating women . patients with chronic hepatic, hematological disorders or immunocompromised patients.
- patient recieved any treatment for alopecia areata in the last 3 months before the study.
- patients with extensive types (alopecia totalis, universalis and surface area >50%).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Transepidermal Drug Delivery of Minoxidil Via Either Fractional Carbon Dioxide Laser or Microneedling Versus Its Topical Nanoparticles Preparation for Treatment of Alopecia Areata
- Compare the clinical efficacy, and safety of transepidermal drug delivery of fractional CO2 laser versus microneedling followed by minoxidil 5% application for the treatment of alopecia areata.
- Evaluate the efficacy, and safety of minoxidil nanoparticles as a topical treatment of alopecia areata.
Read the detailed description
Alopecia areata (AA) is the most common cause of non-scarring alopecia. (Hordinsky, 2013).
Although many patients improve spontaneously or respond to standard therapy, in patients with more severe and refractory disease, management can be quite challenging (Messenger et al., 2012 and Kranseler and Sidbury, 2017).
Corticosteroids either topical or intralesional are the most popular medications used to treat this condition. Other therapies such as topical minoxidil (MXD), anthralin, immunotherapy, systemic corticosteroids are also commonly used with variable success (Shumez et al., 2015).
Patients treated with MXD 5% have significant hair growth than placebo. Minoxidil was more effective for patchy alopecia than other types of AA such as ophiasis and alopecia totalis. It was ineffective in alopecia universalis (El-Taib et al., 2017).
In contrast, the incidence of adverse events associated with 10% MXD treatment was higher than with 5% MXD treatment. Therefore, new approaches are required to achieve both expected efficacy and safety (Oaku et al., 2022).
The combination of non-ablative laser and topical MXD can be a good alternative therapy for AA patients, including alopecia totalis and alopecia universalis, without systemic and local side effects (Wang et al., 2019) According to follicle deposition and diffusion experiments, minoxidil nanoemulsions penetrated hair follicles 26 times more efficiently than standard treatment (Cardoso and Barradas, 2020).
To the best our knowledge no previous research studied the effect of nanominoxidil solution in treatment of AA except in animal or compare transepidermal drug delivery versus topical nanominoxidil.
- Conditions
- Alopecia Areata
- Being tested
- Fractional CO2 laser, Derma pen, Niosome minoxidil, Minoxidil Topical Spray
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional CO2 laserDevice
Also called Drug
Each patient will receive 6 sessions 2 weeks apart, after the laser treatment, a topical 5% minoxidil tincture will immediately applied.
All patients will advised not to use any other treatment during the study
Derma penDevice
Also called Drug
, will be treated by microneedling using dermapen ( automated Derma Pen, DR Pen Ultima A6, China) which under complete aseptic precaution with a cartridge containing 12 needles moved diagonally, vertically, and horizontally for 4-5 times in each direction with 1.5 mm depth and speed 4-5(new cartridge every session), the application has been extended 1-2 cm perilesionally. The pinpoint bleeding will be considered an endpoint. topical 5% minoxidil tincture will immediately applied. Each patient will receive 6 sessions 2 weeks apart.
Niosome minoxidilDrug
The patient of alopecia areata will be treated by topical nanominoxidil preparation twice daily for 3 months with no other treatment.
Minoxidil Topical SprayDrug
The patient of alopecia areata will be treated by topical minoxidil 5% preparation twice daily for 3 months with no other treatment.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | six sessions of fractional carbon dioxide laser every 2 weeks will be done for 15 patients with alopecia areata followed immediately by topical application of minoxidil 5% Receives: Device: Fractional CO2 laser |
| Group 2 | Experimental | six sessions of microneedling evry 2 weeks will be done for 15 patients with alopecia areata followed immediately by topical application of minoxidil 5% Receives: Device: Derma pen |
| Group 3 | Experimental | 15 patient of alopecia areata that will be treated by topical nanominoxidil for 3 months. Receives: Drug: Niosome minoxidil |
| Group 4 | Active comparator | 15 patient of alopecia areata that will be treated by topical minoxidil 5% for 3 months Receives: Drug: Minoxidil Topical Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regrowth scale
0 score (regrowth < 10%) no response
score (regrowth 11-25%) poor response score (regrowth 26-50%) fair response score (regrowth 51-75%) satisfactory response score (regrowth ≥ 75%) excellent response
Measured: 6 months
Mcdonald Hull and Norris Regrowth Scale (by trichoscope
Grade 1 - Regrowth of vellus hair. Grade 2 - Regrowth of sparse pigmented terminal hair. Grade 3 - Regrowth of terminal hair with patches of alopecia with patches of alopecia 50-75% in SALT score.
Grade 4 - Regrowth of terminal hair on scalp with patches of alopecia > 75% in SALT score.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start1 Jan 2023 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Feb 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.
- More trials run by Assiut 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Elsayed Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05587257
- Sponsor's protocol ID
- Minoxidil in alopecia areata
- Status last verified
- Oct 2022
- First submitted
- 16 Oct 2022
- Last updated
- 20 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transepidermal Drug Delivery of Minoxidil Via Either Fractional Carbon Dioxide Laser or Microneedling Versus Its Topical Nanoparticles Preparation for Treatment of Alopecia Areata
- ClinicalTrials.gov ID
- NCT05587257
- Acronym / sponsor ID
- Minoxidil in alopecia areata
- Conditions
- Alopecia Areata
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 20 Oct 2022 (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.
- Compare the clinical efficacy, and safety of transepidermal drug delivery of fractional CO2 laser versus microneedling followed by minoxidil 5% application for the treatment of alopecia areata.
- Evaluate the efficacy, and safety of minoxidil nanoparticles as a topical treatment of alopecia areata.
Detailed description
Alopecia areata (AA) is the most common cause of non-scarring alopecia. (Hordinsky, 2013).
Although many patients improve spontaneously or respond to standard therapy, in patients with more severe and refractory disease, management can be quite challenging (Messenger et al., 2012 and Kranseler and Sidbury, 2017).
Corticosteroids either topical or intralesional are the most popular medications used to treat this condition. Other therapies such as topical minoxidil (MXD), anthralin, immunotherapy, systemic corticosteroids are also commonly used with variable success (Shumez et al., 2015).
Patients treated with MXD 5% have significant hair growth than placebo. Minoxidil was more effective for patchy alopecia than other types of AA such as ophiasis and alopecia totalis. It was ineffective in alopecia universalis (El-Taib et al., 2017).
In contrast, the incidence of adverse events associated with 10% MXD treatment was higher than with 5% MXD treatment. Therefore, new approaches are required to achieve both expected efficacy and safety (Oaku et al., 2022).
The combination of non-ablative laser and topical MXD can be a good alternative therapy for AA patients, including alopecia totalis and alopecia universalis, without systemic and local side effects (Wang et al., 2019) According to follicle deposition and diffusion experiments, minoxidil nanoemulsions penetrated hair follicles 26 times more efficiently than standard treatment (Cardoso and Barradas, 2020).
To the best our knowledge no previous research studied the effect of nanominoxidil solution in treatment of AA except in animal or compare transepidermal drug delivery versus topical nanominoxidil.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: Fractional CO2 lasersix sessions of fractional carbon dioxide laser every 2 weeks will be done for 15 patients with alopecia areata followed immediately by topical application of minoxidil 5% |
| Group 2 | Experimental | Device: Derma pensix sessions of microneedling evry 2 weeks will be done for 15 patients with alopecia areata followed immediately by topical application of minoxidil 5% |
| Group 3 | Experimental | Drug: Niosome minoxidil15 patient of alopecia areata that will be treated by topical nanominoxidil for 3 months. |
| Group 4 | Active comparator | Drug: Minoxidil Topical Spray15 patient of alopecia areata that will be treated by topical minoxidil 5% for 3 months |
Who may qualify
- Ages
- 10 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- The study will include patients with alopecia areata
Key exclusion criteria (3 listed)
- Children below 18 years , pregnant and lactating women . patients with chronic hepatic, hematological disorders or immunocompromised patients.
- patient recieved any treatment for alopecia areata in the last 3 months before the study.
- patients with extensive types (alopecia totalis, universalis and surface area >50%).
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 |
|---|---|---|
| Fractional CO2 laserAlso: DrugEach patient will receive 6 sessions 2 weeks apart, after the laser treatment, a topical 5% minoxidil tincture will immediately applied. All patients will advised not to use any other treatment during the study | Device | Group 1 |
| Derma penAlso: Drug, will be treated by microneedling using dermapen ( automated Derma Pen, DR Pen Ultima A6, China) which under complete aseptic precaution with a cartridge containing 12 needles moved diagonally, vertically, and horizontally for 4-5 times in each direction with 1.5 mm depth and speed 4-5(new cartridge every session), the application has been extended 1-2 cm perilesionally. The pinpoint bleeding will be considered an endpoint. topical 5% minoxidil tincture will immediately applied. Each patient will receive 6 sessions 2 weeks apart. | Device | Group 2 |
| Niosome minoxidilThe patient of alopecia areata will be treated by topical nanominoxidil preparation twice daily for 3 months with no other treatment. | Drug | Group 3 |
| Minoxidil Topical SprayThe patient of alopecia areata will be treated by topical minoxidil 5% preparation twice daily for 3 months with no other treatment. | Drug | Group 4 |
Primary outcome
Regrowth scale
Time frame: 6 months
0 score (regrowth < 10%) no response score (regrowth 11-25%) poor response score (regrowth 26-50%) fair response score (regrowth 51-75%) satisfactory response score (regrowth ≥ 75%) excellent response
Mcdonald Hull and Norris Regrowth Scale (by trichoscope
Time frame: 6 months
Grade 1 - Regrowth of vellus hair. Grade 2 - Regrowth of sparse pigmented terminal hair. Grade 3 - Regrowth of terminal hair with patches of alopecia with patches of alopecia 50-75% in SALT score. Grade 4 - Regrowth of terminal hair on scalp with patches of alopecia > 75% in SALT score.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2022.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Fractional CO2 laser, Derma pen and Niosome minoxidil in people with Alopecia Areata, run by Assiut University.
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 3 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 20 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Elsayed, Master (+20 1000520295, Ahmed.alsaid@med.aun.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regrowth scale (time frame: 6 months). The study lists 2 primary outcomes in all. 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 20 Oct 2022.