Alopecia AreataPhase 4NCT04003376
Efficacy of Fractional CO2 Laser as a Mono- or Adjuvant Therapy for Alopecia Areata
A Phase 4 study testing fractional carbon dioxide laser alone, Triamcinolone Acetonide 10mg/mL and platelet rich plasma in people with Alopecia Areata, run by Assiut University at 1 site in Egypt.
Trial summary
Alopecia areata is a non-scarring hair loss disorder that affects both sexes equally. Incidence of the disease varies for different populations and in different studies, with global incidence ranging from 0.57% to 3.8%. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- fractional carbon dioxide laser alone, Triamcinolone Acetonide 10mg/mL and platelet rich plasma
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Jul 2019to 1 Jul 2022
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with refractory alopecia areata above 10 years old
Who cannot join
- Alopecia totalis or alopecia universalis.
- Patients with alopecia other than alopecia areata.
- Patients younger than 10 years.
- Pregnant and lactating females.
- Patients with history of hypertrophic scars or keloid formation.
- Patients with active infection at the site of the lesion.
- Patients with blood disorders and platelet abnormalities and chronic liver disease.
- Patients using anticoagulation therapy and antiplatelet agents.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University Hospital
Asyut
Alaa Ghazally, MS, 01007224787, alaaghazally@yahoo.com
About this study
Official title: Efficacy of Fractional CO2 Laser Alone and as Transepidermal Drug Delivery for Different Modalities of Treatment in Alopecia Areata
Alopecia areata is a non-scarring hair loss disorder that affects both sexes equally. Incidence of the disease varies for different populations and in different studies, with global incidence ranging from 0.57% to 3.8%.
Etiology of alopecia areata is not completely understood, and the majority of evidence suggests that genetically predisposed individuals, when exposed to an unknown trigger, develop a predominantly autoimmune reaction, leading to acute hair loss. Environmental triggers, including viral or bacterial infections, along with autoimmune disorders, seem to play a major role in the development of alopecia areata.
Read the detailed description
The onset and progression of alopecia areata are unpredictable. Significant variations in the clinical presentation of alopecia areata have been observed, ranging from small, well-circumscribed patches of hair loss to a complete absence of body and scalp hair.
Although many patients improve spontaneously or respond to standard therapy, treatment can be quite challenging in those with more severe and refractory disease.
Recent advances in the understanding of alopecia areata pathophysiology hold promise for better treatments in the future.
Corticosteroids either topical or intralesional are the most popular drugs for the treatment of this disease. Other therapies like topical minoxidil, anthralin, immunotherapy, systemic corticosteroids, cyclosporine and Psoralen with Ultraviolet-A Light therapy are also commonly used with varying success.
Various lasers have been suggested in recent studies to treat alopecia areata . The effect of 308-nm excimer laser was the most studied, while others, including neodymium-doped yttrium aluminum garnet, erbium:glass laser, fractional carbon dioxide laser, and low-level laser therapy, have also been assessed.
Despite the nascent state of research on lasers as a treatment option for alopecia areata , there have been a great deal of promising results. It is possible for lasers to become the mainstay treatment option of alopecia areata .
It was suggested that ablative fractional lasers may exert its effect through: induction of moderate inflammation to promote anagen entry and creation of channel pathways for topically applied medications they grant access to dermal structures such as hair follicles and cutaneous vasculature. Also, creation of a wound by the ablative fractional laser may stimulate stem cell populations to produce a hair shaft and progress through all stages of the hair follicle cycle.
Majid et al, investigated the efficacy and safety of the combination of fractional carbon dioxide followed by topical triamcinolone acetonide application in ten patients with resistant alopecia areata. Only eight patients completed the study. Seven of them had complete recovery of the treated area. One patient however did not show good response. No significant adverse effects were noted in any of the patients.
The role of platelet rich plasma in promoting hair survival and growth has been demonstrated both in vitro and in vivo. The activation of platelet α granules releases numerous growth factors, including transforming growth factor , platelet derived growth factor, vascular endothelial growth factor, epidermal growth factor, insulin-like growth factor, and interleukin-1. It is proposed that these growth factors may act on stem cells in the bulge area of the follicles, stimulating the development of new follicles and promoting neovascularization. platelet rich plasma has been found to benefit in hair growth in alopecia areata. Intralesional injections of platelet rich plasma were found to increase hair regrowth significantly compared with triamcinolone acetonide or placebo.
Vitamin D 1, 25-dihydroxycholecalciferol [1, 25(OH)/2 D3] is the biologic active form of the vitamin D3. Vitamin D has a multitude of biologic effects interacting with the innate and adaptive immune system, mainly leading to its downregulation. It regulates the differentiation of B cells, T cells, dendritic cells, and the expression of Toll-like receptors. There is growing evidence that vitamin D may help in several autoimmune diseases like multiple sclerosis and type I diabetes mellitus, lupus, and rheumatoid arthritis.
The relation between vitamin D levels and the development of alopecia areata and whether vitamin D supplementation helps in the treatment of alopecia areata represent an attractive area of research. Recent studies suggest that there is deficiency of serum vitamin D and reduced vitamin D receptor expression in the affected hair follicles in alopecia areata patients, the results of which may prove that vitamin D is a safe and helpful choice in alopecia areata treatment.
To the best our knowledge no previous research studied the effect of vitamin D solution in treatment of alopecia areata.
- Conditions
- Alopecia Areata
- Being tested
- fractional carbon dioxide laser alone, Triamcinolone Acetonide 10mg/mL, platelet rich plasma, vitamin D solution
- Keywords
- fractional carbon dioxide laser
- 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 carbon dioxide laser aloneDevice
six sessions of fractional carbon dioxide laser will be done for alopecia areata lesions
Triamcinolone Acetonide 10mg/mLDrug
six sessions of fractional carbon dioxide laser will be done for 10 patients with alopecia areata followed immediately by topical application of triamcinolone acetonide
platelet rich plasmaBiological
six sessions of fractional carbon dioxide laser will be done for 10 patients with alopecia areata followed immediately by topical application of autologous platelet rich plasma
vitamin D solutionDrug
six sessions of fractional carbon dioxide laser will be done for 10 patients with alopecia areata followed immediately by topical application of vitamin D solution
| Study group | Role | What they receive |
|---|---|---|
| fractional carbon dioxide laser alone | Active comparator | six sessions of fractional carbon dioxide laser will be done for 10 patients with alopecia areata Receives: Device: fractional carbon dioxide laser alone |
| fractional carbon dioxide laser and triamcinolone acetonide | Experimental | six sessions of fractional carbon dioxide laser will be done for 10 patients with alopecia areata followed immediately by topical application of triamcinolone acetonide (10mg/ml) Receives: Device: fractional carbon dioxide laser alone; Drug: Triamcinolone Acetonide 10mg/mL |
| fractional carbon dioxide laser and platelet rich plasma | Experimental | six sessions of fractional carbon dioxide laser will be done for 10 patients with alopecia areata followed immediately by topical application of autologous platelet rich plasma Receives: Device: fractional carbon dioxide laser alone; Biological: platelet rich plasma |
| fractional carbon dioxide laser and vitamin D solution | Experimental | six sessions of fractional carbon dioxide laser will be done for 10 patients with alopecia areata followed immediately by topical application of vitamin D solution Receives: Device: fractional carbon dioxide laser alone; Drug: vitamin D solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate
hair regrowth in each group in response to treatment (hair density ) expressed in follicles/ cm2
Measured: 3 months after last session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start26 Jul 2019
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A Ghazally, Assiut University
- Investigators
- Alaa Ghazally, MS, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04003376
- Sponsor's protocol ID
- CO2LASERAA
- Status last verified
- May 2020
- First submitted
- 27 Jun 2019
- Last updated
- 19 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aksu Cerman A, Sarikaya Solak S, Kivanc Altunay I. Vitamin D deficiency in alopecia areata. Br J Dermatol. 2014 Jun;170(6):1299-304. doi: 10.1111/bjd.12980.
PubMed 24655364Alkhalifah A, Alsantali A, Wang E, McElwee KJ, Shapiro J. Alopecia areata update: part II. Treatment. J Am Acad Dermatol. 2010 Feb;62(2):191-202, quiz 203-4. doi: 10.1016/j.jaad.2009.10.031.
PubMed 20115946Huang Y, Zhuo F, Li L. Enhancing hair growth in male androgenetic alopecia by a combination of fractional CO2 laser therapy and hair growth factors. Lasers Med Sci. 2017 Nov;32(8):1711-1718. doi: 10.1007/s10103-017-2232-8. Epub 2017 May 21.
PubMed 28528395Issa MC, Pires M, Silveira P, Xavier de Brito E, Sasajima C. Transepidermal drug delivery: a new treatment option for areata alopecia? J Cosmet Laser Ther. 2015 Feb;17(1):37-40. doi: 10.3109/14764172.2014.967778. Epub 2014 Oct 16.
PubMed 25260052
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Fractional CO2 Laser Alone and as Transepidermal Drug Delivery for Different Modalities of Treatment in Alopecia Areata
- ClinicalTrials.gov ID
- NCT04003376
- Acronym / sponsor ID
- CO2LASERAA
- Conditions
- Alopecia Areata
- Keywords
- fractional carbon dioxide laser
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 26 Jul 2019 (actual)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 1 Jul 2019 (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 is a non-scarring hair loss disorder that affects both sexes equally. Incidence of the disease varies for different populations and in different studies, with global incidence ranging from 0.57% to 3.8%.
Etiology of alopecia areata is not completely understood, and the majority of evidence suggests that genetically predisposed individuals, when exposed to an unknown trigger, develop a predominantly autoimmune reaction, leading to acute hair loss. Environmental triggers, including viral or bacterial infections, along with autoimmune disorders, seem to play a major role in the development of alopecia areata.
Detailed description
The onset and progression of alopecia areata are unpredictable. Significant variations in the clinical presentation of alopecia areata have been observed, ranging from small, well-circumscribed patches of hair loss to a complete absence of body and scalp hair.
Although many patients improve spontaneously or respond to standard therapy, treatment can be quite challenging in those with more severe and refractory disease.
Recent advances in the understanding of alopecia areata pathophysiology hold promise for better treatments in the future.
Corticosteroids either topical or intralesional are the most popular drugs for the treatment of this disease. Other therapies like topical minoxidil, anthralin, immunotherapy, systemic corticosteroids, cyclosporine and Psoralen with Ultraviolet-A Light therapy are also commonly used with varying success.
Various lasers have been suggested in recent studies to treat alopecia areata . The effect of 308-nm excimer laser was the most studied, while others, including neodymium-doped yttrium aluminum garnet, erbium:glass laser, fractional carbon dioxide laser, and low-level laser therapy, have also been assessed.
Despite the nascent state of research on lasers as a treatment option for alopecia areata , there have been a great deal of promising results. It is possible for lasers to become the mainstay treatment option of alopecia areata .
It was suggested that ablative fractional lasers may exert its effect through: induction of moderate inflammation to promote anagen entry and creation of channel pathways for topically applied medications they grant access to dermal structures such as hair follicles and cutaneous vasculature. Also, creation of a wound by the ablative fractional laser may stimulate stem cell populations to produce a hair shaft and progress through all stages of the hair follicle cycle.
Majid et al, investigated the efficacy and safety of the combination of fractional carbon dioxide followed by topical triamcinolone acetonide application in ten patients with resistant alopecia areata. Only eight patients completed the study. Seven of them had complete recovery of the treated area. One patient however did not show good response. No significant adverse effects were noted in any of the patients.
The role of platelet rich plasma in promoting hair survival and growth has been demonstrated both in vitro and in vivo. The activation of platelet α granules releases numerous growth factors, including transforming growth factor , platelet derived growth factor, vascular endothelial growth factor, epidermal growth factor, insulin-like growth factor, and interleukin-1. It is proposed that these growth factors may act on stem cells in the bulge area of the follicles, stimulating the development of new follicles and promoting neovascularization. platelet rich plasma has been found to benefit in hair growth in alopecia areata. Intralesional injections of platelet rich plasma were found to increase hair regrowth significantly compared with triamcinolone acetonide or placebo.
Vitamin D 1, 25-dihydroxycholecalciferol [1, 25(OH)/2 D3] is the biologic active form of the vitamin D3. Vitamin D has a multitude of biologic effects interacting with the innate and adaptive immune system, mainly leading to its downregulation. It regulates the differentiation of B cells, T cells, dendritic cells, and the expression of Toll-like receptors. There is growing evidence that vitamin D may help in several autoimmune diseases like multiple sclerosis and type I diabetes mellitus, lupus, and rheumatoid arthritis.
The relation between vitamin D levels and the development of alopecia areata and whether vitamin D supplementation helps in the treatment of alopecia areata represent an attractive area of research. Recent studies suggest that there is deficiency of serum vitamin D and reduced vitamin D receptor expression in the affected hair follicles in alopecia areata patients, the results of which may prove that vitamin D is a safe and helpful choice in alopecia areata treatment.
To the best our knowledge no previous research studied the effect of vitamin D solution in treatment of alopecia areata.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| fractional carbon dioxide laser alone | Active comparator | Device: fractional carbon dioxide laser alonesix sessions of fractional carbon dioxide laser will be done for 10 patients with alopecia areata |
| fractional carbon dioxide laser and triamcinolone acetonide | Experimental | Device: fractional carbon dioxide laser alone, Drug: Triamcinolone Acetonide 10mg/mLsix sessions of fractional carbon dioxide laser will be done for 10 patients with alopecia areata followed immediately by topical application of triamcinolone acetonide (10mg/ml) |
| fractional carbon dioxide laser and platelet rich plasma | Experimental | Device: fractional carbon dioxide laser alone, Biological: platelet rich plasmasix sessions of fractional carbon dioxide laser will be done for 10 patients with alopecia areata followed immediately by topical application of autologous platelet rich plasma |
| fractional carbon dioxide laser and vitamin D solution | Experimental | Device: fractional carbon dioxide laser alone, Drug: vitamin D solutionsix sessions of fractional carbon dioxide laser will be done for 10 patients with alopecia areata followed immediately by topical application of vitamin D solution |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients with refractory alopecia areata above 10 years old
Key exclusion criteria (8 listed)
- Alopecia totalis or alopecia universalis.
- Patients with alopecia other than alopecia areata.
- Patients younger than 10 years.
- Pregnant and lactating females.
- Patients with history of hypertrophic scars or keloid formation.
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 carbon dioxide laser alonesix sessions of fractional carbon dioxide laser will be done for alopecia areata lesions | Device | fractional carbon dioxide laser alone, fractional carbon dioxide laser and platelet rich plasma, fractional carbon dioxide laser and triamcinolone acetonide, fractional carbon dioxide laser and vitamin D solution |
| Triamcinolone Acetonide 10mg/mLsix sessions of fractional carbon dioxide laser will be done for 10 patients with alopecia areata followed immediately by topical application of triamcinolone acetonide | Drug | fractional carbon dioxide laser and triamcinolone acetonide |
| platelet rich plasmasix sessions of fractional carbon dioxide laser will be done for 10 patients with alopecia areata followed immediately by topical application of autologous platelet rich plasma | Biological | fractional carbon dioxide laser and platelet rich plasma |
| vitamin D solutionsix sessions of fractional carbon dioxide laser will be done for 10 patients with alopecia areata followed immediately by topical application of vitamin D solution | Drug | fractional carbon dioxide laser and vitamin D solution |
Primary outcome
response rate
Time frame: 3 months after last session
hair regrowth in each group in response to treatment (hair density ) expressed in follicles/ cm2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
- Background: PubMed 24655364Aksu Cerman A, Sarikaya Solak S, Kivanc Altunay I. Vitamin D deficiency in alopecia areata. Br J Dermatol. 2014 Jun;170(6):1299-304. doi: 10.1111/bjd.12980.
- Background: PubMed 20115946Alkhalifah A, Alsantali A, Wang E, McElwee KJ, Shapiro J. Alopecia areata update: part II. Treatment. J Am Acad Dermatol. 2010 Feb;62(2):191-202, quiz 203-4. doi: 10.1016/j.jaad.2009.10.031.
- Background: PubMed 28528395Huang Y, Zhuo F, Li L. Enhancing hair growth in male androgenetic alopecia by a combination of fractional CO2 laser therapy and hair growth factors. Lasers Med Sci. 2017 Nov;32(8):1711-1718. doi: 10.1007/s10103-017-2232-8. Epub 2017 May 21.
- Background: PubMed 25260052Issa MC, Pires M, Silveira P, Xavier de Brito E, Sasajima C. Transepidermal drug delivery: a new treatment option for areata alopecia? J Cosmet Laser Ther. 2015 Feb;17(1):37-40. doi: 10.3109/14764172.2014.967778. Epub 2014 Oct 16.
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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.
Alaa Ghazally, MS principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing fractional carbon dioxide laser alone, Triamcinolone Acetonide 10mg/mL and platelet rich plasma in people with Alopecia Areata, run by Assiut 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 1 inclusion and 8 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 19 May 2020. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Azza Mahfouz, PHD (01001801039, azzamahfouz@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response rate (time frame: 3 months after last session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04003376, which also lists 4 linked publications.
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 19 May 2020.