Alopecia AreataNCT05954104
Evaluation of the Effect of Topical Calcipotriol Versus Platelet-Rich Plasma
A study testing Calcipotriol in people with Alopecia Areata, run by Egymedicalpedia at 1 site in Egypt.
Trial summary
Alopecia areata (AA) is a common, immune-mediated non scarring alopecia and can be associated with severe psychological consequences . Alopecia Areata affects 2% of the global population. Alopecia Areata prevalence is lower in adults than children, is increasing over time, and significantly differs by region. Read more about this study
- Who is it for?
- Ages 5 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- Calcipotriol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2023to 15 Oct 2023
- 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 5 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients with non-severe alopecia areata , a severity of alopecia tool (SALT) score up to 2 with less than 50% of scalp involvement.
- No restriction of age , race, nor occupation
Who cannot join
- Pregnant and lactating women, immunocompromised patients.
- Patients having active scalp inflammation.
- Patients who received systemic treatment for Alopecia Areata in the last 3 months or applied any topical or intradermal treatments in the last 4 weeks .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Topical Calcipotriol Versus Platelet-Rich Plasma Versus Combined of Both on Serum Adiponectin Level in Alopecia Areata
Alopecia areata (AA) is a common, immune-mediated non scarring alopecia and can be associated with severe psychological consequences . Alopecia Areata affects 2% of the global population. Alopecia Areata prevalence is lower in adults than children, is increasing over time, and significantly differs by region.
Its etiology is unknown but it was hypothesized to be an autoimmune disease mediated by T-lymphocytes. It has been suggested that inflammatory T cells induce growth arrest in hair bulbs in the anagen phase of the hair cycle . Cytotoxic T cells secrete tumor necrosis factor, granzymes, and Fas ligand which trigger apoptosis in affected hair follicle and disrupt hair growth
Read the detailed description
Clinically, Alopecia Areata presents as a well-circumscribed patch of sudden hair loss. It affects any hair bearing area. The most common affected site is the scalp .
Dermoscopy is a highly valuable tool in diagnosis and follow-up of Alopecia Areata. The most common trichoscopic features of Alopecia Areata are yellow dots, micro exclamation mark hairs, tapered hairs, black dots, broken hairs, and regrowing upright or regrowing coiled hairs .
The diagnosis of alopecia areata is commonly established based on clinical appearance, In cases of ambiguity, trichoscopy may be useful to avoid invasive procedures such as biopsy.
Treatment of alopecia areata is dependent on age of patient as well as the extent and duration of scalp involvement. Treatments include steroids, topical immunotherapy, topical minoxidil, anthralin, and immunosuppressants. Each case must be dealt with on a customized individual basis.
Platelets rich plasma (PRP) is an autologous preparation of platelets in concentrated plasma. Injection of PRP improves cutaneous ischemic conditions, increases vascular structures around hair follicles and induces the proliferation of dermal papilla cells by up regulating fibroblast growth factor 7 (FGF-7) .Anagen-associated angiogenesis has been suggested as one of the important factors in active hair growth, due to the secretion of vascular endothelial growth factor by the keratinocytes of the outer root sheath and fibroblasts of the dermal papilla .
Topical calcipotriol is a vitamin D analogue that regulates keratinocytes proliferation and differentiation. It can induce hair regrowth in Alopecia Areata lesions by regulation of the differentiation of B cells, T cells, dendritic cells, and Toll-like receptor expression. There are few reports evaluating the effect of calcipotriol in Alopecia Areata .
Patients with Alopecia Areata are characterized by an abnormal serum level of adipokines, particularly adiponectin and resistin. Adiponectin may be considered as a marker of severity of hair loss in alopecia areata. Impaired secretion of specific adipokines may play an important and complex role in the pathogenesis of Alopecia Areata and its continuity
- Conditions
- Alopecia Areata
- Being tested
- Calcipotriol
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalcipotriolDrug
Also called Platelet Rich Plasma
To evaluate the efficacy of Calcipotriol on Alopecia Areata.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | About 20 patients suffering from Alopecia areata , they will receive topical vit D3 analogue (calcipotriol) 0.005% twice daily for 3 months with follow up Receives: Drug: Calcipotriol |
| Group B | Active comparator | About 20 patients suffering from Alopecia areata , they will be injected by PRP intra lesional for 3 consecutive sessions 4weeks apart. Receives: Drug: Calcipotriol |
| Group C | Active comparator | About 20 patients suffering from Alopecia areata they will receive combined therapy ( PRP and topical vit D3 analogue). Receives: Drug: Calcipotriol |
| Group D | Active comparator | About 20 of Healthy control group . Receives: Drug: Calcipotriol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of topical calcipotriol and platelet Rich Plasma in Alopecia Areata treatment
Evaluating the patients suffering from Alopecia Areata clinically, with Severity of Alopecia Tool (SALT) score. As score of 0 means no hair loss, while a SALT score of 100 is complete hair loss. and this evaluation will be done by trichoscopy
Measured: from baseline to 3 months
Secondary outcomes (2)
serum adiponectin level.
Compare the effect of topical calcipotriol, PRP, and combination of both on serum adiponectin level.by doing the ELISA test for Alopecia Areata patients before treatment and 3 months after treatment
Measured: from baseline to 3 months
serum Adiponectin level in Alopecia Areata
Compare serum adiponectin level in Alopecia Areata patients with its serum level in healthy control group.by doing the ELISA test for Alopecia Areata patients before treatment and for healthy control group.
Measured: from baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start1 Jul 2023
- Primary completion1 Oct 2023
- Study completion15 Oct 2023
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egymedicalpedia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Moustafa Adam, Professor, Study chair, Department of dermatology , Venerolgy and Andrology Faculty of Medicine Aswan university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05954104
- Sponsor's protocol ID
- Faten Othman
- Status last verified
- Oct 2023
- First submitted
- 23 Jun 2023
- Last updated
- 19 Oct 2023
- 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 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Topical Calcipotriol Versus Platelet-Rich Plasma Versus Combined of Both on Serum Adiponectin Level in Alopecia Areata
- ClinicalTrials.gov ID
- NCT05954104
- Acronym / sponsor ID
- Faten Othman
- Conditions
- Alopecia Areata
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- EgymedicalpediaIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 15 Oct 2023 (actual)
- First posted
- 20 Jul 2023 (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) is a common, immune-mediated non scarring alopecia and can be associated with severe psychological consequences . Alopecia Areata affects 2% of the global population. Alopecia Areata prevalence is lower in adults than children, is increasing over time, and significantly differs by region.
Its etiology is unknown but it was hypothesized to be an autoimmune disease mediated by T-lymphocytes. It has been suggested that inflammatory T cells induce growth arrest in hair bulbs in the anagen phase of the hair cycle . Cytotoxic T cells secrete tumor necrosis factor, granzymes, and Fas ligand which trigger apoptosis in affected hair follicle and disrupt hair growth
Detailed description
Clinically, Alopecia Areata presents as a well-circumscribed patch of sudden hair loss. It affects any hair bearing area. The most common affected site is the scalp .
Dermoscopy is a highly valuable tool in diagnosis and follow-up of Alopecia Areata. The most common trichoscopic features of Alopecia Areata are yellow dots, micro exclamation mark hairs, tapered hairs, black dots, broken hairs, and regrowing upright or regrowing coiled hairs .
The diagnosis of alopecia areata is commonly established based on clinical appearance, In cases of ambiguity, trichoscopy may be useful to avoid invasive procedures such as biopsy.
Treatment of alopecia areata is dependent on age of patient as well as the extent and duration of scalp involvement. Treatments include steroids, topical immunotherapy, topical minoxidil, anthralin, and immunosuppressants. Each case must be dealt with on a customized individual basis.
Platelets rich plasma (PRP) is an autologous preparation of platelets in concentrated plasma. Injection of PRP improves cutaneous ischemic conditions, increases vascular structures around hair follicles and induces the proliferation of dermal papilla cells by up regulating fibroblast growth factor 7 (FGF-7) .Anagen-associated angiogenesis has been suggested as one of the important factors in active hair growth, due to the secretion of vascular endothelial growth factor by the keratinocytes of the outer root sheath and fibroblasts of the dermal papilla .
Topical calcipotriol is a vitamin D analogue that regulates keratinocytes proliferation and differentiation. It can induce hair regrowth in Alopecia Areata lesions by regulation of the differentiation of B cells, T cells, dendritic cells, and Toll-like receptor expression. There are few reports evaluating the effect of calcipotriol in Alopecia Areata .
Patients with Alopecia Areata are characterized by an abnormal serum level of adipokines, particularly adiponectin and resistin. Adiponectin may be considered as a marker of severity of hair loss in alopecia areata. Impaired secretion of specific adipokines may play an important and complex role in the pathogenesis of Alopecia Areata and its continuity
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: CalcipotriolAbout 20 patients suffering from Alopecia areata , they will receive topical vit D3 analogue (calcipotriol) 0.005% twice daily for 3 months with follow up |
| Group B | Active comparator | Drug: CalcipotriolAbout 20 patients suffering from Alopecia areata , they will be injected by PRP intra lesional for 3 consecutive sessions 4weeks apart. |
| Group C | Active comparator | Drug: CalcipotriolAbout 20 patients suffering from Alopecia areata they will receive combined therapy ( PRP and topical vit D3 analogue). |
| Group D | Active comparator | Drug: CalcipotriolAbout 20 of Healthy control group . |
Who may qualify
- Ages
- 5 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients with non-severe alopecia areata , a severity of alopecia tool (SALT) score up to 2 with less than 50% of scalp involvement.
- No restriction of age , race, nor occupation
Key exclusion criteria (3 listed)
- Pregnant and lactating women, immunocompromised patients.
- Patients having active scalp inflammation.
- Patients who received systemic treatment for Alopecia Areata in the last 3 months or applied any topical or intradermal treatments in the last 4 weeks .
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 |
|---|---|---|
| CalcipotriolAlso: Platelet Rich PlasmaTo evaluate the efficacy of Calcipotriol on Alopecia Areata. | Drug | Group A, Group B, Group C, Group D |
Primary outcome
Efficacy of topical calcipotriol and platelet Rich Plasma in Alopecia Areata treatment
Time frame: from baseline to 3 months
Evaluating the patients suffering from Alopecia Areata clinically, with Severity of Alopecia Tool (SALT) score. As score of 0 means no hair loss, while a SALT score of 100 is complete hair loss. and this evaluation will be done by trichoscopy
2 secondary outcomes
serum adiponectin level.
Time frame: from baseline to 3 months
serum Adiponectin level in Alopecia Areata
Time frame: from baseline to 3 months
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 19 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Alopecia Areata
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Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (Apeced), Alopecia Areata
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Real-World Effectiveness of Ritlecitinib in Alopecia Areata Patients in the US: A Retrospective Analysis Using EHR and Claims Data
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Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib
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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.
Moustafa Adam, Professor study chair
Department of dermatology , Venerolgy and Andrology Faculty of Medicine Aswan university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcipotriol 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 2 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: finished, as of the sponsor's last update on 19 Oct 2023. 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?
Efficacy of topical calcipotriol and platelet Rich Plasma in Alopecia Areata treatment (time frame: from baseline to 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 19 Oct 2023.