Alopecia AreataEarly Phase 1NCT05251831
Comparative Study Efficacy and Safety of of Activated Versus Non-Activated PRP
A Early Phase 1 study testing Intradermal injection in people with Alopecia Areata, run by Al-Azhar University at 1 site in Egypt.
Trial summary
This was comparative prospective study conducted on 40 subjects, diagnosed with alopecia areata of 40 the scalp, carried in a period from February 2020 and March 2021 Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- Intradermal injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2020to 30 Mar 2021
- Phase
- Early Phase 1
- 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 19 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients diagnosed clinically and dermatoscopically as Alopecia areata of the scalp (uni- or 50 multilocularis).
- Age ranged between 18-50 years in both sex.
Who cannot join
- Previously treated patients.
- Pregnant women. 3 Patients with hematological disorders.
- 4. Local infection at the site. 5. Patients with Hemoglobin <10 g/dL and Platelet count <105/µL. 6. Patients suffer from chronic and psychiatric diseases. 7.Age below 18years or age above 50 years ago.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Activated Platelet Rich Plasma Versus Non-Activated Platelet Rich Plasma in Alopecia Areata
This was comparative prospective study conducted on 40 subjects, diagnosed with alopecia areata of 40 the scalp, carried in a period from February 2020 and March 2021
Read the detailed description
Alopecia areata is a common recurrent T cell-mediated autoimmune-induced non-scarring hair loss with not fully understood pathogenesis which affects nearly 2% of the general population during lifetime. The course of the disease is unpredictable and currently, no treatment is available for complete cure or prevention. Platelet-rich plasma is an autologous blood-derived product which widely spread in the last decades for the treatment of different dermatological conditions including different hair disorders.
The aim of this work was to evaluate the efficacy and safety of activated platelet-rich plasma in comparison to non-activated platelet-rich plasma in the treatment of alopecia areata.
- Conditions
- Alopecia Areata
- Being tested
- Intradermal injection
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intradermal injectionDrug
Also called Plasma rich in platelets
Platelet-rich plasma (PRP) therapy uses injections of a concentration of a patient's own platelets.
| Study group | Role | What they receive |
|---|---|---|
| Activated plasma rich in platelets | Experimental | Group A: patients were treated by intradermal injections of PRP activated with Calcium chloride 10% solution. Receives: Drug: Intradermal injection |
| Non- activated plasma rich in platelets | Placebo comparator | Group B: patients were treated by intradermal injections of PRP without activation. Receives: Drug: Intradermal injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hair length in group A
PRP as treatment option was in indicating its anti-inflammatory properties. 183 PRP effective in AA through anti-inflammatory mechanisms owing to its ability to suppress Monocyte 184 chemotactic protein-1 and owing to the presence of Transforming growth factor (β1 and β2) as was 185 shown by Amable and El-Sharkavy with coauthors
Measured: three months
Secondary outcomes (1)
Hair length in Group B
confirm that PRP is safe effective and well tolerated by 207 patients treatment modality for Alopecia areata. Beside this such method is cost effective as no need 208 any expensive tools for preparation and can be done in outpatients clinics easily.
Measured: five months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start1 Feb 2020
- Primary completion1 Feb 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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 Al-Azhar 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The 40 patients with alopecia areata will be divided into 2 groups: Group A: 20 patients will be treated by activated PRP with Calcium chloride (CaCl2). Those patients will be treated with an intradermal injection. Group B: 20 patients will be treated by non-activated PRP through intradermal injection
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hassan Nouh MD, Al-Azhar University
- Investigators
- Ahmed Mohamed abdelaal, Prof, Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05251831
- Sponsor's protocol ID
- Ahmed HN AA
- Status last verified
- Feb 2022
- First submitted
- 2 Jan 2022
- Last updated
- 23 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aithal GP, Watkins PB, Andrade RJ, Larrey D, Molokhia M, Takikawa H, Hunt CM, Wilke RA, Avigan M, Kaplowitz N, Bjornsson E, Daly AK. Case definition and phenotype standardization in drug-induced liver injury. Clin Pharmacol Ther. 2011 Jun;89(6):806-15. doi: 10.1038/clpt.2011.58. Epub 2011 May 4.
PubMed 21544079Alves R, Grimalt R. A Review of Platelet-Rich Plasma: History, Biology, Mechanism of Action, and Classification. Skin Appendage Disord. 2018 Jan;4(1):18-24. doi: 10.1159/000477353. Epub 2017 Jul 6.
PubMed 29457008Kuty-Pachecka M. Psychological and psychopathological factors in alopecia areata. Psychiatr Pol. 2015;49(5):955-64. doi: 10.12740/PP/39064. English, Polish.
PubMed 26688846Li F, Ohnishi R, Yamada Y, Kubota J, Domen K, Yamada A, Zhou H. Carbon supported TiN nanoparticles: an efficient bifunctional catalyst for non-aqueous Li-O2 batteries. Chem Commun (Camb). 2013 Feb 11;49(12):1175-7. doi: 10.1039/c2cc37042e.
PubMed 23289098Strazzulla LC, Wang EHC, Avila L, Lo Sicco K, Brinster N, Christiano AM, Shapiro J. Alopecia areata: Disease characteristics, clinical evaluation, and new perspectives on pathogenesis. J Am Acad Dermatol. 2018 Jan;78(1):1-12. doi: 10.1016/j.jaad.2017.04.1141.
PubMed 29241771
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Activated Platelet Rich Plasma Versus Non-Activated Platelet Rich Plasma in Alopecia Areata
- ClinicalTrials.gov ID
- NCT05251831
- Acronym / sponsor ID
- Ahmed HN AA
- Conditions
- Alopecia Areata
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 23 Feb 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.
This was comparative prospective study conducted on 40 subjects, diagnosed with alopecia areata of 40 the scalp, carried in a period from February 2020 and March 2021
Detailed description
Alopecia areata is a common recurrent T cell-mediated autoimmune-induced non-scarring hair loss with not fully understood pathogenesis which affects nearly 2% of the general population during lifetime. The course of the disease is unpredictable and currently, no treatment is available for complete cure or prevention. Platelet-rich plasma is an autologous blood-derived product which widely spread in the last decades for the treatment of different dermatological conditions including different hair disorders.
The aim of this work was to evaluate the efficacy and safety of activated platelet-rich plasma in comparison to non-activated platelet-rich plasma in the treatment of alopecia areata.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- The 40 patients with alopecia areata will be divided into 2 groups: Group A: 20 patients will be treated by activated PRP with Calcium chloride (CaCl2). Those patients will be treated with an intradermal injection. Group B: 20 patients will be treated by non-activated PRP through intradermal injection
| Arm | Type | Receives |
|---|---|---|
| Activated plasma rich in platelets | Experimental | Drug: Intradermal injectionGroup A: patients were treated by intradermal injections of PRP activated with Calcium chloride 10% solution. |
| Non- activated plasma rich in platelets | Placebo comparator | Drug: Intradermal injectionGroup B: patients were treated by intradermal injections of PRP without activation. |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients diagnosed clinically and dermatoscopically as Alopecia areata of the scalp (uni- or 50 multilocularis).
- Age ranged between 18-50 years in both sex.
Key exclusion criteria (3 listed)
- Previously treated patients.
- Pregnant women. 3 Patients with hematological disorders.
- 4. Local infection at the site. 5. Patients with Hemoglobin <10 g/dL and Platelet count <105/µL. 6. Patients suffer from chronic and psychiatric diseases. 7.Age below 18years or age above 50 years ago.
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 |
|---|---|---|
| Intradermal injectionAlso: Plasma rich in plateletsPlatelet-rich plasma (PRP) therapy uses injections of a concentration of a patient's own platelets. | Drug | Activated plasma rich in platelets, Non- activated plasma rich in platelets |
Primary outcome
Hair length in group A
Time frame: three months
PRP as treatment option was in indicating its anti-inflammatory properties. 183 PRP effective in AA through anti-inflammatory mechanisms owing to its ability to suppress Monocyte 184 chemotactic protein-1 and owing to the presence of Transforming growth factor (β1 and β2) as was 185 shown by Amable and El-Sharkavy with coauthors
1 secondary outcome
Hair length in Group B
Time frame: five 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 23 Feb 2022.
- Background: PubMed 21544079Aithal GP, Watkins PB, Andrade RJ, Larrey D, Molokhia M, Takikawa H, Hunt CM, Wilke RA, Avigan M, Kaplowitz N, Bjornsson E, Daly AK. Case definition and phenotype standardization in drug-induced liver injury. Clin Pharmacol Ther. 2011 Jun;89(6):806-15. doi: 10.1038/clpt.2011.58. Epub 2011 May 4.
- Background: PubMed 29457008Alves R, Grimalt R. A Review of Platelet-Rich Plasma: History, Biology, Mechanism of Action, and Classification. Skin Appendage Disord. 2018 Jan;4(1):18-24. doi: 10.1159/000477353. Epub 2017 Jul 6.
- Background: PubMed 26688846Kuty-Pachecka M. Psychological and psychopathological factors in alopecia areata. Psychiatr Pol. 2015;49(5):955-64. doi: 10.12740/PP/39064. English, Polish.
- Background: PubMed 23289098Li F, Ohnishi R, Yamada Y, Kubota J, Domen K, Yamada A, Zhou H. Carbon supported TiN nanoparticles: an efficient bifunctional catalyst for non-aqueous Li-O2 batteries. Chem Commun (Camb). 2013 Feb 11;49(12):1175-7. doi: 10.1039/c2cc37042e.
- Background: PubMed 29241771Strazzulla LC, Wang EHC, Avila L, Lo Sicco K, Brinster N, Christiano AM, Shapiro J. Alopecia areata: Disease characteristics, clinical evaluation, and new perspectives on pathogenesis. J Am Acad Dermatol. 2018 Jan;78(1):1-12. doi: 10.1016/j.jaad.2017.04.1141.
- 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.
Ahmed Mohamed abdelaal, Prof principal investigator
Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Intradermal injection in people with Alopecia Areata, run by Al-Azhar 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 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 23 Feb 2022. 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Hair length in group A (time frame: three months). 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 NCT05251831, which also lists 5 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 23 Feb 2022.