Acne VulgarisNCT06281782
Platelet-rich Plasma With Topical Retinoids Versus Topical Retinoids Alone in Acne Vulgaris
A study testing topical retinoids and platalet rich plasma in people with Acne Vulgaris, run by Assiut University at 1 site in Egypt.
Trial summary
Acne vulgaris is the most common skin disease in adolescents and young adults. Adult or post-adolescent acne occurs in 12-14% of this population.It is a chronic, inflammatory disease of the pilosebaceous unit .The clinical features of acne include seborrhoea, non-inflammatory lesions (open and closed comedones)… Read more about this study
- Who is it for?
- Ages 12 to 35 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- topical retinoids and platalet rich plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to May 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 12 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with facial acne vulgaris
- Age from 12 to 35 years old
Who cannot join
- Pregnant or lactating women.
- patients with history of coagulation disorders.
- chronic diseases (chronic renal failure, hepatic insufficiency, cardiovascular disorders, uncontrolled diabetes mellitus, thyroid disorders, anemia, autoimmune diseases).
- patients with unrealistic expectations.
- Patients received any systemic treatment in the last 6 months.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine
Asyut
Howida Abdalla, d.howida@windowslive.com
About this study
Official title: Platelet-rich Plasma With Topical Retinoids Versus Topical Retinoids Alone in Acne Vulgaris: Randomized Clinical Trial
Acne vulgaris is the most common skin disease in adolescents and young adults. Adult or post-adolescent acne occurs in 12-14% of this population.It is a chronic, inflammatory disease of the pilosebaceous unit .The clinical features of acne include seborrhoea, non-inflammatory lesions (open and closed comedones), inflammatory lesions (papules and pustules), and various degrees of scarring.
Platelet-rich plasma (PRP) is prepared by simple centrifugation of whole blood to concentrate platelets and simultaneously remove red blood cells. The resultant supernatant is the PRP that contains various growth factors, including platelet-derived growth factor (PDGF), transforming growth factor (TGF), fibroblast growth factor (FGF), vascular endothelial growth factor (VEGF), and hepatocyte growth factor (HGF).These growth factors are involved in the healing of soft tissue and can regulate cellular processes such as chemotaxis, angiogenesis, mitogenesis, differentiation, and metabolism .
Read more
Topical retinoids are used in the treatment of both noninflammatory and inflammatory acne.Food and Drug Administration (FDA) approved three topical retinoids: adapalene, tazarotene, and tretinoin. These agents help normalize follicular keratinization and decrease keratinocyte cohesiveness, thereby reducing follicular occlusion and comedon formation .Topical retinoids also compete with factors involved in the acne inflammation response, enhance penetration of other topical acne medications, and accelerate the resolution of acne-induced post-inflammatory hyperpigmentation.
Updates from the Global Alliance on Improving Outcomes in Acne consider topical retinoids as first-line therapy, individually or in combination with benzoyl peroxide. However, the common side effects of skin irritation and discomfort may impede adherence to long-term therapy.
For patients with acne, combination therapy with a topical retinoid and platelet-rich plasma (PRP) has not yet been tested.
PRP with topical retinoids will be evaluated and campared with topical retinoids alone in acne tretment.
- Conditions
- Acne Vulgaris
- Being tested
- topical retinoids and platalet rich plasma
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topical retinoids and platalet rich plasmaOther
We will analyse both monotherapy with a topical retinoid alone and combination therapy with a topical retinoid and platelet-rich plasma (PRP) to elucidate their role in acne treatment and provide possible recommendations for their use.
| Study group | Role | What they receive |
|---|---|---|
| topical retinoid and platelet-rich plasma (PRP) group | Active comparator | Not described Receives: Other: topical retinoids and platalet rich plasma |
| topical retinoid group | Active comparator | Not described Receives: Other: topical retinoids and platalet rich plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of acne lasions
record percentage of improvement for each patient after completion of the treatment by comparing before and after digital photographs according to quartile grading scale
Measured: after 1 month of treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Jan 2024
- Primary completionApr 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies 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
- Model description
- Topical retinoids versus topical retinoids wit PRP in acne vulgaris treatment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Howida Omar Twisy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06281782
- Sponsor's protocol ID
- PRP with topical retinoids
- Status last verified
- Feb 2024
- First submitted
- 29 Jan 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- 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 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet-rich Plasma With Topical Retinoids Versus Topical Retinoids Alone in Acne Vulgaris: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06281782
- Acronym / sponsor ID
- PRP with topical retinoids
- Conditions
- Acne Vulgaris
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 28 Feb 2024 (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.
Acne vulgaris is the most common skin disease in adolescents and young adults. Adult or post-adolescent acne occurs in 12-14% of this population.It is a chronic, inflammatory disease of the pilosebaceous unit .The clinical features of acne include seborrhoea, non-inflammatory lesions (open and closed comedones), inflammatory lesions (papules and pustules), and various degrees of scarring.
Platelet-rich plasma (PRP) is prepared by simple centrifugation of whole blood to concentrate platelets and simultaneously remove red blood cells. The resultant supernatant is the PRP that contains various growth factors, including platelet-derived growth factor (PDGF), transforming growth factor (TGF), fibroblast growth factor (FGF), vascular endothelial growth factor (VEGF), and hepatocyte growth factor (HGF).These growth factors are involved in the healing of soft tissue and can regulate cellular processes such as chemotaxis, angiogenesis, mitogenesis, differentiation, and metabolism .
Topical retinoids are used in the treatment of both noninflammatory and inflammatory acne.Food and Drug Administration (FDA) approved three topical retinoids: adapalene, tazarotene, and tretinoin. These agents help normalize follicular keratinization and decrease keratinocyte cohesiveness, thereby reducing follicular occlusion and comedon formation .Topical retinoids also compete with factors involved in the acne inflammation response, enhance penetration of other topical acne medications, and accelerate the resolution of acne-induced post-inflammatory hyperpigmentation.
Updates from the Global Alliance on Improving Outcomes in Acne consider topical retinoids as first-line therapy, individually or in combination with benzoyl peroxide. However, the common side effects of skin irritation and discomfort may impede adherence to long-term therapy.
For patients with acne, combination therapy with a topical retinoid and platelet-rich plasma (PRP) has not yet been tested.
PRP with topical retinoids will be evaluated and campared with topical retinoids alone in acne tretment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Topical retinoids versus topical retinoids wit PRP in acne vulgaris treatment
| Arm | Type | Receives |
|---|---|---|
| topical retinoid and platelet-rich plasma (PRP) group | Active comparator | Other: topical retinoids and platalet rich plasma |
| topical retinoid group | Active comparator | Other: topical retinoids and platalet rich plasma |
Who may qualify
- Ages
- 12 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients with facial acne vulgaris
- Age from 12 to 35 years old
Key exclusion criteria (5 listed)
- Pregnant or lactating women.
- patients with history of coagulation disorders.
- chronic diseases (chronic renal failure, hepatic insufficiency, cardiovascular disorders, uncontrolled diabetes mellitus, thyroid disorders, anemia, autoimmune diseases).
- patients with unrealistic expectations.
- Patients received any systemic treatment in the last 6 months.
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 |
|---|---|---|
| topical retinoids and platalet rich plasmaWe will analyse both monotherapy with a topical retinoid alone and combination therapy with a topical retinoid and platelet-rich plasma (PRP) to elucidate their role in acne treatment and provide possible recommendations for their use. | Other | topical retinoid and platelet-rich plasma (PRP) group, topical retinoid group |
Primary outcome
change of acne lasions
Time frame: after 1 month of treatment completion
record percentage of improvement for each patient after completion of the treatment by comparing before and after digital photographs according to quartile grading scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing topical retinoids and platalet rich plasma in people with Acne Vulgaris, 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 2 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: status not confirmed, as of the sponsor's last update on 28 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Howida Omar Twisy (+201029512930 ext. egypt, d.howida@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of acne lasions (time frame: after 1 month of treatment completion). 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 28 Feb 2024.