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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT03114514 |
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Date of registration:
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11/04/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy of Platelet-rich Plasma (PRP) in the Treatment of Dark Circles Under the Eyes
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Scientific title:
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Efficacy of Platelet-Rich Plasma (PRP) in the Treatment of Periorbital Hyperpigmentation |
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Date of first enrolment:
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June 17, 2016 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03114514 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Syrian Arab Republic
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Contacts
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Name:
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Raed Sameer Noueihed, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Resident at the Dermatology and venereology Hospital of Damascus university. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with periorbital hyperpigmentation
Exclusion Criteria:
- patients with known platelet dysfunction syndrome
- patients with platelet count less than 100,000 ul
- patient with hemodynamic instability
- patients with severe systemic illness or malignancy or chronic medical illness (e.g.
diabetes, chronic infections, and blood dyscrasias).
- patients with local skin disorders or active herpes infection at the site of the
procedure.
- patients on anti-coagulants therapy or non-steroidal anti-inflammatory drugs (NSAID)
within 48 hours of procedure,
- patients with corticosteroid injection at treatment site within 1 month, systemic use
of corticosteroids within 2 weeks
- patients with recent fever or illness, and hemoglobin level< 10 g/dl.
- pregnancy
- history of keloidal scarring.
Age minimum:
15 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Periorbital Hyperpigmentation
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Intervention(s)
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Biological: PRP
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Primary Outcome(s)
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Change in Skin Color
[Time Frame: Color shade will be measured at one month following the first injection (T1) and at three months following the third injection (T2)]
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Secondary Outcome(s)
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Satisfaction
[Time Frame: Satisfaction will be measured at three months following the last injection.]
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Secondary ID(s)
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UDMS-Dermat-01-2017
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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