Condition or disease | Intervention/treatment | Phase |
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Periorbital Hypermelanosis | Other: PRP | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | •The procedure:
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Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Evaluation of the Therapeutic Effect of Platelet Rich Plasma (PRP) in Periorbital Hyperpigmentation(POH) |
Estimated Study Start Date : | November 1, 2019 |
Estimated Primary Completion Date : | November 1, 2020 |
Estimated Study Completion Date : | December 1, 2020 |
Tracking Information | |||||
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First Submitted Date ICMJE | March 2, 2019 | ||||
First Posted Date ICMJE | March 5, 2019 | ||||
Last Update Posted Date | March 6, 2019 | ||||
Estimated Study Start Date ICMJE | November 1, 2019 | ||||
Estimated Primary Completion Date | November 1, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
cure rate [ Time Frame: 6 months ] assess cure rate of PRP in treatment of POH
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Evaluation of the Therapeutic Effect of Platelet Rich Plasma (PRP) in Periorbital Hyperpigmentation(POH) | ||||
Official Title ICMJE | Evaluation of the Therapeutic Effect of Platelet Rich Plasma (PRP) in Periorbital Hyperpigmentation(POH) | ||||
Brief Summary | To evaluate the saftey and efficicacy of autologous PRP in treatment of POH. | ||||
Detailed Description |
Periorbital hyperpigmentation (POH) is a common dermatological condition, also known as periorbital melanosis, periocular hyperpigmentation dark circles under the eyes (DC), infraorbital discoloration, infraorbital darkening, or idiopathic cutaneous hyperchromia of the orbital region. It is a common cosmetic condition that occurs in both sexes and may be considered to be normal variants of pigmentation . Periorbital hyperpigmentation is a multi-factorial entity.The proposed possible causative factors include genetic or heredity, excessive pigmentation, periorbital edema, thin and translucent lower eyelid skin, venous congestion with hemosiderin deposition, orbital structural problem and shadowing due to skin laxity & tear trough. Other factors such as underlying systemic, metabolic, hormonal diseases, nutritional deficiencies, drugs, allergic reactions, atopic dermatitis, sleep disorders, stress, alcohol consumption, smoking, frequent cosmetic use, frequent eye rubbing and lack of correction for errors of refraction like myopia are also implicated to POH . Periorbital hyperpigmentation is classified according to Ranu et al into five categories based on the causative factors 1. Constitutional type: seen as typical brownish curved band on lower eyelid or both. 2.Postinflammatory type: irregular patches of brown or grey pigmentation associated with features of lichenification.3. Vascular type: erythema or prominent capillaries or telangiectasia. 4. Shadow effect type: tear trough and eye bags due to sagging skin around eyes. 5. Others: anaemia, hormonal disturbances, nutritional deficiencies and chronic illnesses . Periorbital hyperpigmentation is graded into four groups according to the severity of the case to be treated;
The diagnosis of POH is mainly clinically, however, a thorough history and clinical assessment is necessary to identify the contributing etiologic factors. The cutaneous examination should be evaluated to detect the involvement of eyelids, extend beyond the periorbital region, color of hyperpigmentation, presence of any dermatological disease or scar, presence of any visible bulging, skin laxity, tear trough, superficial visible vasculature, in infraorbital region presence of pigmentation in other areas . Eye lid stretch test or manual stretching of the lower eyelid skin can help to differentiate between true pigmentation and shadowing effect . Wood's lamp examination is done to differentiate between the epidermal and dermal pigmentation.The variations in epidermal pigmentation become more apparent under Wood's light. For dermal pigmentation, this contrast is less pronounced . Dermatoscopy: It is a non-invasive diagnostic technique for the in vivo observation of pigmented skin lesion allowing a better visualization of surface and subsurface structures and being easy and feasible to use. It can be used to differentiate the type of POH whenever there is doubt while examining with naked eyes. The dermatoscopic findings of POH are- a) Vascular type: diffuse erythema pattern or multiple thin blood vessels or diffuse vascular network, b) Pigmented type: a pattern of multiple dots with different sizes and colors or a diff use network of pigments and c) Mixed type: Combination of vascular and pigmented type . Treatment of POH: There are a number of treatment options available for POH. Among the available treatment options for POH include:
The mechanism of action of PRP is based on the fact that platelets contain many growth factors in their alpha granules. These factors have a well-known role in the process of tissue repair. Thus, the concentration of these substances in injured tissues could be beneficial to providing more agility to the regeneration processes . PRP treatment is mainly effective for wrinkles, laxity, and secondary PIH-related dark circles. PRP can stimulate dermal fibroblast proliferation and collagen synthesis (Kim DH et al, 2011). Transforming growth factor-β1 and epidermal growth factor in PRP are suggested to inhibit melanin production via delayed extracellular signal-regulated kinase activation and inhibition of prostagandin-E2 expression/ tyrosinase enzyme activity, respectively (Yun WJ et al, 2013). In addition, PRP improves fat graft survival and can be used in combination with autologous fat grafts for dark circles |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Intervention Model Description: •The procedure:
Primary Purpose: Treatment |
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Condition ICMJE | Periorbital Hypermelanosis | ||||
Intervention ICMJE | Other: PRP
platelet rich plasma will be delivered by intradermal method using mestherapy needle.
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Study Arms ICMJE | Not Provided | ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
30 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 1, 2020 | ||||
Estimated Primary Completion Date | November 1, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 20 Years to 50 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Not Provided | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03862118 | ||||
Other Study ID Numbers ICMJE | PRP in POH | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | ARYousef, Assiut University | ||||
Study Sponsor ICMJE | Assiut University | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Assiut University | ||||
Verification Date | March 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |