Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT03862118 |
| Other study ID # |
PRP in POH |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2019 |
| Est. completion date |
December 1, 2020 |
Study information
| Verified date |
March 2019 |
| Source |
Assiut University |
| Contact |
azza rady, doctor |
| Phone |
01275494347 |
| Email |
azzaradyyousef2019[@]yahoo.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
To evaluate the saftey and efficicacy of autologous PRP in treatment of POH.
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;
- Grade1: characterized by faint pigmentation of infraorbital region.
- Grade 2: pigmentation is more pronounced.
- Grade3: deep dark color, all four lids involved.
- Grade 4: grade 3 + pigmentation spreading beyond infraorbital fold .
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:
1. Topical Applications: The various topical bleaching agents are hydroquinone, kojic acid,
a triple combination, azelaic acid, arbutin, topical vitamin C. Out of these topical
agents the most widely used is hydroquinone, used in a strength of 2% to 6% .
2. Chemical Peelings: Chemical peelings could be used alone or in combination therapy with
topical treatments. Glycolic acid 20% is the most commonly used peeling in the treatment
of POH. Lactic acid 15% + TCA 3.75% combination is very effective treatment option for
POH .
3. Lasers: lasers have been used increasingly in cosmetic dermatology. Periorbital
hyperpigmentation has been successfully treated with various noninvasive lasers that
target pigment and vascularity. Various lasers that have been used for treating dark
circles are: Q switched ruby laser (694 nm), Q switched alexanderite laser, and Nd:Yag
laser (1064nm).
4. Platelet-rich plasma (PRP): PRP is a generic term used to describe a plasma suspension
obtained from whole blood, prepared so as to contain platelet concentrations higher than
those normally found in circulating blood.
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
