Clinical trial

Comparison of the Effectiveness of Brightening Creams vs Laser Therapy (QS Nd:YAG 1064nm Laser) in Skin Hyperpigmentation After Sclerotherapy by Objective Measurement: A Randomized Controlled Monocentric Trial

Name

2021-D0062

Description

The treatment of leg veins and varicosis with sclerotherapy is one of the most frequently performed medical intervention in the western world. The most common local side effects of this treatment are hyperpigmentations caused by hemosiderin deposition in the skin as well as post inflammatory hyperpigmentation. Although skin hyperpigmentation after sclerotherapy is a common over several months up to years lasting side-effect with a strong aesthetic impact, scanty data exist about treatment options. Quality-Switched (QS) lasers are efficient in the removal of exogenous and endogenous pigments, such as tattoos as well as epidermal and dermal melanin deposits. The laser light is absorbed by pigment particles, leading to a fragmentation of these particles by a photothermal and photoacoustic effect. Smaller particles can be then phagocyted by macrophages, and transported via the lymphatic system into the lymph nodes. Furthermore, the positive effect of QS lasers in the management of cutaneous siderosis in stasis dermatitis and after sclerotherapy has been described in several cases. Triple cream including hydroquinone, tretinoin and a topical corticosteroid (eg dexamethasone), is the first line therapy in the treatment of post inflammatory hyperpigmentation. This randomized controlled study aims to evaluate the efficiency of two well-known depigmentation methods (QS laser and triple cream) for treatment of post sclerotherapy hyperpigmentation, compared with a control group performing no treatment.

Trial arms

Trial start

2022-03-03

Estimated PCD

2024-12-31

Trial end

2024-12-31

Status

Recruiting

Treatment

QS Nd:YAG laser

Patients will be treated with Quality-switched (QS) Neodymium-doped yttrium aluminum garnet (Nd:YAG) laser (MedLite® C6) operating at a wavelength of 1064 nm, fluence range from 2.1 J/cm2 to 8.1 J/cm2 with a 4-6mm spot size.

Arms:

Laser

Triple cream

Patients will be treated with a triple brightening cream (Pigmanorm®), applied daily, three times per week for 12 weeks on the lesion. Interruption for 4 days will be adopted in case of irritation/redness. 50+ sun protection cream will be used as well during the treatment period.

Arms:

Cream

Size

Primary endpoint

Equivalence of laser and cream in reducing post-sclerotherapy hyperpigmentation as assessed by SHI

16 weeks

Eligibility criteria

Inclusion Criteria: * Fitzpatrick skin type I-IV * Presence of at least 1 postinflammatory hyperpigmentation after sclerotherapy Exclusion Criteria: * History of adverse events related to short-pulsed laser therapy * Pregnant or breast-feeding women * Intention to become pregnant during the course of the study * History of intolerance or allergic reaction to triple cream or one of its ingredients * Prior treatment with parenteral gold therapy * Inability to understand the study content

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 66, 'type': 'ESTIMATED'}}

Updated at

2024-04-23

1 organization

1 product

2 indications

Organization

Product

Indication

Indication