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NCT Number: NCT05165524

Brightening Cream and Lasers in Post-sclerotherapy Hyperpigmentation

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.

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Key information

Conditions

Hyperpigmentation Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases Varicosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of dermatology, University Hospital Inselspital, Bern

Bern, 3010, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

QS Nd:YAG laser

Device

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.

Triple cream

Drug

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.

Primary outcomes

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

    Time frame: 16 weeks

    Equivalence of laser and cream groups in reducing post-sclerotherapy hyperpigmentation as assessed by Skin Hyperpigmentation Index (SHI), ranging from 1 to 4, with higher score indicating a worst hyperpigmentation.

Secondary outcomes

  1. Efficacy of laser and cream in reducing post-sclerotherapy hyperpigmentation compared to control group as assessed by SHI

    Time frame: 4, 8, 12, 16 weeks

    Any reduction of post-sclerotherapy hyperpigmentation in laser and cream compared to control group as assessed by Skin Hyperpigmentation Index (SHI), ranging from 1 to 4, with higher score indicating a worst hyperpigmentation.

  2. Efficacy of laser and cream in reducing post-sclerotherapy hyperpigmentation compared to control group as assessed by PGA

    Time frame: 4, 8, 12, 16 weeks

    Any reduction of post-sclerotherapy hyperpigmentation in laser and cream compared to control group as assessed by 6-point Physician Global Assessment (PGA), based on before-after pictures of lesions assessment, ranging from 1 to 6, with higher scores indicating a better outcome.

  3. Patient's satisfaction related to laser and cream in reducing post-sclerotherapy hyperpigmentation compared to control group

    Time frame: 16 weeks

    Any difference of patient's satisfaction between laser and cream compared to control group as assessed by a 9-point anchored visual analogue scale (VAS), ranging from -4 to +4, with negative scores indicating a worsening of condition, with 0 indicating no difference and with positive scores indicating an improvement.

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Dec 21, 2021
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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