Brightening Cream and Lasers in Post-sclerotherapy Hyperpigmentation

NCT05165524 | Completed

• 1 other identifier: 2021-D0062
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hyperpigmentation; Varicosis

Keywords

laser; Nd:YAG

Outcome Measures

Primary Outcomes (1)

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

  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.

  16 weeks

Secondary Outcomes (3)

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

  4, 8, 12, 16 weeks

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

  4, 8, 12, 16 weeks

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

  16 weeks

Study Arms (3)

Laser

ACTIVE COMPARATOR

Device: QS Nd:YAG laser

Cream

ACTIVE COMPARATOR

Drug: Triple cream

Control

NO INTERVENTION

Interventions

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.

Laser

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.

Cream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fitzpatrick skin type I-IV
• Presence of at least 1 postinflammatory hyperpigmentation after sclerotherapy

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Department of dermatology, University Hospital Inselspital, Bern

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Hyperpigmentation

Condition Hierarchy (Ancestors)

Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Kristine Heidemeyer, MD

  Insel Gruppe AG, University Hospital Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: December 21, 2021
• Study Start: March 3, 2022
• Primary Completion: January 14, 2025
• Study Completion: January 14, 2025
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)