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Brightening Cream and Lasers in Post-sclerotherapy Hyperpigmentation

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ClinicalTrials.gov Identifier: NCT05165524
Recruitment Status : Recruiting
First Posted : December 21, 2021
Last Update Posted : June 10, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

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.


Condition or disease Intervention/treatment Phase
Hyperpigmentation Varicosis Device: QS Nd:YAG laser Drug: Triple cream Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : March 3, 2022
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Arm Intervention/treatment
Active Comparator: Laser Device: 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.

Active Comparator: Cream Drug: 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.

No Intervention: Control



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05165524


Contacts
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Contact: Kristine Heidemeyer, MD 316322218 ext +41 Kristine.Heidemeyer@insel.ch

Locations
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Switzerland
Department of dermatology, University Hospital Inselspital, Bern Recruiting
Bern, Switzerland, 3010
Contact: Kristine Heidemeyer, MD    316322218 ext +41    Kristine.Heidemeyer@insel.ch   
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Kristine Heidemeyer, MD University Hospital Inselspital, Bern
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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT05165524    
Other Study ID Numbers: 2021-D0062
First Posted: December 21, 2021    Key Record Dates
Last Update Posted: June 10, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Inselspital, Berne:
laser
Nd:YAG
Additional relevant MeSH terms:
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Hyperpigmentation
Pigmentation Disorders
Skin Diseases