## Protocol Section
### Identification Module
**NCT ID:** NCT01085279

**Brief Title:** Fractional Laser as Treatment Option for Various Pigment Disorders (Fractional-3)

**Official Title:** Non-ablative 1,550 nm Fractional Laser Therapy Versus Triple Topical Therapy for the Treatment of Melasma: a Randomized Controlled Split-face Study

#### Organization Study ID Info
**ID:** fractional-3
#### Organization
**Class:** OTHER
**Full Name:** Netherlands Institute for Pigment Disorders
### Status Module
#### Completion Date
**Date:** 2010-02

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2010-03-11

**Type:** ESTIMATED

**Last Update Submit Date:** 2010-03-10

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2010-02

**Type:** ACTUAL

#### Start Date
**Date:** 2009-03

**Status Verified Date:** 2010-03

#### Study First Post Date
**Date:** 2010-03-11
**Type:** ESTIMATED
**Study First Submit Date:** 2010-03-10
**Study First Submit QC Date:** 2010-03-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Netherlands Institute for Pigment Disorders

#### Responsible Party

**Old Name Title:** Albert Wolkerstorfer, MD PhD

**Old Organization:** Netherlands Institute for Pigment Disorders

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The purpose of this study is to determine whether the use of non-ablative fractional laser is safe and effective in the treatment of melasma.

### Conditions Module

**Conditions:**

- Pigmentation Disorder

**Keywords:**

- fractional laser

- melasma

- topical bleaching

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 29

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** In each patient, one side of the face was treated with non-ablative fractional laser in four-five sessions.

Note: this study had a split-face design. In each patient, each side of the face was randomized to receive either non-ablative fractional laser therapy or triple topical therapy.

**Intervention Names:**

- Device: Fraxel Restore, Solta Medical Inc. (Non-ablative fractional laser)

**Label:** Non-ablative fractional laser

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** In each patient, one side of the face was treated with triple topical therapy (Hydroquinone 5%, tretinoin 0.05%, triamcinolone acetonide 0.1%) during 15 weeks.

Note: this study had a split-face design. In each patient, each side of the face was randomized to receive either non-ablative fractional laser therapy or triple topical therapy.

**Intervention Names:**

- Drug: Modified Kligman's formula (Triple topical therapy)

**Label:** Triple topical therapy

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Non-ablative fractional laser

**Description:** 1,550 nm non-ablative fractional laser Irradiance: 15 mJ/microbeam. Coverage: 14-20%. Number of treatment sessions: 4-5

**Name:** Fraxel Restore, Solta Medical Inc. (Non-ablative fractional laser)

**Other Names:**

- Fraxel re:store, Solta Medical Inc., Hayward, CA

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Triple topical therapy

**Description:** Hydroquinone 5%, tretinoin 0.05%, triamcinolone acetonide 0.1% once a day during 15 weeks

**Name:** Modified Kligman's formula (Triple topical therapy)

**Other Names:**

- modified Kligman formula

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Improvement of hyperpigmentation was assessed by an independent blinded dermatologist. The results were scored on a scale from zero to six (0: total clearance (100% improvement), 1: almost total clearance (90-99% improvement), 2: distinct clearance (75-89% improvement) 3: moderate clearance (50-74% improvement) 4: mild clearance (25-49% improvement) 5: no change, 6: worsening of hyperpigmentation).

**Measure:** Physician's global assessment

**Time Frame:** T0, 3 weeks, and 3 and 6 months follow-up

#### Secondary Outcomes

**Description:** Improvement of hyperpigmentation was assessed by color measurement through reflectance spectroscopy (Microflash 200 d, Datacolor International, Lawrenceville, GA). This instrument, with an aperture of 4 mm, determines color by measuring the intensity of reflected light of particular wavelengths. In this study, the obtained L value, indicating the lightness of the measured area of skin, was used.

**Measure:** L-value

**Time Frame:** T0, 3 weeks and 3 and 6 months follow-up

**Description:** Melanin index was measured using a spectrometer (Derma-Spectrometer, Cortex Technology ApS, Hadsund, Denmark) in order to assess changes in the amount of dermal and epidermal melanin.

**Measure:** Melanin index

**Time Frame:** T0, 3 weeks and 3, and 6 months follow-up

**Description:** Patients were asked to score the improvement of hyperpigmentation on a visual analogue scale (VAS) from 0 to 10 (Patient's Global Assessment, PGA) at all follow-up moments.

**Measure:** Patient's global assessment

**Time Frame:** 3 weeks, 3 and 6 months follow-up

**Description:** Patient's satisfaction was scored on a visual analogue scale (VAS) from 0 to 10.

**Measure:** Patient's satisfaction

**Time Frame:** 3 weeks, 3 and 6 months follow-up

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Melasma
* Subjects attending the outpatient department of the Netherlands Institute for Pigment Disorders
* Age at least 18 years
* Subject is willing and able to give written informed consent

Exclusion Criteria:

* use of bleaching creams during the past six weeks
* history of keloid
* active eczema
* suspected hypersensitivity to lidocaine or triple therapy
* use of isotretinoin in the past six months
* high exposure of the lesion to sunlight or UV light (UVA or UVB).

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Amsterdam

**Country:** Netherlands

**Facility:** Netherlands Institute for Pigment disorders

**Zip:** 1105 AZ

#### Overall Officials

**Official 1:**

**Affiliation:** Netherlands Institute for Pigment Disorders

**Name:** Albert Wolkerstorfer, MD PhD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012871

- Term: Skin Diseases

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

### Condition Browse Module - Browse Leaves

- ID: M21089

- Name: Facies

- Relevance: LOW

- As Found: Unknown

- ID: M13754

- Name: Pigmentation Disorders

- Relevance: HIGH

- As Found: Pigmentation Disorder

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010859

- Term: Pigmentation Disorders

### Intervention Browse Module - Browse Branches

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: Derm

- Name: Dermatologic Agents

### Intervention Browse Module - Browse Leaves

- ID: M16975

- Name: Triamcinolone Acetonide

- Relevance: LOW

- As Found: Unknown

- ID: M16974

- Name: Triamcinolone

- Relevance: LOW

- As Found: Unknown

- ID: M237966

- Name: Triamcinolone hexacetonide

- Relevance: LOW

- As Found: Unknown

- ID: M209573

- Name: Triamcinolone diacetate

- Relevance: LOW

- As Found: Unknown

- ID: M16965

- Name: Tretinoin

- Relevance: LOW

- As Found: Unknown

- ID: M261781

- Name: Hydroquinone

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
