Efficiency of Fractional-Laser Resurfacing Followed by To... | NCT03535051

Studies
Efficiency of Fractional-Laser Resurfacing Followed by Topical Tacrolimus 0.03% Cream vs Tacrolimus Alone in Vitiligo

NCT03535051

Sponsor

Kasr El Aini Hospital

Status

Completed

Last Update Posted

Sep 13, 2018Actual

Enrollment

27Actual

Phase

Not Applicable

Conditions

Stable Vitiligo

Interventions

fractional carbon dioxide laser
Tacrolimus Oint 0.03%

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2015Actual

Primary Completion Date

Jan 1, 2017Actual

Completion Date

Feb 1, 2017Actual

First Submitted Date

May 12, 2018

First Submission Date that Met QC Criteria

May 12, 2018

First Posted Date

May 24, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 11, 2018

Last Update Posted Date

Sep 13, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim the clinical trial was to find out whether fractional CO₂ laser sessions in combination with application of daily topical tacrolimus 0.03% would enhance the action of the drug and pose as a possible combination treatment option for stable vitiligo lesions. This combination treatment was applied to one side of the body and the response was compared to the response of the lesions on the other side of the body to daily topical tacrolimus 0.03% alone, which was used as control.

Detailed Description

Each patient included in the study received treatment A on the lesions on one side of his/her body, and treatment B on the other side.

Treatment A included 4 monthly sessions of fractional CO₂ laser on the lesions plus application of topical tacrolimus 0.03% (Tarolimus) on the lesions 6 hours after each session and twice daily in between the sessions and for 1 month after the last session.

Treatment B included only the application of topical tacrolimus 0.03% (Tarolimus) on the lesions twice daily for 5 months.

Fractional laser The device used was DEKA, SmartXide DOT (Dermal Optical Thermolysis), Italy fractional Carbon Dioxide Laser (fig. 8). This device is an ablative fractional 10,6000 nm CO² Laser with variable pulse duration (0.2-2 ms), 350-μm beam spot size, scanner area of 15x15 mm and penetration depth between 200 to 1,500 μm.

Tacrolimus ointment 0.03% (Tarolimus) Applied on the lesions treated by fractional CO² laser 6 hours after each laser session, then twice daily in between the sessions and 1 month after the last session.

Applied on the lesions on the other half of the body (not treated with fractional CO² laser) twice daily for 4 months.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

27Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment A	Experimental	Combination treatment of fractional carbon dioxide laser monthly sessions and topical tacrolimus 0.03% daily application (Tacrolimus Oint 0.03%)	Device: fractional carbon dioxide laser Drug: Tacrolimus Oint 0.03%
Treatment B	Active Comparator	Monotherapy with only topical tacrolimus 0.03% daily intervention: Tacrolimus Oint 0.03%	Drug: Tacrolimus Oint 0.03%

Interventions

Name	Type	Description	Arm Group Labels	Other Names
fractional carbon dioxide laser	Device	Monthly fractional carbon dioxide laser sessions	Treatment A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
repigmentation	reduction in Vitiligo Area Scoring Index of lesions	5 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Patients with stable vitiligo for at least 6 months, stability being defined as no eruption of fresh lesions and no extension of pre-existing lesions.
Age ≧ 12 years.
Symmetrical vitiligo.
Three month treatment-free period.

Exclusion criteria:

Patients younger than 12 years of age.
Non-stable lesions.
Non-symmetrical vitiligo.
Patients currently on other lines of treatment.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ola M AbuZeid, MD	Kasr Al Aini dermatology department	Study Director
Dina ElSharkawy, MD	Kasr Al Aini dermatology department	Study Director

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014820	Vitiligo

Ancestor Terms

ID	Term
D017496	Hypopigmentation
D010859	Pigmentation Disorders
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

A total of 152 lesions in different areas of the body were evaluated in the study. Seventy six lesions received the combination treatment and 76 received topical tacrolimus alone. Forty six lesions were in the head and neck region, 40 were acral in location, 36 were in the upper and lower limbs, 22 lesions were over bony prominences and 8 lesions were present on the trunk.