The Use of Sunscreen Starting on the First Day After Abla... | NCT01756664

Studies
The Use of Sunscreen Starting on the First Day After Ablative Fractional Skin Resurfacing

NCT01756664

Sponsor

Mahidol University

Status

Unknown status

Last Update Posted

Dec 27, 2012Estimated

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Interventions

Sunscreen
Vaseline

Countries

Thailand

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
SI402/2012	Other Identifier	Faculty of Medicine Siriraj Hospital, Mahidol University

Status Module

Record Verification Date

Aug 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2012

Primary Completion Date

Dec 2012Actual

Completion Date

Aug 2013Estimated

First Submitted Date

Dec 20, 2012

First Submission Date that Met QC Criteria

Dec 26, 2012

First Posted Date

Dec 27, 2012Estimated

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

Dec 26, 2012

Last Update Posted Date

Dec 27, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

- The use of sunscreen on the first day after fractional ablative skin resurfacing may reduce the risk of post-inflammatory hyperpigmentation

Detailed Description

The use of sunscreen on the first day after fractional ablative skin resurfacing may reduce the risk of post-inflammatory hyperpigmentation (PIH)
Therefore, we conducted the study to evaluate the efficacy of the use of sunscreen on the first day after fractional ablative skin resurfacing in reducing the risk of PIH.

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

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	Placebo Comparator	Vaseline has been used on the first day after laser treatment	Other: Vaseline
Sunscreen	Active Comparator	Sunscreen has been used on the first day after laser treatment	Other: Sunscreen

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sunscreen	Other		Sunscreen
Vaseline

Measure	Description	Time Frame
Melanin Index		3 Month

Measure	Description	Time Frame
Erythema Index		3 Months

Measure	Description	Time Frame
Transepidermal Water Loss		1 Week

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who want to receive fractional ablative laser resurfacing for acne scars

Exclusion Criteria:

Pregnancy
Lactation
Age < 18

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rungsima Wanitphakdeedecha, MD	Contact			rungsima.wan@mahidol.ac.th

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University	Recruiting	Bangkok		10700	Thailand

Type	Date	Date Unknown
Release	May 23, 2013
Reset	Jul 11, 2013
Release	Apr 10, 2015
Reset	Apr 28, 2015

Submission Tracking

Estimated Results First Submitted Date

May 23, 2013

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
May 23, 2013			Jul 11, 2013
Apr 10, 2015

Intervention Browse Module

MeSH Terms

ID	Term
D013473	Sunscreening Agents
D010577	Petrolatum

Ancestor Terms

ID	Term
D011837	Radiation-Protective Agents
D020011	Protective Agents
D045505	Physiological Effects of Drugs
D020228	Pharmacologic Actions

Browse Leaves

Not provided

Browse Branches

Not provided