NCT01756664

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 27, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

December 27, 2012

Status Verified

August 1, 2012

Enrollment Period

4 months

First QC Date

December 20, 2012

Last Update Submit

December 26, 2012

Conditions

PIH

Outcome Measures

Primary Outcomes (1)

  • Melanin Index

    3 Month

Secondary Outcomes (1)

  • Erythema Index

    3 Months

Other Outcomes (1)

  • Transepidermal Water Loss

    1 Week

Study Arms (2)

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

SunscreenOTHER
Sunscreen
VaselineOTHER
Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pregnancy
  • Lactation
  • Age \< 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

RECRUITING

MeSH Terms

Interventions

Sunscreening AgentsPetrolatum

Intervention Hierarchy (Ancestors)

Radiation-Protective AgentsProtective AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesDermatologic AgentsTherapeutic UsesCosmeticsSpecialty Uses of ChemicalsHydrocarbonsOrganic Chemicals

Central Study Contacts

Rungsima Wanitphakdeedecha, MD

CONTACT

rungsima.wan@mahidol.ac.th

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2012

First Posted

December 27, 2012

Study Start

August 1, 2012

Primary Completion

December 1, 2012

Study Completion

August 1, 2013

Last Updated

December 27, 2012

Record last verified: 2012-08

Locations

TH(1)