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

This study is currently recruiting participants.
Verified August 2012 by Mahidol University
Sponsor:
Information provided by (Responsible Party):
Mahidol University
ClinicalTrials.gov Identifier:
NCT01756664
First received: December 20, 2012
Last updated: December 26, 2012
Last verified: August 2012
History of Changes
  Purpose

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


Condition Intervention
PIH
 Other: Sunscreen
Other: Vaseline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Use of Sunscreen Starting on the First Day After Ablative Fractional Skin Resurfacing - A Pilot Study.

Resource links provided by NLM:

MedlinePlus related topics: Sun Exposure
Drug Information available for: Petrolatum
U.S. FDA Resources

Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • Melanin Index [ Time Frame: 3 Month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Erythema Index [ Time Frame: 3 Months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Transepidermal Water Loss [ Time Frame: 1 Week ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: August 2012
Estimated Study Completion Date: August 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control
Vaseline has been used on the first day after laser treatment
 Other: Vaseline
Active Comparator: Sunscreen
Sunscreen has been used on the first day after laser treatment
 Other: Sunscreen

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
  • Lactation
  • Age < 18
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01756664

Contacts
Contact: Rungsima Wanitphakdeedecha, MD rungsima.wan@mahidol.ac.th

Locations
Thailand
Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University Recruiting
Bangkok, Thailand, 10700
Contact: Rungsima Wanitphakdeedecha, MD         rungsima.wan@mahidol.ac.th    
Principal Investigator: Rungsima Wanitphakdeedecha, MD            
Sponsors and Collaborators
Mahidol University
  More Information

No publications provided

Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT01756664     History of Changes
Other Study ID Numbers: Siriraj-Eucerin01, SI402/2012
Study First Received: December 20, 2012
Last Updated: December 26, 2012
Health Authority: Thailand: Ethical Committee

Additional relevant MeSH terms:
Petrolatum
Sunscreening Agents
Emollients
Dermatologic Agents
Therapeutic Uses
 Pharmacologic Actions
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013