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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2012 by Mahidol University.
Recruitment status was:  Recruiting
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
  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
Intervention Model: Single Group Assignment
Masking: Double Blind (Participant, Care Provider, 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:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • Melanin Index [ Time Frame: 3 Month ]

Secondary Outcome Measures:
  • Erythema Index [ Time Frame: 3 Months ]

Other Outcome Measures:
  • Transepidermal Water Loss [ Time Frame: 1 Week ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT01756664     History of Changes
Other Study ID Numbers: Siriraj-Eucerin01
SI402/2012 ( Other Identifier: Faculty of Medicine Siriraj Hospital, Mahidol University )
Study First Received: December 20, 2012
Last Updated: December 26, 2012

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

ClinicalTrials.gov processed this record on June 23, 2017