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

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ClinicalTrials.gov Identifier: NCT01756664
Recruitment Status : Unknown
Verified August 2012 by Mahidol University.
Recruitment status was:  Recruiting
First Posted : December 27, 2012
Last Update Posted : December 27, 2012
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
PIH Other: Sunscreen Other: Vaseline

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (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.
Study Start Date : August 2012
Primary Completion Date : December 2012
Estimated Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

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

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

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 )
First Posted: December 27, 2012    Key Record Dates
Last Update Posted: December 27, 2012
Last Verified: August 2012

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