PIHNCT01756664
The Use of Sunscreen Starting on the First Day After Ablative Fractional Skin Resurfacing
A study testing Sunscreen and Vaseline in people with PIH, run by Mahidol University at 1 site in Thailand.
Trial summary
The use of sunscreen on the first day after fractional ablative skin resurfacing may reduce the risk of post-inflammatory hyperpigmentation Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- PIH
- What is being tested?
- Sunscreen and Vaseline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteThailand
- Study dates
- Aug 2012to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who want to receive fractional ablative laser resurfacing for acne scars
Who cannot join
- Pregnancy
- Lactation
- Age < 18
Trial locations and contacts
1 site in 1 country.
Rungsima Wanitphakdeedecha, MD contact
Thailand1 site, 1 recruiting
- Recruiting
Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, 10700
Rungsima Wanitphakdeedecha, MD, rungsima.wan@mahidol.ac.th
Rungsima Wanitphakdeedecha, MD
About this study
Official title: The Use of Sunscreen Starting on the First Day After Ablative Fractional Skin Resurfacing - A Pilot Study.
- The use of sunscreen on the first day after fractional ablative skin resurfacing may reduce the risk of post-inflammatory hyperpigmentation
Read the 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.
- Conditions
- PIH
- Being tested
- Sunscreen, Vaseline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SunscreenOther
VaselineOther
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Vaseline has been used on the first day after laser treatment Receives: Other: Vaseline |
| Sunscreen | Active comparator | Sunscreen has been used on the first day after laser treatment Receives: Other: Sunscreen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Melanin Index
Measured: 3 Month
Secondary outcomes (1)
Erythema Index
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2012
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PIHStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01756664
- Sponsor's protocol ID
- Siriraj-Eucerin01
- Other IDs
- SI402/2012
- Status last verified
- Aug 2012
- First submitted
- 20 Dec 2012
- Last updated
- 27 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Sunscreen Starting on the First Day After Ablative Fractional Skin Resurfacing - A Pilot Study.
- ClinicalTrials.gov ID
- NCT01756664
- Acronym / sponsor ID
- Siriraj-Eucerin01
- Conditions
- PIH
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Aug 2013 (estimated)
- First posted
- 27 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: VaselineVaseline has been used on the first day after laser treatment |
| Sunscreen | Active comparator | Other: SunscreenSunscreen has been used on the first day after laser treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who want to receive fractional ablative laser resurfacing for acne scars
Key exclusion criteria (3 listed)
- Pregnancy
- Lactation
- Age < 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sunscreen | Other | Sunscreen |
| Vaseline | Other | Control |
Primary outcome
Melanin Index
Time frame: 3 Month
1 secondary outcome
Erythema Index
Time frame: 3 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rungsima Wanitphakdeedecha, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sunscreen and Vaseline in people with PIH, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rungsima Wanitphakdeedecha, MD (rungsima.wan@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Melanin Index (time frame: 3 Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2012.