Hypertrophic ScarsPhase 4NCT02487212
Treatment of Hypertrophic Scars Using Fractional Laser and Fractional Laser-assisted Topical Corticosteroid Delivery
A Phase 4 study testing 0.05% Clobetasol propionate, Petrolatum gel and Fractional Erbium:Yag (2,940-nm) laser in people with Hypertrophic Scars, run by Mahidol University at 1 site in Thailand.
Trial summary
The objective of this study is to evaluate the efficacy and safety of using ablative fractional laser- assisted topical corticosteroid delivery for the treatment of hypertrophic scar. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertrophic Scars
- What is being tested?
- 0.05% Clobetasol propionate, Petrolatum gel and Fractional Erbium:Yag (2,940-nm) laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteThailand
- Study dates
- Apr 2014to May 2015
- Phase
- Phase 4
- 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 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female subjects with age range 18-60 years;
- Subject with hypertrophic scar from abdominal surgery for at least 3 months;
- Discontinued using oral isotretinoin for 6 months, alpha hydroxy acid or topical retinoic acid for 3 months
Who cannot join
- Subject who has skin Infection, photosensitive dermatosis or inflammatory acne on the treated area;
- Subject who smoke cigarette;
- Subject who was treated with Intralesional corticosteroid
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, 10700
About this study
The objective of this study is to evaluate the efficacy and safety of using ablative fractional laser- assisted topical corticosteroid delivery for the treatment of hypertrophic scar.
Read the detailed description
Hypertrophic scars are common conditions that cause persistent symptom and can lead to severe psychosocial impairment. Intralesional corticosteroid have been a mainstay in the treatment of hypertrophic scars. However, there are many disadvantages of corticosteroid injection such as severe pain, skin atrophy, skin thinning, steroid acne, telangiectasia and hypopigmentation.
Recent reports propose new treatment methods for hypertrophic scars with the use of fractional ablative lasers to create zones of ablation of the skin that may assisted the penetration of drugs to the skin.
- Conditions
- Hypertrophic Scars
- Being tested
- 0.05% Clobetasol propionate, Petrolatum gel, Fractional Erbium:Yag (2,940-nm) laser
- Keywords
- fractional laser, hypertrophic scar, topical corticosteroid, laser assisted delivery systems
- Medical subject headings
- Cicatrix, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.05% Clobetasol propionateDrug
0.05% Clobetasol propionate was rubbed for 2 minutes on one side of the scar immediately after treated with fractional Erbium: YAG (2,940-nm) laser. The treatment was done in every 2 weeks for 4 sessions
Petrolatum gelDrug
Petrolatum gel was rubbed for 2 minutes on the other side of the scar immediately after treated with fractional Erbium: YAG (2,940-nm) laser.The treatment was done in every 2 weeks for 4 sessions
Fractional Erbium:Yag (2,940-nm) laserDevice
The parameter of the laser was 28 J/cm2, 5% spot density, 1 pass for the whole scar. The treatment was done in every 2 weeks for 4 sessions
| Study group | Role | What they receive |
|---|---|---|
| Laser+Topical corticosteroid | Active comparator | Hypertrophic scars were treated with fractional Erbium: Yttrium aluminium garnet (YAG) (2,940-nm) laser, then 0.05% Clobetasol propionate ointment was immediately applied on the perforated scar on one side Receives: Drug: 0.05% Clobetasol propionate; Device: Fractional Erbium:Yag (2,940-nm) laser |
| Laser+Petrolatum gel | Placebo comparator | Hypertrophic scars were treated with fractional Erbium: YAG (2,940-nm) laser, then topical petrolatum gel was immediately applied on the perforated scar on the other side Receives: Drug: Petrolatum gel; Device: Fractional Erbium:Yag (2,940-nm) laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scar thickness measured by digital calliper
Measured: change from baseline in scar thickness at 6 months
Secondary outcomes (1)
Patient and observer scar assessment scale
Measured: Baseline, 1 month after first treatment, 1,3 and 6 months after fourth treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startApr 2014
- Primary completionApr 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic ScarsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Woraphong Manuskiatti, M.D., Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02487212
- Sponsor's protocol ID
- 614/2556 (EC2)
- Status last verified
- Jun 2015
- First submitted
- 11 Apr 2015
- Last updated
- 1 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Hypertrophic Scars Using Fractional Laser and Fractional Laser-assisted Topical Corticosteroid Delivery
- ClinicalTrials.gov ID
- NCT02487212
- Acronym / sponsor ID
- 614/2556 (EC2)
- Conditions
- Hypertrophic Scars
- Keywords
- fractional laser, hypertrophic scar, topical corticosteroid, laser assisted delivery systems
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 1 Jul 2015 (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 objective of this study is to evaluate the efficacy and safety of using ablative fractional laser- assisted topical corticosteroid delivery for the treatment of hypertrophic scar.
Detailed description
Hypertrophic scars are common conditions that cause persistent symptom and can lead to severe psychosocial impairment. Intralesional corticosteroid have been a mainstay in the treatment of hypertrophic scars. However, there are many disadvantages of corticosteroid injection such as severe pain, skin atrophy, skin thinning, steroid acne, telangiectasia and hypopigmentation.
Recent reports propose new treatment methods for hypertrophic scars with the use of fractional ablative lasers to create zones of ablation of the skin that may assisted the penetration of drugs to the skin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser+Topical corticosteroid | Active comparator | Drug: 0.05% Clobetasol propionate, Device: Fractional Erbium:Yag (2,940-nm) laserHypertrophic scars were treated with fractional Erbium: Yttrium aluminium garnet (YAG) (2,940-nm) laser, then 0.05% Clobetasol propionate ointment was immediately applied on the perforated scar on one side |
| Laser+Petrolatum gel | Placebo comparator | Drug: Petrolatum gel, Device: Fractional Erbium:Yag (2,940-nm) laserHypertrophic scars were treated with fractional Erbium: YAG (2,940-nm) laser, then topical petrolatum gel was immediately applied on the perforated scar on the other side |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female subjects with age range 18-60 years;
- Subject with hypertrophic scar from abdominal surgery for at least 3 months;
- Discontinued using oral isotretinoin for 6 months, alpha hydroxy acid or topical retinoic acid for 3 months
Key exclusion criteria (3 listed)
- Subject who has skin Infection, photosensitive dermatosis or inflammatory acne on the treated area;
- Subject who smoke cigarette;
- Subject who was treated with Intralesional corticosteroid
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 |
|---|---|---|
| 0.05% Clobetasol propionate0.05% Clobetasol propionate was rubbed for 2 minutes on one side of the scar immediately after treated with fractional Erbium: YAG (2,940-nm) laser. The treatment was done in every 2 weeks for 4 sessions | Drug | Laser+Topical corticosteroid |
| Petrolatum gelPetrolatum gel was rubbed for 2 minutes on the other side of the scar immediately after treated with fractional Erbium: YAG (2,940-nm) laser.The treatment was done in every 2 weeks for 4 sessions | Drug | Laser+Petrolatum gel |
| Fractional Erbium:Yag (2,940-nm) laserThe parameter of the laser was 28 J/cm2, 5% spot density, 1 pass for the whole scar. The treatment was done in every 2 weeks for 4 sessions | Device | Laser+Petrolatum gel, Laser+Topical corticosteroid |
Primary outcome
Scar thickness measured by digital calliper
Time frame: change from baseline in scar thickness at 6 months
1 secondary outcome
Patient and observer scar assessment scale
Time frame: Baseline, 1 month after first treatment, 1,3 and 6 months after fourth treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 0.05% Clobetasol propionate, Petrolatum gel and Fractional Erbium:Yag (2,940-nm) laser in people with Hypertrophic Scars, 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 3 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: finished, as of the sponsor's last update on 1 Jul 2015. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scar thickness measured by digital calliper (time frame: change from baseline in scar thickness at 6 months). 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 1 Jul 2015.