LentiginesNCT02492373
Topical Corticosteroids on the Incidence of Postinflammatory Hyperpigmentation After QsNdYAG Laser
A study testing topical 0.05% Clobetasol propionate ointment and Q switched Nd:YAG laser 532 nm in people with Lentigines and Post Inflammatory Hyperpigmentation, run by Mahidol University at 1 site in Thailand.
Trial summary
To investigate the benefit of the application of topical high potency steroid on the incidence of post inflammatory hyperpigmentation after laser treatment. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Lentigines, Post Inflammatory Hyperpigmentation
- What is being tested?
- topical 0.05% Clobetasol propionate ointment and Q switched Nd:YAG laser 532 nm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteThailand
- Study dates
- Feb 2015to May 2016
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Having multiple lentigines on both sides of the face
- Fitzpatrick skin phototype 3-5
Who cannot join
- Patients with lesions with any clinical suspicion of being pre-cancerous or skin malignancies of any kind
- Patients who have photosensitive dermatoses
- Pregnancy and lactation woman
- Patients with wound infections (herpes, other) on the day of treatment
- Patients with moderate and severe inflammatory acne, Immunosuppressed patients, history of vitiligo
- Patients with unrealistic concerns/expectations and inability to do the appropriate post-operative care
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Bangkok, 10700
About this study
Official title: Effect of Topical Corticosteroids on the Incidence of Postinflammatory Hyperpigmentation Following Q-switched Nd:YAG 532 nm Laser for Treatment of Facial Lentigines - A Pilot Study
To investigate the benefit of the application of topical high potency steroid on the incidence of post inflammatory hyperpigmentation after laser treatment.
Read the detailed description
- The incidence of post inflammatory hyperpigmentation (PIH) after treating lentigines with Q-switched Nd:YAG laser was 78.3%.
- It has been found that the incidence of PIH decreased to 40% after applied topical high potency steroid 2 days after the laser treatment.
- By these anti-inflammatory and anti-PIH effects of the high potency steroid, the investigators aimed that the application of steroid 2 days before and 2 days after the laser treatment would be better reduction in the incidence of PIH after Q-switched Nd:YAG laser.
- Conditions
- Lentigines, Post Inflammatory Hyperpigmentation
- Being tested
- topical 0.05% Clobetasol propionate ointment, Q switched Nd:YAG laser 532 nm
- Keywords
- Post inflammatory hyperpigmentation, topical high potency steroid, Qs NdYAG laser
- Medical subject headings
- Lentigo, Hyperpigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topical 0.05% Clobetasol propionate ointmentDrug
Apply only on the treated area twice a day as mentions
Q switched Nd:YAG laser 532 nmDevice
Treatment of facial lentigines. The energy using depends on the endpoint of immediate whitening of the lesions.
| Study group | Role | What they receive |
|---|---|---|
| laser+steroid 2 days before and after laser | Active comparator | Before lentigines' treatment with Qs Nd:YAG 532 nm laser, topical 0.05% Clobetasol propionate ointment was applied 2 days on the lesion. Then applied 2 days after the treatment. Receives: Drug: topical 0.05% Clobetasol propionate ointment; Device: Q switched Nd:YAG laser 532 nm |
| laser+steroid 2 days after laser | Other | Controlled side. Applied topical 0.05% Clobetasol propionate ointment only 2 days after the laser treatment Receives: Drug: topical 0.05% Clobetasol propionate ointment; Device: Q switched Nd:YAG laser 532 nm |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of post inflammatory hyperpigmentation
By investigator's observation.
Measured: 2 weeks
Secondary outcomes (2)
Side effects of topical steroid
By investigators' observation of telangiectasia, erythema or atrophy.
Measured: Follow-up 2, 3, 4, 8, 12 and 24 weeks after the last treatment
The patients satisfaction
By using Quartile grading scale of improvement; 0 = not improve, 1= 1-25% improvement, 2 = 26-50% improvement, 3 = 51-75% improvement and 4 = 76-100% improvement
Measured: Follow-up 4, 8, 12 and 24 weeks after the last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study startFeb 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for LentiginesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 21 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
- Investigators
- Woraphong Manuskiatti, M.D., Principal investigator, Department of Dermatology, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02492373
- Sponsor's protocol ID
- Si 033/2015
- Status last verified
- May 2016
- First submitted
- 27 Jun 2015
- Last updated
- 1 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jun HJ, Cho SH, Lee JD, Kim HS. A split-face, evaluator-blind randomized study on the early effects of Q-switched Nd:YAG laser plus Er:YAG micropeel (combined therapy) versus Q-switched Nd:YAG alone in light solar lentigines in Asians. Lasers Med Sci. 2014 May;29(3):1153-8. doi: 10.1007/s10103-013-1489-9. Epub 2013 Nov 29.
PubMed 24292155Ho SG, Yeung CK, Chan NP, Shek SY, Chan HH. A comparison of Q-switched and long-pulsed alexandrite laser for the treatment of freckles and lentigines in oriental patients. Lasers Surg Med. 2011 Feb;43(2):108-13. doi: 10.1002/lsm.21045.
PubMed 21384391Takiwaki H, Shirai S, Kohno H, Soh H, Arase S. The degrees of UVB-induced erythema and pigmentation correlate linearly and are reduced in a parallel manner by topical anti-inflammatory agents. J Invest Dermatol. 1994 Nov;103(5):642-6. doi: 10.1111/1523-1747.ep12398276.
PubMed 7963648Cheyasak N, Manuskiatti W, Maneeprasopchoke P, Wanitphakdeedecha R. Topical corticosteroids minimise the risk of postinflammatory hyper-pigmentation after ablative fractional CO2 laser resurfacing in Asians. Acta Derm Venereol. 2015 Feb;95(2):201-5. doi: 10.2340/00015555-1899.
PubMed 24854088
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Topical Corticosteroids on the Incidence of Postinflammatory Hyperpigmentation Following Q-switched Nd:YAG 532 nm Laser for Treatment of Facial Lentigines - A Pilot Study
- ClinicalTrials.gov ID
- NCT02492373
- Acronym / sponsor ID
- Si 033/2015
- Conditions
- Lentigines, Post Inflammatory Hyperpigmentation
- Keywords
- Post inflammatory hyperpigmentation, topical high potency steroid, Qs NdYAG laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 8 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.
To investigate the benefit of the application of topical high potency steroid on the incidence of post inflammatory hyperpigmentation after laser treatment.
Detailed description
- The incidence of post inflammatory hyperpigmentation (PIH) after treating lentigines with Q-switched Nd:YAG laser was 78.3%.
- It has been found that the incidence of PIH decreased to 40% after applied topical high potency steroid 2 days after the laser treatment.
- By these anti-inflammatory and anti-PIH effects of the high potency steroid, the investigators aimed that the application of steroid 2 days before and 2 days after the laser treatment would be better reduction in the incidence of PIH after Q-switched Nd:YAG laser.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laser+steroid 2 days before and after laser | Active comparator | Drug: topical 0.05% Clobetasol propionate ointment, Device: Q switched Nd:YAG laser 532 nmBefore lentigines' treatment with Qs Nd:YAG 532 nm laser, topical 0.05% Clobetasol propionate ointment was applied 2 days on the lesion. Then applied 2 days after the treatment. |
| laser+steroid 2 days after laser | Other | Drug: topical 0.05% Clobetasol propionate ointment, Device: Q switched Nd:YAG laser 532 nmControlled side. Applied topical 0.05% Clobetasol propionate ointment only 2 days after the laser treatment |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Having multiple lentigines on both sides of the face
- Fitzpatrick skin phototype 3-5
Key exclusion criteria (6 listed)
- Patients with lesions with any clinical suspicion of being pre-cancerous or skin malignancies of any kind
- Patients who have photosensitive dermatoses
- Pregnancy and lactation woman
- Patients with wound infections (herpes, other) on the day of treatment
- Patients with moderate and severe inflammatory acne, Immunosuppressed patients, history of vitiligo
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 |
|---|---|---|
| topical 0.05% Clobetasol propionate ointmentApply only on the treated area twice a day as mentions | Drug | laser+steroid 2 days after laser, laser+steroid 2 days before and after laser |
| Q switched Nd:YAG laser 532 nmTreatment of facial lentigines. The energy using depends on the endpoint of immediate whitening of the lesions. | Device | laser+steroid 2 days after laser, laser+steroid 2 days before and after laser |
Primary outcome
The incidence of post inflammatory hyperpigmentation
Time frame: 2 weeks
By investigator's observation.
2 secondary outcomes
Side effects of topical steroid
Time frame: Follow-up 2, 3, 4, 8, 12 and 24 weeks after the last treatment
The patients satisfaction
Time frame: Follow-up 4, 8, 12 and 24 weeks after the last 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 Jun 2016.
- Results publication: PubMed 24292155Jun HJ, Cho SH, Lee JD, Kim HS. A split-face, evaluator-blind randomized study on the early effects of Q-switched Nd:YAG laser plus Er:YAG micropeel (combined therapy) versus Q-switched Nd:YAG alone in light solar lentigines in Asians. Lasers Med Sci. 2014 May;29(3):1153-8. doi: 10.1007/s10103-013-1489-9. Epub 2013 Nov 29.
- Results publication: PubMed 21384391Ho SG, Yeung CK, Chan NP, Shek SY, Chan HH. A comparison of Q-switched and long-pulsed alexandrite laser for the treatment of freckles and lentigines in oriental patients. Lasers Surg Med. 2011 Feb;43(2):108-13. doi: 10.1002/lsm.21045.
- Results publication: PubMed 7963648Takiwaki H, Shirai S, Kohno H, Soh H, Arase S. The degrees of UVB-induced erythema and pigmentation correlate linearly and are reduced in a parallel manner by topical anti-inflammatory agents. J Invest Dermatol. 1994 Nov;103(5):642-6. doi: 10.1111/1523-1747.ep12398276.
- Results publication: PubMed 24854088Cheyasak N, Manuskiatti W, Maneeprasopchoke P, Wanitphakdeedecha R. Topical corticosteroids minimise the risk of postinflammatory hyper-pigmentation after ablative fractional CO2 laser resurfacing in Asians. Acta Derm Venereol. 2015 Feb;95(2):201-5. doi: 10.2340/00015555-1899.
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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.
Woraphong Manuskiatti, M.D. principal investigator
Department of Dermatology, Siriraj Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing topical 0.05% Clobetasol propionate ointment and Q switched Nd:YAG laser 532 nm in people with Lentigines and Post Inflammatory Hyperpigmentation, 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 2 inclusion and 6 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 Jun 2016. 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. 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?
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?
The incidence of post inflammatory hyperpigmentation (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02492373, which also lists 4 linked publications.
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 Jun 2016.