ClinicalTrials.gg
CompletedNCT02492373Updated Jun 1, 2016

Topical Corticosteroids on the Incidence of Postinflammatory Hyperpigmentation After QsNdYAG Laser

An interventional study of topical 0.05% Clobetasol propionate ointment and Q switched Nd:YAG laser 532 nm in Lentigines and Post Inflammatory Hyperpigmentation, sponsored by Mahidol University. Completed at 1 site in Thailand. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-06-01.

Sponsored by Mahidol University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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.
02

Conditions studied

  • Lentigines
  • Post Inflammatory Hyperpigmentation

Keywords

  • Post inflammatory hyperpigmentation
  • topical high potency steroid
  • Qs NdYAG laser
03

In context

Lentigo

28 studies on the registry are indexed under Lentigo; 2 are open to participants now.

This study's enrollment of 21 is below the median of 30 across 25 interventional studies indexed under Lentigo.

Browse Lentigo studies →

Lead sponsor

Mahidol University is the lead sponsor of 747 studies on the registry; 119 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Having multiple lentigines on both sides of the face
  • Fitzpatrick skin phototype 3-5

Exclusion criteria

Exclusion Criteria:

  • Patients with lesions with any clinical suspicion of being pre-cancerous or skin 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, patients, history of vitiligo
  • Patients with unrealistic concerns/expectations and inability to do the appropriate post-operative care
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
21 participants (actual)

Study arms

  • Active comparator
    laser+steroid 2 days before and after laser

    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.

    Drug: topical 0.05% Clobetasol propionate ointment · Device: Q switched Nd:YAG laser 532 nm

  • Other
    laser+steroid 2 days after laser

    Controlled side. Applied topical 0.05% Clobetasol propionate ointment only 2 days after the laser treatment

    Drug: topical 0.05% Clobetasol propionate ointment · Device: Q switched Nd:YAG laser 532 nm

Interventions

  • Drugtopical 0.05% Clobetasol propionate ointment

    Apply only on the treated area twice a day as mentions

  • DeviceQ switched Nd:YAG laser 532 nm

    Treatment of facial lentigines. The energy using depends on the endpoint of immediate whitening of the lesions.

06

What researchers measure

Primary outcomes

  1. The incidence of post inflammatory hyperpigmentation

    By investigator's observation.

    Time frame: 2 weeks

Secondary outcomes

  1. Side effects of topical steroid

    By investigators' observation of telangiectasia, erythema or atrophy.

    Time frame: Follow-up 2, 3, 4, 8, 12 and 24 weeks after the last treatment

  2. 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

    Time frame: Follow-up 4, 8, 12 and 24 weeks after the last treatment

07

Study locations

1 site
  • Faculty of Medicine Siriraj Hospital, Mahidol University
    Bangkok, 10700, Thailand
08

References and documents

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 24292155 ↗
  • Ho 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 21384391 ↗
  • Takiwaki 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 7963648 ↗
  • Cheyasak 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 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2015, a primary completion of May 2016 and a completion of May 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 27, 2015
First posted
Jul 8, 2015
Start
Feb 2015
Primary completionActual
May 2016
CompletionActual
May 2016
Last update
Jun 1, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 1, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02492373
Lead sponsor
Mahidol University
Responsible party
Woraphong Manuskiatti, M.D. (Professor, Mahidol University) — Principal investigator
First posted
Jul 8, 2015
Start date
Feb 2015
Primary completion
May 2016
Completion
May 2016
Last update
Jun 1, 2016

Study contacts

Woraphong Manuskiatti, M.D.
principal investigator · Department of Dermatology, Siriraj Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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