NCT02492373

Brief Summary

To investigate the benefit of the application of topical high potency steroid on the incidence of post inflammatory hyperpigmentation after laser treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 8, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

June 1, 2016

Status Verified

May 1, 2016

Enrollment Period

1.2 years

First QC Date

June 27, 2015

Last Update Submit

May 31, 2016

Conditions

LentiginesPost Inflammatory Hyperpigmentation

Keywords

Post inflammatory hyperpigmentationtopical high potency steroidQs NdYAG laser

Outcome Measures

Primary Outcomes (1)

  • The incidence of post inflammatory hyperpigmentation

    By investigator's observation.

    2 weeks

Secondary Outcomes (2)

  • Side effects of topical steroid

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

  • The patients satisfaction

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

Study Arms (2)

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.

Drug: topical 0.05% Clobetasol propionate ointmentDevice: 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

Drug: topical 0.05% Clobetasol propionate ointmentDevice: Q switched Nd:YAG laser 532 nm

Interventions

topical 0.05% Clobetasol propionate ointmentDRUG

Apply only on the treated area twice a day as mentions

laser+steroid 2 days after laserlaser+steroid 2 days before and after laser
Q switched Nd:YAG laser 532 nmDEVICE

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

laser+steroid 2 days after laserlaser+steroid 2 days before and after laser

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, Bangkok, 10700, Thailand

Location

Related Publications (4)

  • 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.

    PMID: 24292155RESULT

  • 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.

    PMID: 21384391RESULT

  • 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.

    PMID: 7963648RESULT

  • 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.

    PMID: 24854088RESULT

MeSH Terms

Conditions

LentigoHyperpigmentation

Condition Hierarchy (Ancestors)

MelanosisPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Woraphong Manuskiatti, M.D.

    Department of Dermatology, Siriraj Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 27, 2015

First Posted

July 8, 2015

Study Start

February 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

June 1, 2016

Record last verified: 2016-05

Locations

TH(1)