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Topical Corticosteroids on the Incidence of Postinflammatory Hyperpigmentation After QsNdYAG Laser

Primary Purpose

Lentigines, Post Inflammatory Hyperpigmentation

Status

Completed

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

topical 0.05% Clobetasol propionate ointment

Q switched Nd:YAG laser 532 nm

About this trial

This is an interventional treatment trial for Lentigines focused on measuring Post inflammatory hyperpigmentation, topical high potency steroid, Qs NdYAG laser

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Faculty of Medicine Siriraj Hospital, Mahidol University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

laser+steroid 2 days before and after laser

laser+steroid 2 days after laser

Arm Description

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.

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

Outcomes

Primary Outcome Measures

The incidence of post inflammatory hyperpigmentation

By investigator's observation.

Secondary Outcome Measures

Side effects of topical steroid

By investigators' observation of telangiectasia, erythema or atrophy.

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

Full Information

NCT ID

NCT02492373

First Posted

June 27, 2015

Last Updated

May 31, 2016

Sponsor

Mahidol University

1. Study Identification

Unique Protocol Identification Number

NCT02492373

Brief Title

Topical Corticosteroids on the Incidence of Postinflammatory Hyperpigmentation After QsNdYAG Laser

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Completed

Study Start Date

February 2015 (undefined)

Primary Completion Date

May 2016 (Actual)

Study Completion Date

May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mahidol University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lentigines, Post Inflammatory Hyperpigmentation

Keywords

Post inflammatory hyperpigmentation, topical high potency steroid, Qs NdYAG laser

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

laser+steroid 2 days before and after laser

Arm Type

Active Comparator

Arm Description

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.

Arm Title

laser+steroid 2 days after laser

Arm Type

Other

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

topical 0.05% Clobetasol propionate ointment

Intervention Description

Apply only on the treated area twice a day as mentions

Intervention Type

Device

Intervention Name(s)

Q switched Nd:YAG laser 532 nm

Intervention Description

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

Primary Outcome Measure Information:

Title

The incidence of post inflammatory hyperpigmentation

Description

By investigator's observation.

Time Frame

2 weeks

Secondary Outcome Measure Information:

Title

Side effects of topical steroid

Description

By investigators' observation of telangiectasia, erythema or atrophy.

Time Frame

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

Title

The patients satisfaction

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Having multiple lentigines on both sides of the face Fitzpatrick skin phototype 3-5 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Woraphong Manuskiatti, M.D.

Organizational Affiliation

Department of Dermatology, Siriraj Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Faculty of Medicine Siriraj Hospital, Mahidol University

City

Bangkok

ZIP/Postal Code

10700

Country

Thailand

12. IPD Sharing Statement

Citations:

PubMed Identifier

24292155

Citation

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.

Results Reference

result

PubMed Identifier

21384391

Citation

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.

Results Reference

result

PubMed Identifier

7963648

Citation

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.

Results Reference

result

PubMed Identifier

24854088

Citation

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.

Results Reference

result

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Topical Corticosteroids on the Incidence of Postinflammatory Hyperpigmentation After QsNdYAG Laser

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