Clinical trial NCT02492373: 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
Overall status: COMPLETED
Phase: NA
Conditions: Lentigines
Post Inflammatory Hyperpigmentation
Keywords: Post inflammatory hyperpigmentation
topical high potency steroid
Qs NdYAG laser
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2015-07-08
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The incidence of post inflammatory hyperpigmentation
timeFrame: 2 weeks
Secondary outcomes:
measure: Side effects of topical steroid
timeFrame: Follow-up 2, 3, 4, 8, 12 and 24 weeks after the last treatment
measure: The patients satisfaction
timeFrame: Follow-up 4, 8, 12 and 24 weeks after the last treatment
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital, Mahidol University
Study officials:
affiliation: Department of Dermatology, Siriraj Hospital
name: Woraphong Manuskiatti, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.