Topical Corticosteroids on the Incidence of Postinflammatory Hyperpigmentation After QsNdYAG Laser

Post Inflammatory Hyperpigmentation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02492373
• Other study ID #: Si 033/2015
• Status: Completed
• Phase: N/A
• First received: June 27, 2015
• Last updated: May 31, 2016
• Start date: February 2015
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperpigmentation
• Lentigines
• Lentigo
• Post Inflammatory Hyperpigmentation

Intervention

Drug:
• topical 0.05% Clobetasol propionate ointment
Apply only on the treated area twice a day as mentions

Device:
• Q switched Nd:YAG laser 532 nm
Treatment of facial lentigines. The energy using depends on the endpoint of immediate whitening of the lesions.

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (4)

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: — View 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. — View 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. 201 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of post inflammatory hyperpigmentation	By investigator's observation.	2 weeks	Yes
Secondary	Side effects of topical steroid	By investigators' observation of telangiectasia, erythema or atrophy.	Follow-up 2, 3, 4, 8, 12 and 24 weeks after the last treatment	Yes
Secondary	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	Follow-up 4, 8, 12 and 24 weeks after the last treatment	Yes