usefulness of IPL in treating melasma

Completed

Conditions: Patients with Melasma

Registration Number: CTRI/2017/08/009529

Lead Sponsor: IPGMER and SSKM HOSPITAL

Brief Summary: EVALUATION OF EFFICACY AND SAFETY PROFILE OF INTENSE PULSED LIGHT TREATMENT IN MELASMA

Melasma is an acquired pigmentary disorder characterized by brownish hyperpigmented macules usually on the face. Majority of the cases are seen in women. The exact pathogenesis of melasma is unknown. It is believed to occur due to combination of various factors such as sun-exposure, hormonal factors (pregnancy and oral contraceptive pills), genetic predisposition and drugs like phenytoin.

The recurrent and refractory nature of this condition makes it difficult for treatment. Current treatment options include medical treatment [triple combination therapy ,tranexemic acid, hydroquinone, arbutin & glabridin] and cosmetic treatment including chemical peeling. However the treatments available are often found to be ineffective or only partially effective. Even the side effects of most treatments were found to be very high especially when used for longer duration. In this context, the advent of Lasers and IPL offers new scope for the treatment of this recalcitrant condition.

Recent studies have shown, that IPL can be an effective treatment option for for melasma and other pigment disorders though very few reports are available in Indian patients.In view of the above discussion, we propose to conduct a study to evaluate the efficacy and side effect profile of IPL in the treatment of MELASMA

**AIMS AND OBJECTIVES**

**Primary Objective:**

1.      To study the efficacy of use of IPL in the treatment of Melasma in Indian patients.

**Secondary Objectives:**

1.      To study the side effects of IPL on the darker skin types patients while being used for the treatment of melasma

2.      To study clinical types of Melasma attending our Out Patient Department.

3.      To study clinical and epidemiological associations of melasma.

**MATERIALS AND METHODS**

**STUDY AREA:** The proposed study will be institution based, conducted at the dermatology Out Patient Department (OPD) and Laser Procedure Room at Department of Dermatology, I.P.G.M.E.R & S.S.K.M. Hospital, Kolkata, a super-specialty tertiary center of eastern India.

**STUDY POPULATION:** All patients attending dermatology OPD will be screened and enrolled as per the inclusion criteria.

**STUDY PERIOD:** the proposed study will be carried out over a period of 18 months

**SAMPLE DESIGN:** Patients of melasma presenting to our OPD will be included in the study after thorough clinical evaluation

**CONTROLS:** Will not be included.

**PROCEDURE:**

Once enrolled patients will be treated by IPL once in every 4 weeks for 6 sessions. Pulse duration, Fluence, Pulse Count will be decided and adjusted according to the type of the lesion, patientâ€™s skin type, area of involvement and patientâ€™s reaction to the therapy.

Patient will be evaluated for the improvement and side effect if any at every session and. However observations at baseline, after 3rd session and after 6 session will be studied for statistical analysis to assess the efficacy. MASI score and Melanin index will be done at baseline, after 3rd session and after 6th sessions for statistical calculations of efficacy. Also Physicianâ€™s global assessment index will be used for assessment of efficacy.

**PLAN FOR STATISTICAL ANALYSIS OF DATA:** Data will be analyzed by appropriate statistical tests using statistical software SPSS version 6.0**.**

{ "SUMMARY OF FINDINGS/RESULT"- 1)females outnumber males in disease prevalence. 2)malar is most common clinical type. 3) improvement was seen only in few patients. 4) no permanent side effects were noted. }

{ "CONCLUSION"- IPL should not be used as first line therapy for melasma and should be reserved for only those patients who have failed to respond to conventional therapy.}

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 30

Inclusion Criteria

1.cases of melasma attending OPD consenting to participate in study through written informed consent.
2.patient above 18 years of age.

Exclusion Criteria

1.patient unable or unwilling to give consent.
2.patient with unrealistic expectation.
3.patient with active infection,SLE,pregnancy or on photosensitive mediacation.
4.patient on other form of treatment for melasma.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
improvement of melasma assessed by clinician global index.	12 months

Secondary Outcome Measures

Name	Time	Method
skin rejuvination	12 months

Trial Locations

Locations (1): I.P.G.M.E.R & SSKM Hospital, kolkata
🇮🇳
Kolkata, WEST BENGAL, India
I.P.G.M.E.R & SSKM Hospital, kolkata
🇮🇳Kolkata, WEST BENGAL, India
Nishant Choudhary
Principal investigator
08017065953
bugs.nic@gmail.com