Multiclear Treatment for Striae Distensae - A Pilot Study

Phase 2 Study of Multiclear Treatment for Striae Distensae - A Pilot Study

Striae distensae is a common skin condition that rarely causes significant medical problems. However, it often results in a considerable amount of distress to those with the condition. Various modalities of treatments have been used for striae distensae but few have led to satisfactory results.

More recently, newer techniques such as pulsed dye laser and radiofrequency devices have been used with modest results. There is still, however, paucity of data using light therapy for the treatment of this condition. Blue light therapy using the Multiclear device has been used successfully in the treatment of acne. In contrast, there is little data to suggest its use in the management of striae distensae.

We aim to study the effects of blue light on the treatment of striae distensae and whether this can be used safely to manage this condition.

Study Overview

• Status: Completed
• Conditions: Striae Distensae
• Intervention / Treatment: Device: Administration of light therapy - measurement of results before and after therapy

Detailed Description

Patients will receive twice weekly blue light treatment with the Multiclear device. The first treatment dose will be 75mJ/cm2 ( Minimum Effective Dose;MED) for all patients. If no erythema develops, the subsequent treatment dose can be increased by 0.5 MED. If mild to moderate erythema develops, the same dose (i.e. 1 MED) will be used.If severe erythema/ blisters develop, treatment will be stopped and the patient wil be invited one week later and treatment will be offered at 50% of the last dose.

During the first consultation, patients will be assessed for the presence of striae distensae (SD). Duration and previous treatments of SD will be recorded. The width of the widest striae and the length of the longest straie will be measured at baseline and after 2 months of treatment. Photographs will be taken at baseline and post treatment. These will be evaluated by dermatologists who will be blinded (i.e. details of which photographs are pre or post treatment will not be given). Subjective scores will be used (Very good to excellent; >75%, Good; 51-75%, Moderate; 26-50%, Minimal to no improvement; <25%) Participants will also be given a feedback form to rate any improvements noted and any side effects experienced.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 2

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 119074
    • National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Both male and female subjects
2. Patients above 21 years
3. Patients who are able to attend follow up regularly

Exclusion Criteria:

1. Patients with other co-existing dermatoses
2. Patients with epilepsy/ who are pregnant
3. Patients with previous intolerable treatment to blue light
4. Patients treated with blue light within the last six months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Arm; Administration of light therapy - measurement of results before and after therapy	Device: Administration of light therapy - measurement of results before and after therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in Striae	The width of the widest striae and the length of the longest straie will be measured at baseline and after 2 months of treatment. Photographs will be taken at baseline and post treatment. These will be evaluated by dermatologists who will be blinded (i.e. details of which photographs are pre or post treatment will not be given). Subjective scores will be used (Very good to excellent; >75%, Good; 51-75%, Moderate; 26-50%, Minimal to no improvement; <25%) Participants will also be given a feedback form to rate any improvements noted and any side effects experienced.	2 months

Collaborators and Investigators

• Sponsor: National University Hospital, Singapore

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: April 28, 2014
• First Submitted That Met QC Criteria: April 29, 2014
• First Posted (Estimate): April 30, 2014

Study Record Updates

• Last Update Posted (Estimate): December 24, 2014
• Last Update Submitted That Met QC Criteria: December 23, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: striae distensiae
• Additional Relevant MeSH Terms: Skin Manifestations; Striae Distensae
• Other Study ID Numbers: 2013/00518