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Multiclear Treatment for Striae Distensae - A Pilot Study

Primary Purpose

Striae Distensae

Status
Completed
Phase
Phase 2
Locations
Singapore
Study Type
Interventional
Intervention
Administration of light therapy - measurement of results before and after therapy
Sponsored by
National University Hospital, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Striae Distensae focused on measuring striae distensiae

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm

Arm Description

Administration of light therapy - measurement of results before and after therapy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 28, 2014
Last Updated
December 23, 2014
Sponsor
National University Hospital, Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT02126566
Brief Title
Multiclear Treatment for Striae Distensae - A Pilot Study
Official Title
Phase 2 Study of Multiclear Treatment for Striae Distensae - A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National University Hospital, Singapore

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Striae Distensae
Keywords
striae distensiae

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Arm
Arm Type
Experimental
Arm Description
Administration of light therapy - measurement of results before and after therapy
Intervention Type
Device
Intervention Name(s)
Administration of light therapy - measurement of results before and after therapy
Primary Outcome Measure Information:
Title
Reduction in Striae
Description
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.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Both male and female subjects Patients above 21 years Patients who are able to attend follow up regularly Exclusion Criteria: Patients with other co-existing dermatoses Patients with epilepsy/ who are pregnant Patients with previous intolerable treatment to blue light Patients treated with blue light within the last six months
Facility Information:
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore

12. IPD Sharing Statement

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Multiclear Treatment for Striae Distensae - A Pilot Study

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