Multiclear Treatment for Striae Distensae - A Pilot Study

NCT02126566 | Completed Phase 2

• 1 other identifier: 2013/00518
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Striae Distensae

Keywords

striae distensiae

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Single Arm

EXPERIMENTAL

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

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

Interventions

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

Single Arm

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both male and female subjects
• Patients above 21 years
• Patients who are able to attend follow up regularly

You may not qualify if:

• 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

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital

Singapore, Singapore, 119074, Singapore

Location

MeSH Terms

Conditions

Striae Distensae

Condition Hierarchy (Ancestors)

Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2014
• First Posted: April 30, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 24, 2014

Record last verified: 2014-12

Locations

SG (1)