Multiclear Treatment for Striae Distensae - A Pilot Study

Striae Distensae Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02126566
• Other study ID #: 2013/00518
• Status: Completed
• Phase: Phase 2
• First received: April 28, 2014
• Last updated: December 23, 2014
• Start date: July 2014
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: National University Hospital, Singapore
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Domain Specific Review Boards
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Striae Distensae

Intervention

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

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes