Multiclear Treatment for Striae Distensae - A Pilot Study

NCT ID: NCT02126566

Last Updated: 2014-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2014-12-31

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.

Conditions

Striae Distensae

Keywords

striae distensiae

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Arm

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

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National University Hospital, Singapore

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National University Hospital

Singapore, Singapore, Singapore

Countries

Singapore

Other Identifiers

2013/00518

Identifier Type: -

Identifier Source: org_study_id