Striae Distensae Clinical Trial
Official title:
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.
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.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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