Striae Distensae Clinical Trial
Official title:
Efficacy of Short Pulsed 1064 nm Nd-YAG Laser Versus 10600 nm Fractional CO2 Laser in Treatment of Striae Alba: A Randomized Clinical Trial
Striae alba is a clinical variant of striae distensae characterized by focal dermal collagen loss and thinning of elastic fibers. Carbon dioxide (CO2) laser is an ablative laser modality that ablates defective collagen and stimulates new collagen formation. Neodymium-Doped Yttrium Aluminum Garnet (Nd-YAG) laser is a non ablative modality that results in stimulation of collagen formation through dermal heating. High frequency skin ultrasound is a rapid and non-invasive tool for measurement f skin thickness and can be used for this purpose.
Status | Recruiting |
Enrollment | 31 |
Est. completion date | December 31, 2021 |
Est. primary completion date | October 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years to 50 Years |
Eligibility | Inclusion Criteria: - Patients with striae alba. - Ages between 14 years - 50 years. - Both sexes. - Skin types I-IV - Bilateral striae. Exclusion Criteria: - Patients with striae rubra, striae nigra, striae caerulea or striae atrophicans. - History of diseases associated with SD (cushing disease or Marfan syndrome). - History of drugs associated with development of SD (topical or systemic glucocorticoids, Indinavir or protease inhibitors). - History of conditions with abnormal dermal connective tissue structure (Ehler-Danlos syndrome, cutis laxa, pseudoxanthoma elasticum, elastolysis, elastomas, hyaline fibromatosis, keloidal tendencies, skin atrophy, poikiloderma or anetoderma). - Current state of pregnancy in female patients. - Relative contraindications to laser therapy (photosensitive dermatoses or burns). - History of any therapeutic procedure for striae in the past 6 months before enrollment in the study. - History of conditions associated with dermal edema or lymphedema. |
Country | Name | City | State |
---|---|---|---|
Egypt | Cairo University | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
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Fatemi Naeini F, Behfar S, Abtahi-Naeini B, Keyvan S, Pourazizi M. Promising Option for Treatment of Striae Alba: Fractionated Microneedle Radiofrequency in Combination with Fractional Carbon Dioxide Laser. Dermatol Res Pract. 2016;2016:2896345. doi: 10.1155/2016/2896345. Epub 2016 Mar 16. — View Citation
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Lee SE, Kim JH, Lee SJ, Lee JE, Kang JM, Kim YK, Bang D, Cho SB. Treatment of striae distensae using an ablative 10,600-nm carbon dioxide fractional laser: a retrospective review of 27 participants. Dermatol Surg. 2010 Nov;36(11):1683-90. doi: 10.1111/j.1524-4725.2010.01719.x. Epub 2010 Sep 14. — View Citation
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* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment of the efficacy and therapeutic superiority of both laser machines by measuring both clinical improvement using modified Davey's score and visually by measuring different skin thickness planes using high frequency skin ultrasound | Assessment of the efficacy and therapeutic superiority of either 1064 nm Nd-YAG laser or 10600 nm fractional CO2 laser as treatment modalities for patients with striae alba guided by investigated dermal changes obtained by high frequency skin ultrasound machine, namely: dermal thickness, sub epidermal low echogenicity band thickness and epidermal thickness, both before and after treatment with both laser machines. Statistical analysis of outcome data shall be carried out to determine significance of efficacy of one laser modality over the other. | 20 - 24 months | |
Secondary | Treating and improving lesions of striae alba for 25 patients included in the sample size using both laser machines, one on each side in a rate of one session per month for four months duration | Treating and improving lesions of striae alba for all of the 25 patients included in the sample using short pulsed 1064 nm Nd-YAG laser and 10600 nm fractional CO2 laser each on one side of the area affected, for four successive sessions with one month interval. The degree of improvement shall be determined through comparing modified Davey's score both before and after treatment sessions. | 20 - 24 months |
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