Striae Distensae
Conditions
Keywords
Stretch marks, Fractional laser therapy, Poly-L lactic acid, Sculptra
Brief summary
This study evaluates the efficacy of treatment of striae distensae using the combined modality of fractional laser and poly-L lactic acid (Sculptra).
Detailed description
Striae Distensae (SD) is a form of scarring that can oftentimes be quite disfiguring and emotionally distressing to individuals. Fractional laser therapy has been used by doctors to treat stretch marks by stimulating collagen growth. Poly-L lactic acid also promotes collagen growth in the areas injected. The combination of laser and poly-L lactic acid might provide the optimal treatment modality for SD by decreasing the appearance of atrophic scars.
Interventions
DRUGPoly-L Lactic Acid
After initial treatment, reassessment will be conducted at 3 follow-up visits. Photographs will be taken for blinded evaluators to compare post-treatment to the original pre-treatment photographs. At final visit, a questionnaire will be administered to rate treatment satisfaction.
After initial treatment, reassessment will be conducted at 3 follow-up visits. Photographs will be taken for blinded evaluators to compare post-treatment to the original pre-treatment photographs. At final visit, a questionnaire will be administered to rate treatment satisfaction.
Sponsors
Galderma R&D
Henry Ford Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject has bilateral striae alba * Subject has stable body weight for at least 6 months with Fitzpatrick skin type 1-4
Exclusion criteria
* Subject has striae rubra * Pregnant * History of adverse effects to phototherapy * Subject has single sided lesions * Subject has immunosuppression * Subject has radiation therapy to the study area * Subject has topical or oral steroid use or chemotherapy within the last 6 months * History of keloids or hypertrophic scar
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Stretch Mark Size | Baseline (Pre-treatment) vs. 3 Months, 4 Months, 5 Months, 6 Months | Modified Manchester Scar Scale was used to assess stretch mark reduction compared to pre-treatment photographs. The range of each subscale is between 4-26. A higher value represents a worse outcome. A value of 26 is the maximum score and represents the worst outcome. A value of 4 is the minimum score and represents the best outcome. Subscales are then summed to compute a total score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatments Superiority Assessment | 3 Months | Modified Manchester Scar Scale was used to assess and judge whether erbium-YAG fractionated laser therapy plus Sculptra is superior to laser therapy alone. The range of each subscale is between 4-26. A higher value represents a worse outcome. A value of 26 is the maximum score and represents the worst outcome. A value of 4 is the minimum score and represents the best outcome. Subscales are then summed to compute a total score. |
Countries
United States
Outcome results
None listed