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Completed

NCT Number: NCT03858543

Fractional Laser Assisted Delivery of Sculptra® for the Treatment of Striae

This study evaluates the efficacy of treatment of striae distensae using the combined modality of fractional laser and poly-L lactic acid (Sculptra).

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Key information

Conditions

Striae Distensae Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Henry Ford Health System

Detroit, Michigan, 48202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Poly-L Lactic Acid

Drug

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.

Other names: Sculptra

Fractional laser treatment

Device

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.

Other names: Sciton Laser

Primary outcomes

  1. Change in Stretch Mark Size

    Time frame: 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 outcomes

  1. Treatments Superiority Assessment

    Time frame: 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.

  2. Treatments Superiority Assessment

    Time frame: 4 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.

  3. Treatments Superiority Assessment

    Time frame: 5 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.

  4. Treatments Superiority Assessment

    Time frame: 6 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.

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Collaborators

  • Galderma R&D

Registry information

Official study title

Fractional Laser Assisted Delivery of Sculptra® for the Treatment of Striae: FADeS Trial

Acronym: FADeS

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Feb 28, 2019
Registry last updated
Aug 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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