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NCT02955381
Restylane Silk Acne Scar Efficacy Evaluation Study
NA trial testing Restylane Silk, 1.0 ml in Acne in 26 participants. Terminated before completion.
18 April 2019
Quick facts
| Lead sponsor | Schweiger Dermatology, PLLC |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 26 |
| Start date | 28 March 2017 |
| Primary completion | 18 April 2019 |
| Estimated completion | 18 April 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Restylane Silk, 1.0 ml
- Saline, 1.0 ml
Conditions studied
- Acne — all drugs for Acne →
- Acne Scars — all drugs for Acne Scars →
- AdverseEvent — all drugs for AdverseEvent →
Sponsor
Schweiger Dermatology, PLLC
Who can join
Adults 22 to 55, any sex, with Acne or Acne Scars. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Randomized, double-blind, placebo-controlled, research pilot study. 30 subjects aged 22-55 years old of all skin types will be asked to sign an informed consent form prior to any study procedures. Subjects must have at least 1 but up to 3 acne scars ≥3 mm or ≤ 10 mm located on the cheeks or forehead. Subjects will receive one treatment (Restylane® Silk or Placebo) in each scar at day 0, and Month 1 (2 total treatments per scar during the study). Subjects will be asked to come to 10 visits: Screening visit (up to 35 days prior to Baseline), Baseline (Day 0), Day 7, Day 14, Month 1, Month 2, Month 3, Month 4, Month 5, and Month 6 (study exit visit). The treatment area will be evaluated at each visit by the unblinded investigator regarding erythema, bruising, inflammation, itching, stinging/burning, brightness, fullness, smoothness, and clarity. Safety and adverse events will be captured at each visit only by the unblinded investigator.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02955381
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02955381 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Schweiger Dermatology, PLLC
- Last refreshed: 10 May 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02955381.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing