CompletedNot Applicable

DA-13-007 Versus Sculptra for the Treatment of Nasolabial Folds Wrinkles

United States161 participantsStarted 2015-01

Plain-language summary

Study DA-13-007 is a randomized, evaluator-blinded, within subject (split face) multicenter clinical study of DA-13-007l (Injectable poly-l-lactic acid) compared to SCULPTRA in the treatment of nasolabial fold wrinkles. Qualifying subjects will be randomized to receive DA-13-007l and SCULPTRA on either the right or left side of the face.

Who can participate

Age range21 Years

SexALL

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Inclusion criteria

✓. A female is considered of childbearing potential unless she is
✓. Reliable methods of contraception are:

Exclusion criteria

✕. Pregnant (positive urine pregnancy test), are planning to become pregnant during the study period, have an infant they are breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control.
✕. Subjects planning a facial cosmetic procedure during the study period or with prior cosmetic procedures (i.e., surgery) or visible scars that may affect the evaluation of response and/or quality of photography.
✕. Facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin, or an inability to substantially lessen upper facial rhytids even by physically spreading them apart.
✕. Active skin disease within the treatment area within 6 months prior to study entry.
✕. History of malignancy, excluding non-melanoma skin cancer within the past 5 years.
✕. Profound atrophy/excessive weakness of muscles in target areas of injection.
✕. History of facial nerve palsy.
✕. Facial wrinkles therapy, such a permanent or enduring dermal fillers in the previous 2 years or bioresorbable during the previous 12 months.

What they're measuring

Efficacy of treatment vs Comparator (using a 5-grade WSRS (wrinkle severity rating scale) score and a rating by an independent evaluator)

Timeframe: One Year

Trial details

NCT IDNCT02310490

SponsorDermAvance

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-12

View on ClinicalTrials.gov More Face; Atrophy trials