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 range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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