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Ultherapy® for the Treatment of Acne Scars | Clinical Trials | Clareo Health

COMPLETEDNA

Ultherapy® for the Treatment of Acne Scars

Evaluation of the Ulthera® System for Correction of Moderate to Severe Atrophic Acne Scars

NCT02145364•Ulthera, Inc

Summary

This is a prospective, multi-site trial to be conducted at 2 clinical sites. Up to 20 subjects will receive study treatments. Following study treatments, follow-up visits will occur at 60, 90 and 180 days from each subject's last study treatment.

Detailed Description

Subjects with moderate to severe atrophic acne scars will be enrolled. Subjects will receive up to three dual-depth treatments to the cheek and temple areas impacted by acne scars, treating the number of treatment squares necessary to cover the area of scarring. Each treatment square will receive 30 lines per transducer depth for a total of 60 lines per treatment square. Three treatments 30 days apart will be required.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female, age 18 to 70 years.
•Subject in good health.
•Presence of moderate to severe atrophic acne scars on the cheeks and/or temples.
•Scars must be rolling and boxcar type scars predominantly, with few to no icepick scars present.
•Scars should be distensible with tension applied to skin.
•Subject must desire correction of his/her acne scarring as demonstrated by any level of dissatisfaction on baseline PSQ.
•Subjects of all Fitzpatrick skin types are eligible.
•Subject must be willing to withhold additional aesthetic therapies in the areas to be treated for the entire study duration if these treatments are judged by the investigator to potentially impact results.
•Willingness and ability to comply with protocol requirements, including returning for follow-up visits
•Willingness to maintain current skin care regimen and refrain from adding any new products or drugs for acne or acne scars for the duration of the study.
+4 more criteria

Exclusion Criteria

•Presence of an active systemic or local skin disease that may affect wound healing.
•Severe solar elastosis.
•Recent history of significant trauma to the face (\<6 months).
•Significant scarring, other than acne scars in area(s) to be treated.
•Open wounds or lesions in the area(s) to be treated.
•Severe or cystic active and clinically significant acne on the area(s) to be treated.
•Have a recent or current history of inflammatory skin disease, infection, cancerous/pre-cancerous lesion, unhealed wound in the proposed treatment areas.
•Have a history of systemic granulomatous diseases active or inactive or connective tissue disease.
•Have hypertrophic acne scars, any evidence of keloid scarring, predominantly icepick scarring (defined as more than half of all scar area in either the left or right or treatment area) or sinus tract scars.
•Presence of a metal stent or implant in the area(s) to be treated.
+25 more criteria

Locations (2)

Clinical Testing of Beverly Hills

Beverly Hills, California, United States

The Maas Clinic

San Francisco, California, United States

Key Dates

Start Date

May 1, 2014

Primary Completion Date

July 1, 2015

Completion Date

October 1, 2015

Last Updated

December 14, 2017

Enrollment

ACTUAL participants

Conditions

Acne ScarsAtrophic Acne Scars

Interventions

Ultherapy® treatment

DEVICE

Evaluation of Juläine (TM) for the Treatment of Atrophic Facial Acne Scars

NCT07058883

Acne Scars

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RECRUITINGNA

The Suitability of Tience® for Treating Acne Scars

NCT07368764

AcneAcne Scars

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RECRUITINGNA

Efficacy of Combined Fractional Er:Glass and Thulium Lasers Versus Microneedling for Atrophic Acne Scars

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 14, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Ultherapy® for the Treatment of Acne Scars

Inclusion Criteria

Exclusion Criteria

Evaluation of Juläine (TM) for the Treatment of Atrophic Facial Acne Scars

The Suitability of Tience® for Treating Acne Scars

Efficacy of Combined Fractional Er:Glass and Thulium Lasers Versus Microneedling for Atrophic Acne Scars

Feasibility Study to Collect and Assess Safety Data for a Radiofrequency Microneedling Device for Electrocoagulation and Hemostasis of Soft Tissues for Dermatologic Conditions

The MIRIA Acne Scar Study

Microneedling Combined With Either Tranexamic Acid or PRP in Treatment of Pigmented Postacne Scars