NCT01257555

Completed

Evaluation of a Photopneumatic System for the Treatment of A...

Solta Medical Source

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Other study identifiers

Sponsor study identifier

10-116-CF-I

Study Type

observational

Estimated enrollment

24

Locations

1 country

Sites

1

Timeline

Study Start

December 2010

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

September 2011

Actual (reported)

Study Completion

September 2011

Actual (reported)

Brief Summary

The purpose of the study is to evaluate the safety and efficacy of a photopneumatic therapy for the treatment of acne and concomitant symptoms associated with the disease, including erythema.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Estimated enrollment: 24 participants
Study completion date: September 2011
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
December 2010
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
December 8, 2010
Actual (reported)
First Posted
December 9, 2010
Actual (reported)
Primary Completion
September 2011
Actual (reported)
Study Completion
September 2011
Actual (reported)

Last Updated: March 26, 2012
Status Verified: March 2012
Last Update Submitted: March 22, 2012

Conditions

Mild to Moderate Acne

Study Arms (1)

Treatment Group

Device: Photopneumatic therapy

Interventions

Photopneumatic therapyDevice

Use of intense pulsed light (photo) in combination with vacuum technology (pneumatic) to treat mild to moderate acne.

Treatment Group

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

Sampling MethodNon-Probability Sample

Study Population

All genders and ethnic backgrounds. No subjects from vulnerable categories (i.e. minors, pregnant women, etc).

You may qualify if:

Fitzpatrick skin type I-VI.

Sponsors & Collaborators

Solta Medical
Industrylead

Study Sites (1)

Solta Medical

Hayward, California, 94545, United States

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 8, 2010

First Posted

December 9, 2010

Study Start

December 2010

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

September 2011

Actual (reported)

Male or female.

Subjects must be between 18 and 55 years of age.

Subjects must have mild to moderate acne (defined as 15 or more inflammatory or non-inflammatory lesions).

Subjects must read, understand, and sign the informed consent form.

Subjects must be willing and able to comply with all follow-up requirements.

You may not qualify if:

Subjects must not have active localized or systemic infections.
Subjects must not have a compromised ability for wound healing, such as: malnutrition, steroid use, history of collagen vascular disease (e.g. lupus, scleroderma, history of keloid scar formation), atrophic dermatitis or immunologic abnormalities such as vitiligo.
Subjects must not have received microdermabrasion within one (1) month prior to enrollment.
Subjects must not have received immunosuppressive medication(s) one (1) month prior to enrollment.
Subjects must not have received laser or light treatment within the last three (3) months.
Subjects must not have received dermabrasion, TCA peel greater than 20%, botulinum toxin type A, dermal fillers, photodynamic therapy (PDT), or cosmetic surgery within the last six (6) months .
Subjects must not be currently taking or have used isotretinoin (e.g. Accutane) within six (6) months prior to enrollment.
Subjects must agree to refrain from using cosmeceutical agents or topical agents during the course of the study, except as directed by study investigators.
Subjects must not have had previous ablative laser treatment.
Subjects must refrain from excessive sun exposure during participation in this study.
Subjects must not have any condition that results in photosensitivity or be taking any medication containing aminolevulinic acid (E.g. Levulan).
Subjects must not be a current or past smoker of cigarettes and/or cigars.
Subjects must not be pregnant.
Any condition or situation that would prevent the subject from safely completing all protocol requirements for participation.

Contact the study team to confirm eligibility.

Study Completion

September 2011

Actual (reported)

Last Updated

March 26, 2012

Record last verified: 2012-03

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01257555
Data provider: ClinicalTrials.gov
Source updated: 2012-03-26
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:21:06 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Study Arms (1)

Treatment Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations