Macrolane for Enhancement of the Shape and Fullness of the Female Breast

NCT ID: NCT01308853

Last Updated: 2022-09-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2010-05-31

Brief Summary

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The study evaluates treatment procedure, efficacy and safety of Macrolane for female breast enhancement.

Detailed Description

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This study evaluates the injection technique and treatment outcome by stepwise inclusion and treatment of Macrolane for female breast enhancement.

Conditions

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Breast Enhancement

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Macrolane

Open label

Group Type OTHER

Macrolane

Intervention Type DEVICE

Device: Macrolane Treatment: Initial injection (incl touch-up) of a maximum of 120 ml/breast.

Interventions

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Macrolane

Device: Macrolane Treatment: Initial injection (incl touch-up) of a maximum of 120 ml/breast.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Female between 25 and 50 years of age with small breasts seeking enhancement of the shape and fullness of the breast

Exclusion Criteria

* Unreasonable expectations
* Any medical condition that may interfere with the treatment
Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Galderma R&D

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Per Heden, M.D.

Role: PRINCIPAL_INVESTIGATOR

Akademikliniken, Stockholm, Sweden

References

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Heden P, Olenius M, Tengvar M. Macrolane for breast enhancement: 12-month follow-up. Plast Reconstr Surg. 2011 Feb;127(2):850-860. doi: 10.1097/PRS.0b013e318200ae57.

Reference Type RESULT
PMID: 20966812 (View on PubMed)

Other Identifiers

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31GB0607

Identifier Type: -

Identifier Source: org_study_id

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