WrinklesNCT01267149
A Clinical Study Evaluaing the Efficacy, Safety, and Patient Satisfaction of Injectable Hylaronic Acid With 0.3% Lidocain Hydrochloride, Prevelle Silk, for Superficial, Vertical Perioral Lines and Superficial, Horizontal, Lateral Canthal Lines
An observational study of Wrinkles, run by Goldman, Butterwick, Fitzpatrick and Groff at 2 sites in United States.
Trial summary
Statistical Hypotheses The Null Hypothesis: There is no difference in the reduction of lines in the treated areas as compared to baseline. Alternative Hypothesis: There is a difference in the reduction of lines in the treated areas as compared to baseline. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Wrinkles
- How many people
- 13 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2010to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cosmetic Dermatology Practice Patients
Who may be able to join
- Females and males in good general health between 35 to 65 years of age.
- Must be willing to give and sign a HIPPA form, informed consent form and a photographic release form
- Patient is planning to undergo Prevelle Silk treatment
- A potential subject's must exhibit:
- moderate to severe superficial, vertical perioral and horizontal canthus lines
- For FEMALE PATIENT OF CHILDBEARING POTENTIAL, must have had a regular menstrual cycle prior to study entry (a female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation) and is willing to use an acceptable form of birth control during the entire course of the study [i.e., acceptable methods of birth control are oral contraceptives, contraceptive patches/rings/implants Norplanit®, Depo-Provena®, double-barrier methods (e.g. condoms and spermicide), abstinence and vasectomies of partner with a documented second acceptable method of birth control should the patient become sexually active]. All systemic birth control measures must be in consistent use at least 30 days prior to study participation
- Negative urine pregnancy test results at the time of study entry (if applicable)
- Must be willing to comply with study regimen and complete the entire course of the study.
Who cannot join
- A patient with any UNCONTROLLED systemic disease. A potential patient in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study
- A patient with a significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study.
- A patient with a known hypersensitivity to any of the components of the study medications
- A patient who is actively smoking or plans to smoke at any time of the duration of this study
- A patient with an active skin condition/disease that might interfere with the diagnosis or evaluation of study parameters (i.e., atopic dermatitis, eczema, psoriasis, seborrheic dermatitis, herpes labialis)
- A patient planning any other cosmetic procedure to their facial area during the study period, other than the treatments that will be performed by the investigator
Show all 17Show fewer
- A patient using any topical (prescription or over the counter) medicated creams, lotions, gels, balms, powders, etc. on the treatment areas during the study period
- A patient receiving any topical products containing alpha-hydroxy acids, salicylic acid, and vitamins C or D (includes derivatives thereof) on the perioral or lateral canthal areas within 7 days prior to or during the study period, other than the study products
- A patient receiving any investigational drug and/or has had a microdermabrasion (light or medium skin peel) treatment on their perioral or lateral canthal areas within 30 days prior to or during the study period
- A patient using any topical tretinoin product or derivative on their perioral or lateral canthal areas within 12 weeks prior to or during the study period
- A patient receiving a chemical peel, any systemic steroids, a non-ablative laser, light or radio frequency treatment and/or has had a Dermabrasion (deep skin peel) or ablative laser treatments on their perioral or lateral canthal areas must have discontinued the drug/treatment and/or had the procedure at least 6 months prior to entering the study
- A patient that has previously been treated with botulinum toxin in the perioral or lateral canthal areas within the past six months
- A patient that has previously been treated with dermal filler in the perioral or lateral canthal areas within the past year
- A patient that with a history of allergic reaction to a dermal filler or lidocaine
- A patient that with a history of a permanent filler to the perioral or lateral canthal areas
- A female patient who is pregnant, nursing an infant or planning a pregnancy during the study [throughout the course of the study, women of child-bearing potential must use reliable forms of contraception (i.e., oral contraceptive, intrauterine device, abstinence, or spermicides and condoms used in combination)]
- Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Goldman, Butterwick, Fitzpatrick and Groff
La Jolla, California, 92121
Karina Brazdys, RN, 858-657-1002 ext. 109, kbrazdys@gbkderm.com
Donna Perez, 858-657-1002 ext. 120, dperez@gbkderm.com
- Recruiting
The Maas Clinic
San Francisco, California, 94115
Emily Shamban, 415-567-7000, research@maasclinic.com
Corey Mass, MD
About this study
Official title: Phase 4 Study - A Clinical Study Evaluaing the Efficacy, Safety, and Patient Satisfaction of Injectable Hylaronic Acid With 0.3% Lidocain Hydrochloride, Prevelle Silk, for Superficial, Vertical Perioral Lines and Superficial, Horizontal, Lateral Canthal Lines
Statistical Hypotheses The Null Hypothesis: There is no difference in the reduction of lines in the treated areas as compared to baseline.
Alternative Hypothesis: There is a difference in the reduction of lines in the treated areas as compared to baseline.
- Conditions
- Wrinkles
- Keywords
- superficial vertical perioral lines, superficial horizontal and lateral canthal lines, correct moderate to severe facial wrinkles and folds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2010 (estimated)
- Study startAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WrinklesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and Groff
- Sponsor type
- University, hospital or other
- Collaborators
- Mentor Worldwide, LLC
- Investigators
- Mitchell P Goldman, MD, Principal investigator, Dermatology and Cosmetic Laser Associated La Jolla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01267149
- Sponsor's protocol ID
- PRV-2010
- Status last verified
- Dec 2010
- First submitted
- 23 Dec 2010
- Last updated
- 28 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study - A Clinical Study Evaluaing the Efficacy, Safety, and Patient Satisfaction of Injectable Hylaronic Acid With 0.3% Lidocain Hydrochloride, Prevelle Silk, for Superficial, Vertical Perioral Lines and Superficial, Horizontal, Lateral Canthal Lines
- ClinicalTrials.gov ID
- NCT01267149
- Acronym / sponsor ID
- PRV-2010
- Conditions
- Wrinkles
- Keywords
- superficial vertical perioral lines, superficial horizontal and lateral canthal lines, correct moderate to severe facial wrinkles and folds
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and GroffUniversity, hospital or other
- Collaborators
- Mentor Worldwide, LLC
- Study start
- Aug 2010
- First posted
- 28 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Statistical Hypotheses The Null Hypothesis: There is no difference in the reduction of lines in the treated areas as compared to baseline.
Alternative Hypothesis: There is a difference in the reduction of lines in the treated areas as compared to baseline.
Study design
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cosmetic Dermatology Practice Patients
Key inclusion criteria (8 listed)
- Females and males in good general health between 35 to 65 years of age.
- Must be willing to give and sign a HIPPA form, informed consent form and a photographic release form
- Patient is planning to undergo Prevelle Silk treatment
- A potential subject's must exhibit:
- moderate to severe superficial, vertical perioral and horizontal canthus lines
Key exclusion criteria (17 listed)
- A patient with any UNCONTROLLED systemic disease. A potential patient in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study
- A patient with a significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study.
- A patient with a known hypersensitivity to any of the components of the study medications
- A patient who is actively smoking or plans to smoke at any time of the duration of this study
- A patient with an active skin condition/disease that might interfere with the diagnosis or evaluation of study parameters (i.e., atopic dermatitis, eczema, psoriasis, seborrheic dermatitis, herpes labialis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitchell P Goldman, MD principal investigator
Dermatology and Cosmetic Laser Associated La Jolla
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wrinkles, run by Goldman, Butterwick, Fitzpatrick and Groff at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karina Brazdys, RN (858-657-1002 ext. 109, kbrazdys@gbk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2010.