WrinklesNCT01847066
Epidermal Delivery of Ani-Aging Ingredients
A study testing Erbium 2940 plus cosmetics plus Impact and Erbium 2940 plus cosmetics in people with Wrinkles and Acne Scars, run by Alma Lasers Inc. at 1 site in United States.
Trial summary
To assess the safety and efficacy of an ablative fractional, 2940-nm laser combined with the US Impact and cosmetic -formulations for improving the appearance of wrinkles, acne scars and pigmented skin. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Wrinkles, Acne Scars, Pigmentation
- What is being tested?
- Erbium 2940 plus cosmetics plus Impact and Erbium 2940 plus cosmetics
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Sep 2013
- Phase
- Interventional
- 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
Who may be able to join
- Male or female in good general health between 35 to 65 years of age.
- Must be willing to execute informed consent. Patient must also consent to having photos taken at each visit.
- A potential subject must exhibit:
- Facial wrinkling, acne scars or pigmentation.
- For FEMALE PATIENTS 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 subject become sexually active]. All systemic birth control measures must be in consistent use at least 30 days prior to study participation.
- Must be willing to comply with study visits and complete the entire course of the study.
Who cannot join
- Subjects meeting any of the following criteria will be excluded from participation:
- The following are exclusion criteria for subjects in this study:
- A subject that underwent a laser / light treatment on the face within 12 months, or any topical treatment on the face with 6 months.
- A subject with any UNCONTROLLED systemic disease. A potential subject in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study.
- A subject 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 subject using any topical product containing a retinoid, retinol, or other vitamin A derivative within 3 months prior to or during the study period.
Show all 17Show fewer
- A subject using any systemic steroid therapy within 6 months prior to or during the study period.
- A subject that has been treated with Botox/Dysport or filler/biostimulatory molecule injections to his/her face within the past six months.
- A subject using any topical medicated creams, lotions, powders, etc. on the treatment areas during the study period, other than the study treatment regimen within 14 days.
- A subject that has previously been treated with systemic retinoids within the past year (e.g., Accutane®, Roche Dermatologics).
- A subject with recently excessive facial exposure to sunlight or artificial UV light (e.g.: use of tanning beds/booths and/or sunbathing). During the study, when excessive sun exposure is unavoidable, subjects must wear appropriate protective clothing (e.g. hat) and comply with the study dosing regimen of daily application of the dispersed sunblock.
- A subject with a recent history or active presence of any facial skin condition/disease that might interfere with the diagnosis or evaluation of study parameters (i.e. moderate to severe acne vulgaris, atopic dermatitis, psoriasis, rosacea, seborrheic dermatitis, excessive facial hair or coloration).
- A female subject 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.
- Subjects who are pregnant, breast-feeding, or planning a pregnancy. Females of childbearing potential, must be either:
- using the same form (i.e. brand) and dosage regimen of an oral contraceptive pill or of a hormonal implant continuously for three months prior to study entry and continue during the entire study, or
- willing to use a different form of birth control during the study other than any form of hormonal methods such as oral contraceptive pills and hormonal implants 30 day prior to study entry and during the entire study period. For the purpose of this study, the following are considered acceptable methods of birth control: double-barrier methods (e.g.: condoms and spermicide), abstinence and vasectomies of partner with a documented second acceptable method of birth control should the subject become sexually active.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fractional Erbium 2940nm Laser & Impact US for Trans-Epidermal Delivery of Cosmetic Anti-Aging Ingredients for Wrinkles, Acne Scars and Pigmented Skin: A Randomized Split Face & Dorsal Hand Side by Side Study
To assess the safety and efficacy of an ablative fractional, 2940-nm laser combined with the US Impact and cosmetic -formulations for improving the appearance of wrinkles, acne scars and pigmented skin.
Read the detailed description
This is a randomized, split face \& dorsal hand side by side study. The purpose of the side by side study is to determine whether the use of the Impact with the ablative fractional 2940nm laser and cosmetics improves the cosmetic outcomes when compared to using just the ablative fractional 2940nm laser with the cosmetics.
This is a non-significant risk aesthetic clinical study. Only cosmetic formulations will be used during the study, These cosmetic formulations do not contain any ingredient categorized as a drug by the FDA.
- Conditions
- Wrinkles, Acne Scars, Pigmentation
- Being tested
- Erbium 2940 plus cosmetics plus Impact, Erbium 2940 plus cosmetics
- Keywords
- wrinkles, acne scars, pigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erbium 2940 plus cosmetics plus ImpactDevice
Also called Laser
Laser used in all arms
Erbium 2940 plus cosmeticsDevice
Also called Laser
laser
| Study group | Role | What they receive |
|---|---|---|
| Erbium plus cosmetics plus Impact | Active comparator | Erbium 2940 plus cosmetics plus Impact Patient shall be treated with erbium 2940nm laser, cosmetics and the Impact. Receives: Device: Erbium 2940 plus cosmetics plus Impact |
| Erbium 2940 plus cosmetics | Active comparator | Erbium 2940 plus cosmetics Patient shall be treated with erbium 2940nm laser, cosmetics Receives: Device: Erbium 2940 plus cosmetics |
| Erbium 2940 plus cosmetics plus Impact | Active comparator | Patient shall be treated with erbium 2940nm laser, cosmetics and the Impact. Receives: Device: Erbium 2940 plus cosmetics plus Impact |
| Erbium 2940nm plus cosmetics | Active comparator | Patients shall be treated with Erbium 2940nm laser plus cosmetics only. Receives: Device: Erbium 2940 plus cosmetics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Photographs to determine improvement of appearance
An independent panel of qualified blinded physicians (masked) with respect to subject-identity, photo chronology, treatment methodology (with/without Impact module), study time point, and treatment assignment will grade the photographs as determined by:
- Clinical Photographs Alexiades-Armenakas Grading Scale Assessment
- Clinical Photographs Acne Scar Grading Scale (see section 7.1)
- Clinical Photographs Hand Pigmentation Grading Scale (see section 7.1)
- Spectrophotometric (Reflectance Spectroscopy) Analysis of La*b* values
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2013 (estimated)
- Study startMay 2013
- Primary completionSep 2013 (estimated)
- Study completionSep 2013 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alma Lasers Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01847066
- Sponsor's protocol ID
- ALMA 013-001
- Status last verified
- May 2013
- First submitted
- 2 May 2013
- Last updated
- 6 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fractional Erbium 2940nm Laser & Impact US for Trans-Epidermal Delivery of Cosmetic Anti-Aging Ingredients for Wrinkles, Acne Scars and Pigmented Skin: A Randomized Split Face & Dorsal Hand Side by Side Study
- ClinicalTrials.gov ID
- NCT01847066
- Acronym / sponsor ID
- ALMA 013-001
- Conditions
- Wrinkles, Acne Scars, Pigmentation
- Keywords
- wrinkles, acne scars, pigmentation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Alma Lasers Inc.Industry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 6 May 2013 (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.
To assess the safety and efficacy of an ablative fractional, 2940-nm laser combined with the US Impact and cosmetic -formulations for improving the appearance of wrinkles, acne scars and pigmented skin.
Detailed description
This is a randomized, split face \& dorsal hand side by side study. The purpose of the side by side study is to determine whether the use of the Impact with the ablative fractional 2940nm laser and cosmetics improves the cosmetic outcomes when compared to using just the ablative fractional 2940nm laser with the cosmetics.
This is a non-significant risk aesthetic clinical study. Only cosmetic formulations will be used during the study, These cosmetic formulations do not contain any ingredient categorized as a drug by the FDA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Erbium plus cosmetics plus Impact | Active comparator | Device: Erbium 2940 plus cosmetics plus ImpactErbium 2940 plus cosmetics plus Impact Patient shall be treated with erbium 2940nm laser, cosmetics and the Impact. |
| Erbium 2940 plus cosmetics | Active comparator | Device: Erbium 2940 plus cosmeticsErbium 2940 plus cosmetics Patient shall be treated with erbium 2940nm laser, cosmetics |
| Erbium 2940 plus cosmetics plus Impact | Active comparator | Device: Erbium 2940 plus cosmetics plus ImpactPatient shall be treated with erbium 2940nm laser, cosmetics and the Impact. |
| Erbium 2940nm plus cosmetics | Active comparator | Device: Erbium 2940 plus cosmeticsPatients shall be treated with Erbium 2940nm laser plus cosmetics only. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female in good general health between 35 to 65 years of age.
- Must be willing to execute informed consent. Patient must also consent to having photos taken at each visit.
- A potential subject must exhibit:
- Facial wrinkling, acne scars or pigmentation.
- For FEMALE PATIENTS 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 subject become sexually active]. All systemic birth control measures must be in consistent use at least 30 days prior to study participation.
Key exclusion criteria (17 listed)
- A subject that underwent a laser / light treatment on the face within 12 months, or any topical treatment on the face with 6 months.
- A subject with any UNCONTROLLED systemic disease. A potential subject in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study.
- A subject 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 subject using any topical product containing a retinoid, retinol, or other vitamin A derivative within 3 months prior to or during the study period.
- A subject using any systemic steroid therapy within 6 months prior to or during the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erbium 2940 plus cosmetics plus ImpactAlso: LaserLaser used in all arms | Device | Erbium 2940 plus cosmetics plus Impact, Erbium plus cosmetics plus Impact |
| Erbium 2940 plus cosmeticsAlso: Laserlaser | Device | Erbium 2940 plus cosmetics, Erbium 2940nm plus cosmetics |
Primary outcome
Clinical Photographs to determine improvement of appearance
Time frame: 4 months
An independent panel of qualified blinded physicians (masked) with respect to subject-identity, photo chronology, treatment methodology (with/without Impact module), study time point, and treatment assignment will grade the photographs as determined by: 1. Clinical Photographs Alexiades-Armenakas Grading Scale Assessment 2. Clinical Photographs Acne Scar Grading Scale (see section 7.1) 3. Clinical Photographs Hand Pigmentation Grading Scale (see section 7.1) 4. Spectrophotometric (Reflectance Spectroscopy) Analysis of La*b* values
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erbium 2940 plus cosmetics plus Impact and Erbium 2940 plus cosmetics in people with Wrinkles and Acne Scars, run by Alma Lasers Inc. at 1 site 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 6 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 6 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Photographs to determine improvement of appearance (time frame: 4 months). It is what the study was designed to measure, not a finding.
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 6 May 2013.