Epidermal Delivery of Ani-Aging Ingredients

NCT01847066 | Unknown

• 1 other identifier: ALMA 013-001
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Wrinkles; Acne Scars; Pigmentation

Keywords

wrinkles; acne scars; pigmentation

Outcome Measures

Primary Outcomes (1)

• 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: 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

  4 months

Study Arms (4)

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.

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

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.

Device: Erbium 2940 plus cosmetics plus Impact

Erbium 2940nm plus cosmetics

ACTIVE COMPARATOR

Patients shall be treated with Erbium 2940nm laser plus cosmetics only.

Device: Erbium 2940 plus cosmetics

Interventions

Erbium 2940 plus cosmetics plus Impact DEVICE

Laser used in all arms

Also known as: Laser

Erbium 2940 plus cosmetics plus Impact; Erbium plus cosmetics plus Impact

Erbium 2940 plus cosmetics DEVICE

laser

Also known as: Laser

Erbium 2940 plus cosmetics; Erbium 2940nm plus cosmetics

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Subjects meeting any of the following criteria will be excluded from participation:
• 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.
• 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

Sponsors & Collaborators

• Alma Lasers Inc.: lead

Study Sites (1)

NY Derm LLC

New York, New York, 10028, United States

Location

MeSH Terms

Interventions

Lasers

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2013
• First Posted: May 6, 2013
• Study Start: May 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: May 6, 2013

Record last verified: 2013-05

Locations

US (1)