A Trial of Pulse Dyed Laser (Chromogenex Regenlite Transform) in the Treatment of Inflammatory Acne Vulgaris

NCT02647528 | Withdrawn Phase 4 DMC

• 1 other identifier: Chromogenex Acne
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

A Randomized, Blinded, Single-Centered, Placebo-Controlled Trial of Pulse Dyed Laser (Chromogenex Regenlite Transform) in the Treatment of Inflammatory Acne Vulgaris

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• Global Acne Assessment Scoring

  Through study completion, an average of 6 months

Study Arms (2)

Treatment

EXPERIMENTAL

Patients in this arm receive treatment

Device: Chromogenix Regenlite Transform Treatment

Placebo

PLACEBO COMPARATOR

Patients in this arm do not receive treatment

Device: Chromogenix Regenlite Transform Placebo

Interventions

Chromogenix Regenlite Transform Treatment DEVICE

Pulse Dyed Laser - 7mm spot size 3-3.6 J/cm2

Treatment

Chromogenix Regenlite Transform Placebo DEVICE

Pulse Dyed Laser - 7mm spot size 0 J/cm2

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who are able to give voluntary, written informed consent to participate in this study and from whom consent has been obtained including HIPAA authorization.
• Healthy male or non-pregnant female 18-65 years-of-age with a clinical diagnosis of mild to moderate facial acne vulgaris.
• Subject must have at least eight and not more than fifty inflammatory facial lesions (i.e., papules/pustules) and no nodules on the face. For the purposes of study treatment and evaluation, these lesions should be limited to the facial treatment area including those present on the nose. Lesions involving the eyes, and scalp should be excluded from the count.
• Subject must be in general good health and free from any clinically significant disease, other than acne, that might interfere with the study evaluations.
• Female subjects of childbearing potential (excluding women who are surgically sterilized or postmenopausal for at least 1 year), in addition to having a negative urine pregnancy test, must be willing to use an acceptable form of birth control during the study from the day of the first dose administration to 30 days after the last administration of study drug.
• Subjects who use make-up must have used the same brands/types of make-up for a minimum period of 14 days prior to study entry and must agree to use the same make-up brand/type and frequency of use throughout the study.
• Subjects must agree not to have any other procedures affecting skin quality (microdermabrasion, peels, acne treatments, etc.) for the duration of the study.
• Subjects must understand the study and be able to follow study instructions as well as attend the required study visits.
• Subjects who agree to be photographed for research purposes and their identity may not be concealed in these photographs.

You may not qualify if:

• Subjects whom are pregnant, planning to become pregnant or breastfeeding. A urine pregnancy test will be done to rule out pregnancy.
• Subjects of child-bearing potential who are not using an approved method of birth control (oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide or abstinence). Females of non-childbearing potential are defined as post-menopausal (absence of menstrual bleeding for one year), hysterectomy or bilateral oophorectomy.
• Subjects who cannot understand or are not willing to comply with the requirements of the study.
• Presence of any skin condition on the face that would interfere with the diagnosis or assessment of acne.
• Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne.
• The use within 6 months prior to baseline of oral retinoids (e.g. Accutane®) or therapeutic vitamin A supplements of greater than 10,000units/day (multivitamins are allowed).
• The use of estrogens or oral contraceptives for less than 3 months prior to baseline.
• The use within 1 month prior to baseline of:
• topical retinoids to the face;
• systemic antibiotics known to have an impact on the severity of facial acne (e.g., containing tetracycline and its derivatives, erythromycin and its derivatives, sulfamethoxazole, or trimethoprim);
• systemic corticosteroids (Note: intranasal and inhalational corticosteroids do not require a washout and maybe used throughout the trial if the subject is on a stable dose).
• Use within 2 weeks prior to baseline of:
• topical corticosteroids;
• topical antibiotics;
• topical medications for acne (e.g., metronidazole).

Sponsors & Collaborators

• Sadick Research Group: lead

Study Sites (1)

Sadick Research Group

New York, New York, 10075, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2015
• First Posted: January 6, 2016
• Study Start: March 1, 2016
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: December 6, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)