NCT02647528
Withdrawn
Phase 4
A Randomized, Blinded, Single-Centered, Placebo-Controlled Trial of Pulse Dyed Laser (Chromogenex Regenlite Transform) in the Treatment of Inflammatory Acne Vulgaris
Sadick Research Group1 site in 1 countryStarted: March 2016Last updated:
ConditionsAcne Vulgaris
Overview
- Phase
- Phase 4
- Status
- Withdrawn
- Sponsor
- Sadick Research Group
- Locations
- 1
- Primary Endpoint
- Global Acne Assessment Scoring
Overview
Brief Summary
A Randomized, Blinded, Single-Centered, Placebo-Controlled Trial of Pulse Dyed Laser (Chromogenex Regenlite Transform) in the Treatment of Inflammatory Acne Vulgaris
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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);
Outcomes
Primary Outcomes
Global Acne Assessment Scoring
Time Frame: Through study completion, an average of 6 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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