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Trial record 2 of 340 for:    acne AND facial

Six Months Evaluation of Next Science Acne Creams on Facial Acne in Adult Females.

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ClinicalTrials.gov Identifier: NCT03106766
Recruitment Status : Terminated (Decision from the Sponsor)
First Posted : April 10, 2017
Last Update Posted : August 30, 2017
Sponsor:
Collaborator:
Skin Laser & Surgery Specialists
Information provided by (Responsible Party):
Next Science TM

Brief Summary:
To assess facial acne vulgaris clinical and psychological outcomes by measuring differences in lesions counts, investigator global assessment, and subjects quality of life scores over 6 months in adult females treated with Next Science™ acne cream 2x or Next Science™ acne cream 1x in a double blind manner.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Acne cream 2X Drug: Acne cream 1X Early Phase 1

Detailed Description:
This is a 6-month, single-site, double-blind, controlled study in 20 female subjects with mild to moderate facial acne. Subjects will be randomized 1:1 to apply either topical Next Science™ acne cream 2x or Next Science™ acne cream 1x daily. Subjects will be evaluated for clinical acne and quality of life outcomes at baseline, 6, 12, 18 and 24 weeks.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Single-center, Double-blind, Controlled Study to Evaluate the Effect of Next Science™ Acne Cream on Mild to Moderate Facial Acne in Adult Females Over 6 Months.
Actual Study Start Date : March 27, 2017
Actual Primary Completion Date : August 14, 2017
Actual Study Completion Date : August 14, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: Acne cream 1x
Twice-daily facial applications of the 1X product (avoiding contact with eyes and all mucous membranes) to the entire face for 6 months.
Drug: Acne cream 1X
Twice daily application of facial acne cream 1X after facial cleansing

Experimental: Acne cream 2x
Twice-daily facial applications of the 2X product (avoiding contact with eyes and all mucous membranes) to the entire face for 6 months.
Drug: Acne cream 2X
Twice daily application of facial acne cream 2X after facial cleansing




Primary Outcome Measures :
  1. Reduction in Lesion Count [ Time Frame: Baseline versus 6 months ]
    Inflammatory acne lesions with both study acne cream products after 6 months of treatment compared to baseline. This will be measured as the mean percent change from baseline to week 24 in the inflammatory lesion count.


Secondary Outcome Measures :
  1. Inflammatory Lesion count over time [ Time Frame: weeks 6, 12, 18, and 24 ]
    to assess the mean percent change from baseline to weeks 6, 12, 18, and 24 inflammatory lesion counts

  2. Non-inflammatory acne lesion over time [ Time Frame: weeks 6, 12, 18, and 24 ]
    to assess the mean percent change from baseline to weeks 6, 12, 18, and 24 in non-inflammatory lesion counts

  3. Investigator Global Assessment over time [ Time Frame: weeks 6, 12, 18, and 24 ]
    to assess the mean percent change from baseline to weeks 6, 12, 18, and 24 in IGA

  4. Treatment Areas over time [ Time Frame: weeks 6, 12, 18, and 24 ]
    to assess the mean percent change from baseline to weeks 6, 12, 18, and 24 in treatment areas (erythema, dryness, stinging or burning, erosion, edema, pain and itching)

  5. Quality of Life over time [ Time Frame: weeks 6, 12, 18, and 24 ]
    The Acne-QoL questionnaire containing 19 questions organized into four domains which address the impact of facial acne on health-related quality of life will be administered. These are Self Perception, Role-social, Role-emotional and Acne Symptoms. Results will assess the mean percent change from baseline to weeks 6, 12, 18, and 24 in QoL.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Female ages 18 and above
  2. Has 20 or more inflammatory lesions on the face (papules and pustules) as determined by qualified examiner at Start of Treatment.
  3. In the area to be treated, has no significant facial dermatological conditions other than acne (as determined by the investigator) that would interfere with any study treatment or procedure
  4. Is willing and able to discontinue use of all baseline acne treatments for the duration of their trial participation
  5. Agrees to refrain from professional facial treatments during their trial participation.
  6. Agrees to avoid tanning booth use and minimize sun exposure during their trial participation.
  7. Is willing and able to follow instructions and procedures including attending scheduled study visits, which will require adequate transportation to the study site
  8. Is able to read, understand and sign the informed consent document and communicate with study staff and investigator.

Exclusion Criteria:

  1. Has more than 2 nodules/cystic acne lesions on the face
  2. Has a history of significant reactions to topical acne treatments, or a known allergy or hypersensitivity to any listed ingredients
  3. Has any history of skin malignancy
  4. Has used any systemic medications (including antibiotics, estrogens, retinoids) primarily for treatment of acne in the 21 days prior to randomization.
  5. Has used estrogens primarily as treatment for acne in the 21 days prior to randomization (estrogens prescribed for other reasons will be allowed if stable for at least 30 days prior to randomization).
  6. Has had any professional facial treatments in the 14 days prior to randomization.
  7. Has received any investigational treatment in the 30 days prior to randomization.
  8. Have any significant medical problems or other issues that would, in the investigator's judgment, affect their suitability for participation in this trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03106766


Locations
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United States, New Jersey
Skin Laser & Surgery Specialists of NY & NJ
Hackensack, New Jersey, United States, 07601
Sponsors and Collaborators
Next Science TM
Skin Laser & Surgery Specialists
Investigators
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Study Director: Matt Myntti, PhD Next Science

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Responsible Party: Next Science TM
ClinicalTrials.gov Identifier: NCT03106766     History of Changes
Other Study ID Numbers: CSP-004
First Posted: April 10, 2017    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases