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

NCT03106766 | Terminated Early Phase 1 FDA Drug

• 1 other identifier: CSP-004
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• Reduction in Lesion Count

  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.

  Baseline versus 6 months

Secondary Outcomes (5)

• Inflammatory Lesion count over time

  weeks 6, 12, 18, and 24

• Non-inflammatory acne lesion over time

  weeks 6, 12, 18, and 24

• Investigator Global Assessment over time

  weeks 6, 12, 18, and 24

• Treatment Areas over time

  weeks 6, 12, 18, and 24

• Quality of Life over time

  weeks 6, 12, 18, and 24

Study Arms (2)

Acne cream 1x

EXPERIMENTAL

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

Acne cream 2x

EXPERIMENTAL

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

Interventions

Acne cream 2X DRUG

Twice daily application of facial acne cream 2X after facial cleansing

Acne cream 2x

Acne cream 1X DRUG

Twice daily application of facial acne cream 1X after facial cleansing

Acne cream 1x

Eligibility Criteria

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

You may qualify if:

• Female ages 18 and above
• Has 20 or more inflammatory lesions on the face (papules and pustules) as determined by qualified examiner at Start of Treatment.
• 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
• Is willing and able to discontinue use of all baseline acne treatments for the duration of their trial participation
• Agrees to refrain from professional facial treatments during their trial participation.
• Agrees to avoid tanning booth use and minimize sun exposure during their trial participation.
• Is willing and able to follow instructions and procedures including attending scheduled study visits, which will require adequate transportation to the study site
• Is able to read, understand and sign the informed consent document and communicate with study staff and investigator.

You may not qualify if:

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

Sponsors & Collaborators

• Next Science TM: lead
• Skin Laser & Surgery Specialists: collaborator

Study Sites (1)

Skin Laser & Surgery Specialists of NY & NJ

Hackensack, New Jersey, 07601, United States

Location

Related Publications (1)

• Marshall-Hudson A, Tuley M, Damstra M, Dosik JS, Myntti MF, Porral D, Palomo J. A 6-month, Multi-center, Double-blind, Controlled Study to Evaluate the Effect of a Biofilm Disrupting Acne Cream on Mild-to-Moderate Facial Acne in Female Volunteer Subjects. J Clin Aesthet Dermatol. 2023 Apr;16(4):43-52.

  PMID: 37077927 DERIVED

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

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

Study Officials

• Matt Myntti, PhD

  Next Science

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: April 10, 2017
• Study Start: March 27, 2017
• Primary Completion: August 14, 2017
• Study Completion: August 14, 2017
• Last Updated: August 30, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)