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

NCT ID: NCT03106766

Last Updated: 2017-08-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-27
• Study Completion Date: 2017-08-14

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.

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.

Conditions

Acne Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Acne cream 1X

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Acne cream 2X

Intervention Type: DRUG

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

Interventions

Acne cream 2X

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

Intervention Type: DRUG

Acne cream 1X

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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Skin Laser & Surgery Specialists

OTHER

Sponsor Role: collaborator

Next Science TM

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matt Myntti, PhD

Role: STUDY_DIRECTOR

Next Science

Locations

Skin Laser & Surgery Specialists of NY & NJ

Hackensack, New Jersey, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37077927 (View on PubMed)

Other Identifiers

CSP-004

Identifier Type: -

Identifier Source: org_study_id