A Five Day Clinical Study to Examine the Effects of a Benzoyl Peroxide Treatment on Facial Acne Lesions

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT02052752
First received: January 30, 2014
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

5 Day study to assess how quickly a topical acne product begins to work.


Condition Intervention Phase
Acne Vulgaris
Drug: 3% Benzoyl Peroxide
Drug: Neutrogena Rapid Clear
Drug: 3% Benzoyl Peroxide Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blinded Study to Evaluate the Ability of an Acne Treatment Product to Produce Visible Improvements in Acne Lesions Over a 5 Day Period of Once-daily Use

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • To assess the change in acne lesion swelling (height) for the 3% benzoyl peroxide gel test article relative to the vehicle gel after 4 once-daily applications. [ Time Frame: Change from baseline to Day 5 ] [ Designated as safety issue: No ]
    Change in acne lesion swelling


Secondary Outcome Measures:
  • To assess the change in acne lesion swelling (height) for the 3% benzoyl peroxide gel test article relative to the vehicle gel at other evaluations [ Time Frame: Change from baseline to 2hrs, 4hrs, Day 1 and Day 2 ] [ Designated as safety issue: No ]
    Change in acne lesion swelling


Estimated Enrollment: 90
Study Start Date: February 2014
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 3% Benzoyl Peroxide Gel
Product would be applied in the clinic on Days 0, 1, 2 and 3. Similar amounts of the product would be applied to the subject's face once daily at approximately the same time each day for 4 days.
Drug: 3% Benzoyl Peroxide
3% Benzoyl Peroxide Gel
Active Comparator: Neutrogena Rapid Clear
Product would be applied in the clinic on Days 0, 1, 2 and 3. Similar amounts of the product would be applied to the subject's face once daily at approximately the same time each day for 4 days.
Drug: Neutrogena Rapid Clear
Neutrogena Rapid Clear
Placebo Comparator: 3% Benzoyl Peroxide Placebo Gel
Product would be applied in the clinic on Days 0, 1, 2 and 3. Similar amounts of the product would be applied to the subject's face once daily at approximately the same time each day for 4 days.
Drug: 3% Benzoyl Peroxide Placebo
3% Benzoyl Peroxide Placebo Gel

  Eligibility

Ages Eligible for Study:   12 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol specific procedures are performed.
  2. Fitzpatrick Skin Type I - V.
  3. Male or female aged from 12 to 45 years, inclusive, at time of consent.
  4. Mild to moderate facial acne vulgaris as determined by the Investigator, with a minimum of 10 inflammatory lesions (papules plus pustules, including nasal lesions) and a minimum of 10 non-inflammatory lesions (open and closed comedones, including nasal lesions).
  5. Three appropriate and evaluable target lesions, as judged by the Investigator.
  6. Able to complete the study and to comply with study instructions.
  7. Sexually active females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant; including perimenopausal women who are less than 2 years from their last menses. Acceptable contraceptive methods include the following:

    • Hormonal contraception, including oral, injectable, or implantable methods started at least 2 months prior to screening. If hormonal contraception was started less than 2 months prior to screening, then a form of nonhormonal contraception should be added until the third continuous month of hormonal contraception has been completed.

"• Two forms of reliable nonhormonal contraception, to include the use of either an intrauterine device plus a reliable barrier method or 2 reliable barrier methods. Reliable barrier methods include condoms or diaphragms. A cervical cap is also a reliable barrier method, provided that the female subject has never given birth naturally. The combined use of a condom and spermicide constitute 2 forms of acceptable nonhormonal contraception, provided that they are both used properly. The use of spermicide alone and the improper use of condoms are inferior methods of contraception. Subjects with surgical sterilization, including tubal sterilization or partner's vasectomy, must use a form of nonhormonal contraception. A barrier method or sterilization plus spermicide is acceptable.

• Women who are not currently sexually active must agree to use a medically accepted method of contraception should they become sexually active while participating in the study.

Exclusion Criteria:

  1. Has any nodulocystic lesions at the baseline evaluation.
  2. Female who is pregnant, trying to become pregnant, or breastfeeding.
  3. Has active or chronic skin allergies.
  4. Has a history of acute or chronic disease that might interfere with or increase the risk of study participation.
  5. Had skin cancer treatment in preceding 12 months.
  6. Has damaged skin on facial areas (e.g., sunburn, tattoo, or scar).
  7. Had any medical procedure (e.g., laser resurfacing, chemical peel, or plastic surgery) on facial areas in preceding 12 months.
  8. Had any cosmetic procedure (e.g., microdermabrasion) on facial areas within 8 weeks of the baseline visit.
  9. Has any dermatological disorder that in the opinion of the Investigator may interfere with the accurate evaluation of the subject's facial appearance.
  10. Received any investigational drug or procedure within 28 days of study day 1 or is scheduled to receive an investigational drug (other than the study products) or procedure during the study.
  11. Currently using any medication that in the opinion of the Investigator may affect the evaluation of the study products or place the subject at undue risk.
  12. Has a history of known or suspected intolerance to any of the ingredients of the study products (i.e., benzoyl peroxide).
  13. Considered unable or unlikely to attend the necessary visits.
  14. Has used non-steroidal anti-inflammatory drugs for the treatment of acne or for treatment durations longer than 7 days for any condition.
  15. Uses oil-based sunscreens or sunscreens containing active ingredients that may have an effect on acne.
  16. Has received treatment with estrogens (including oral, implanted, and topical contraceptives), androgens, or anti-androgenic agents for 12 weeks or less immediately prior to starting application of the study product. Subjects who have been treated with estrogens, as described above, androgens, or anti-androgenic agents for more than 12 consecutive weeks prior to starting application of the study product are allowed to enroll as long as they do not expect to change dose, drug, or discontinue use during the study.
  17. Has used topical antibiotics on the face or use of systemic antibiotics within the previous 2 weeks.
  18. Has used topical anti-acne medications (e.g., BPO, azelaic acid, resorcinol, salicylates) within the previous 2 weeks.
  19. Has used topical corticosteroids on the face or systemic cortico- steroids within the previous 4 weeks. Use of inhaled, intra-articular or intra-lesional steroids other than for facial acne is acceptable.
  20. Has used systemic retinoids within the previous 6 months or topical retinoids within the previous 6 weeks.
  21. Uses abradants, facials, peels containing glycolic or other acids; masks, washes or soaps containing BPO, salicylic acid, or sulfacetamide sodium; non-mild facial cleansers, or moisturizers that contain retinol, salicylic acid or α- or β-hydroxy acids.
  22. Uses medications known to exacerbate acne (e.g., mega-doses of vitamin D [>2000 IU/day] and vitamin B12 [>1 mg/day]; systemic steroids; androgens; haloperidol; halogens such as iodide and bromide; lithium; hydantoin; and phenobarbital).
  23. Has had any facial procedure (e.g., blue light, chemical or laser peel, microdermabrasion) performed by any practitioner within 4 weeks before the study started or during the course of the study.

    -

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02052752

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Locations
United States, North Carolina
Dermatology Consulting Services - NC Recruiting
High Point, North Carolina, United States, 27262
Contact: US GSK Clinical Trials Call Center    877-379-3718    info@GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    info@GSKClinicalSupportHD@gsk.com   
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02052752     History of Changes
Other Study ID Numbers: RH02060
Study First Received: January 30, 2014
Last Updated: April 10, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Benzoyl Peroxide
Salicylic Acid
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents

ClinicalTrials.gov processed this record on July 23, 2014