A Study to Evaluate the Tolerance of an Acne Treatment in Sensitive Skin Subjects With Mild to Moderate Acne Vulgaris

NCT03128723 | Completed Results FDA Device

• 1 other identifier: CO-170125113728-SACT
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The study will look to evaluate the tolerance of a light therapy-based acne mask device in participants who report having sensitive skin. All participants will receive a cleanser, a light therapy mask, and an extra activator for the light therapy mask.

Conditions

Acne Vulgaris

Keywords

Acne

Outcome Measures

Primary Outcomes (6)

• Cutaneous Tolerance Scores: Erythema

  Cutaneous Tolerance Scores: Erythema (assessing skin redness), from Baseline to Day 28. Scale range is 0-3 where 0 = no redness, 1 = mild redness, 2 = moderate redness, and 3 = severe redness.

  Baseline to Day 28

• Cutaneous Tolerance Scores: Dryness/Scaling

  Cutaneous Tolerance Scores: Dryness/Scaling (assessing skin dryness), from Baseline to Day 28. Scale range is 0-3, where 0 = no dryness, 1 = mild dryness, 2 = moderate dryness, and 3 = severe dryness.

  Baseline to Day 28

• Cutaneous Tolerance Scores: Edema

  Cutaneous Tolerance Scores: Edema (assessing skin edema/swelling), from Baseline to Day 28. Scale range is 0-3 where 0 = no edema, 1 = mild edema, 2 = moderate edema, and 3 = severe edema.

  Baseline to Day 28

• Cutaneous Tolerance Scores: Burning/Stinging

  Cutaneous Tolerance Scores: Burning/Stinging (assessing skin burning/stinging), from Baseline to Day 28. Scale range is 0-3 where 0 = no burning/stinging, 1 = mild burning/stinging, 2 = moderate burning/stinging, and 3 = severe burning/stinging.

  Baseline to Day 28

• Cutaneous Tolerance Scores: Itching

  Cutaneous Tolerance Scores: Itching (assessing skin itching), from Baseline to Day 28. Scale range is 0-3 where 0 = no itching, 1 = mild itching, 2 = moderate itching, and 3 = severe itching.

  Baseline to Day 28

• Cutaneous Tolerance Scores: Tightness/Dry Feeling

  Cutaneous Tolerance Scores: Tightness/Dry Feeling (assessing skin tightness/dry feeling), from Baseline to Day 28. Scale range is 0-3 where 0 = no tightness/dry feeling, 1 = mild tightness/dry feeling, 2 = moderate tightness/dry feeling, and 3 = severe tightness/dry feeling.

  Baseline to Day 28

Secondary Outcomes (6)

• Cutaneous Tolerance Scores: Erythema

  Baseline to Day 14

• Cutaneous Tolerance Scores: Dryness/Scaling

  Baseline to Day 14

• Cutaneous Tolerance Scores: Edema

  Baseline to Day 14

• Cutaneous Tolerance Scores: Burning/Stinging

  Baseline to Day 14

• Cutaneous Tolerance Scores: Itching

  Baseline to Day 14

Study Arms (1)

Acne Mask

EXPERIMENTAL

The light therapy acne mask is applied to the face once in the evening for a duration of 10 minutes. The cleanser is used twice daily, once in the morning and once in the evening.

Device: Acne Mask

Interventions

Acne Mask DEVICE

The light therapy acne mask contains a combination of red and blue light-emitting diodes. The device is applied once daily, in the evening for a duration of 10 minutes.

Also known as: Light Therapy Acne Mask

Acne Mask

Eligibility Criteria

• Age: 12 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• In good general health
• Has mild to moderate facial acne
• Has sensitive skin per sensitive skin questionnaires
• Has score of "0" or "1" in all tolerance parameters (erythema, dryness/scaling, edema, burning/stinging, itching, and tightness/dryness feeling)
• Able to read, write, speak, and understand English
• Must agree to practice a medically acceptable form of birth control

You may not qualify if:

• Has known light or photo-sensitivity disorder
• Has very sensitive skin or known allergies to skincare products or the cleanser ingredients
• Has severe acne or pre-existing facial skin conditions other than mild to moderate acne
• Females that are pregnant, nursing, or planning to become pregnant
• Males with a female partner who is pregnant or planning to become pregnant
• Has been using a product or medication that the investigator determines will increase health risk to the subject or confuse the study results
• Is participating or has participated in another study with the past 30 days
• Has history of immunosuppression/immune deficiency disorders
• Has planned surgeries or invasive medical procedures scheduled during the study
• Is related to the Sponsor, Investigator, or Study Site

Sponsors & Collaborators

• Johnson & Johnson Consumer Inc. (J&JCI): lead

Study Sites (1)

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

Related Publications (3)

• Muizzuddin N, Marenus KD, Maes DH. Factors defining sensitive skin and its treatment. Am J Contact Dermat. 1998 Sep;9(3):170-5.

  PMID: 9744910 BACKGROUND

• Willis CM, Shaw S, De Lacharriere O, Baverel M, Reiche L, Jourdain R, Bastien P, Wilkinson JD. Sensitive skin: an epidemiological study. Br J Dermatol. 2001 Aug;145(2):258-63. doi: 10.1046/j.1365-2133.2001.04343.x.

  PMID: 11531788 BACKGROUND

• Sagransky M, Yentzer BA, Feldman SR. Benzoyl peroxide: a review of its current use in the treatment of acne vulgaris. Expert Opin Pharmacother. 2009 Oct;10(15):2555-62. doi: 10.1517/14656560903277228.

  PMID: 19761357 BACKGROUND

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Gboyega Adenaike
• Organization: JnJ Worldwide

aadenaike@its.jnj.com

908-874-1214

Study Officials

• Michael H Gold, M.D.

  Tennessee Clinical Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2017
• First Posted: April 25, 2017
• Study Start: April 30, 2017
• Primary Completion: June 8, 2017
• Study Completion: June 8, 2017
• Last Updated: August 31, 2018
• Results First Posted: August 31, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)