A Study to Evaluate the Efficacy and Tolerance of 2 Acne Treatment Regimens on Subjects With Mild to Moderate Acne

Acne Vulgaris Clinical Trial

Official title:

A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne Treatment Regimens on Subjects With Mild to Moderate Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03124381
• Other study ID #: PS-170103145529-SACT
• Status: Completed
• Phase: N/A
• Start date: April 8, 2017
• Est. completion date: September 6, 2017

Study information

• Verified date: February 2019
• Source: Johnson & Johnson Consumer and Personal Products Worldwide
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will compare two different acne treatment regimens for the treatment of acne. Half of participants will receive a cleanser and a light therapy mask, while half of the participants will receive a cleanser, a light therapy topical gel-cream, and a light therapy mask.

Description:

Acne vulgaris is a common chronic skin disease involving blockage and/or inflammation of the hair follicles and their accompany sebaceous glands.

Research has shown the benefits of red and blue light therapy in the treatment of mild to moderate acne, with red and blue light shown to target acne-causing bacteria and have an effect on inflammation reduction.

Light-based therapies have been used successfully to treat dermatological conditions since the early 1900s, with various parts of the electromagnetic spectrum (i.e. ultraviolet [UV], visible, near-infrared, etc.) demonstrating different benefits. Light-emitting diodes (LEDs) offer delivery of light to the skin in a gentler manner as compared to light delivered by lasers, primarily due to the lower energy output. It has been reported that LEDs do not deliver enough power to damage tissues and do not have the same risk of accidental eye damage that lasers do. Visible-LED light therapy has been deemed a non-significant risk by the U.S. Food and Drug Administration (FDA) and has been approved for use in humans.

It is well established in the literature that visible light penetration into the epidermal and dermal layers of human skin is primarily governed by absorption and scattering events, with the latter being the more impactful of the two. Visible light penetration into human skin can be increased by reducing scattering. This can be accomplished by temporary hydrogen bonding disruption, which leads to the reversible rearrangement of epidermal and dermal structures that cause scattering. Glycerol (i.e. glycerin) is hypothesized to generate the level of hydrogen bonding disruption described above, and therefore will be investigated in the present study.

This study will look to evaluate and then compare the acne clearing efficacy and tolerance of two different acne treatment regimens - a cleanser used with a currently marketed red and blue light acne light therapy mask alone vs. the cleanser used with the same mask in conjunction with a light therapy topical gel-cream - to determine the efficacy of these treatments and then to assess if the efficacy of the light therapy mask used with the topical gel-cream treatment is non-inferior to the mask alone in the reduction of lesions in mild to moderate acne. If non-inferiority is demonstrated, the mask with topical gel-cream treatment will be further assessed for its superiority to the mask alone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: September 6, 2017
• Est. primary completion date: September 6, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 40 Years

Eligibility

Inclusion Criteria:

• Has mild to moderate facial acne

• Has 10-100 blackheads/whiteheads, 10-50 pimples, no cysts, and up to 2 large, hard, painful bumps (nodules)

• Able to read, write, speak, and understand English

• In general good health

• Must agree to practice a medically acceptable form of birth control.

• Intends to complete the study and willing to follow all study instructions.

Exclusion Criteria:

• Very sensitive skin or allergies/sensitivity to skincare products or the test product ingredients.

• Has a light or photosensitivity disorder or another medical condition that could increase risk to the subject or confuse the study results

• Is using medication that makes skin more sensitive to light

• Has severe acne or a pre-existing facial skin condition other than mild to moderate acne

• has an immune deficiency disorder

• has been using a product or medication that the stuff investigator determines will increase health risk to the subject or confuse the study results

• Females that are pregnant, nursing, or planning to become pregnant

• Males with a female partner who is pregnant or planning to become pregnant

• Has excessive facial hair

• Is participating in another study within past 4 weeks

• Is related to the Sponsor, Investigator, or Study Site

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Device:
• Cleanser, Acne Mask
A facial cleanser will be used twice daily (morning and evening). The light therapy mask will be used for 10 minutes in the evening after washing/drying the face.
• Cleanser, Gel-Cream, Acne Mask
A facial cleanser will be used twice daily (morning and evening). In the evening after cleansing, the gel-cream will be applied full face and allowed to dry before the light therapy mask is used for 10 minutes.

Locations

Country	Name	City	State
United States	Academic Dermatology Associates	Albuquerque	New Mexico
United States	Thomas J. Stephens and Associates, Inc.	Richardson	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Consumer Inc. (J&JCI)

Country where clinical trial is conducted

United States, 

References & Publications (12)

Ashkenazi H, Malik Z, Harth Y, Nitzan Y. Eradication of Propionibacterium acnes by its endogenic porphyrins after illumination with high intensity blue light. FEMS Immunol Med Microbiol. 2003 Jan 21;35(1):17-24. — View Citation

Barolet D. Light-emitting diodes (LEDs) in dermatology. Semin Cutan Med Surg. 2008 Dec;27(4):227-38. doi: 10.1016/j.sder.2008.08.003. Review. — View Citation

Bashkatov, AN, et al. Optical properties of human skin, subcutaneous and mucous tissues in the wavelength range from 400 to 2000 nm. J Phys D: Appl Phys, 38: 2543-2555, 2005.

Bashkatov, AN, et al. Optical properties of melanin in the skin and skin-like phantoms. Proc. of SPIE, 4162: 219-226, 2000.

Hirshburg J, Choi B, Nelson JS, Yeh AT. Correlation between collagen solubility and skin optical clearing using sugars. Lasers Surg Med. 2007 Feb;39(2):140-4. — View Citation

Jacques SL. Optical properties of biological tissues: a review. Phys Med Biol. 2013 Jun 7;58(11):R37-61. doi: 10.1088/0031-9155/58/11/R37. Epub 2013 May 10. Review. Erratum in: Phys Med Biol. 2013 Jul 21;58(14):5007-8. — View Citation

Kjeldstad B. Photoinactivation of Propionibacterium acnes by near-ultraviolet light. Z Naturforsch C. 1984 Mar-Apr;39(3-4):300-2. — View Citation

Lamouche G, Kennedy BF, Kennedy KM, Bisaillon CE, Curatolo A, Campbell G, Pazos V, Sampson DD. Review of tissue simulating phantoms with controllable optical, mechanical and structural properties for use in optical coherence tomography. Biomed Opt Express. 2012 Jun 1;3(6):1381-98. doi: 10.1364/BOE.3.001381. Epub 2012 May 15. — View Citation

Pogue BW, Patterson MS. Review of tissue simulating phantoms for optical spectroscopy, imaging and dosimetry. J Biomed Opt. 2006 Jul-Aug;11(4):041102. Review. — View Citation

Roelandts R. A new light on Niels Finsen, a century after his Nobel Prize. Photodermatol Photoimmunol Photomed. 2005 Jun;21(3):115-7. — View Citation

Salomatina E, Jiang B, Novak J, Yaroslavsky AN. Optical properties of normal and cancerous human skin in the visible and near-infrared spectral range. J Biomed Opt. 2006 Nov-Dec;11(6):064026. — View Citation

Wiegand, B, Luedtke, K, Rapp, SR. Acne Profile. Johnson & Johnson, One Johnson & Johnson Plaza, New Brunswick, NJ 08933-7003, assignee. Patent US 2006/0008484 A1. 12 Jan. 2006. Print.

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global Face Total Lesion Count - Percent Change - Baseline to Week 12	Percent change from baseline in global face total lesion count at Week 12	Baseline and Week 12
Secondary	Global Face Total Lesion Count - Percent Change - Baseline to Week 2	Percent change from baseline in global face total lesion count at Week 2	Baseline and Week 2
Secondary	Global Face Total Lesion Count - Percent Change - Baseline to Week 4	Percent change from baseline in global face total lesion count at Week 4	Baseline and Week 4
Secondary	Global Face Total Lesion Count - Percent Change - Baseline to Week 8	Percent change from baseline in global face total lesion count at Week 8	Baseline and Week 8
Secondary	Global Face Total Lesion Count - Percent Change From Baseline to the Mean of All Visits	Global face total lesion counts are averaged across all applicable post-baseline visits (Week 2, Week 4, Week 8, and Week 12). Percent change from baseline to the mean is then calculated.	Baseline to Week 2, Week 4, Week 8, and Week 12
Secondary	Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 2 and Week 4	Global face total lesion counts are averaged across Week 2 and Week 4. Percent change from baseline to the mean is then calculated.	Baseline to Week 2 and Week 4
Secondary	Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 4 and Week 8	Global face total lesion counts are averaged across Week 4 and Week 8. Percent change from baseline to the mean is then calculated.	Baseline to Week 4 and Week 8
Secondary	Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 8 and Week 12	Global face total lesion counts are averaged across Week 8 and Week 12. Percent change from baseline to the mean is then calculated.	Baseline to Week 8 and Week 12
Secondary	Global Face Open Comedones Count - Week 2	Open comedones count on global face - Week 2	2 weeks
Secondary	Global Face Open Comedones Count - Week 4	Open comedones count on global face - Week 4	4 weeks
Secondary	Global Face Open Comedones Count - Week 8	Open comedones count on global face - Week 8	8 weeks
Secondary	Global Face Open Comedones Count - Week 12	Open comedones count on global face - Week 12	12 weeks
Secondary	Global Face Closed Comedones Count - Week 2	Closed comedones count on global face - Week 2	2 weeks
Secondary	Global Face Closed Comedones Count - Week 4	Closed comedones count on global face - Week 4	4 weeks
Secondary	Global Face Closed Comedones Count - Week 8	Closed comedones count on global face - Week 8	8 weeks
Secondary	Global Face Closed Comedones Count - Week 12	Closed comedones count on global face - Week 12	12 weeks
Secondary	Global Face Inflammatory Lesion Count - Week 2	Papules and pustules counted together	2 weeks
Secondary	Global Face Inflammatory Lesion Count - Week 4	Papules and pustules counted together	4 weeks
Secondary	Global Face Inflammatory Lesion Count - Week 8	Papules and pustules counted together	8 weeks
Secondary	Global Face Inflammatory Lesion Count - Week 12	Papules and pustules counted together	12 weeks
Secondary	Global Face Non-Inflammatory Lesion Count - Week 2	Sum of open comedones and closed comedones	2 weeks
Secondary	Global Face Non-Inflammatory Lesion Count - Week 4	Sum of open comedones and closed comedones	4 weeks
Secondary	Global Face Non-Inflammatory Lesion Count - Week 8	Sum of open comedones and closed comedones	8 weeks
Secondary	Global Face Non-Inflammatory Lesion Count - Week 12	Sum of open comedones and closed comedones	12 weeks
Secondary	Global Face Total Lesion Count - Week 2	Sum of inflammatory and non-inflammatory lesions	2 weeks
Secondary	Global Face Total Lesion Count - Week 4	Sum of inflammatory and non-inflammatory lesions	4 weeks
Secondary	Global Face Total Lesion Count - Week 8	Sum of inflammatory and non-inflammatory lesions	8 weeks
Secondary	Global Face Total Lesion Count - Week 12	Sum of inflammatory and non-inflammatory lesions	12 weeks
Secondary	Investigator Global Acne Assessment - Week 1	Investigator Global Acne Assessment using Modified Cooke's Scale - Week 1. Modified Cooke's scale ranges from 0 = clear/no acne to 5 = very severe acne. Half-points are allowed.	1 week
Secondary	Investigator Global Acne Assessment - Week 2	Investigator Global Acne Assessment using Modified Cooke's Scale - Week 2. Modified Cooke's scale ranges from 0 = clear/no acne to 5 = very severe acne. Half-points are allowed.	2 weeks
Secondary	Investigator Global Acne Assessment - Week 4	Investigator Global Acne Assessment using Modified Cooke's Scale - Week 4. Modified Cooke's scale ranges from 0 = clear/no acne to 5 = very severe acne. Half-points are allowed.	4 weeks
Secondary	Investigator Global Acne Assessment - Week 8	Investigator Global Acne Assessment using Modified Cooke's Scale - Week 8. Modified Cooke's scale ranges from 0 = clear/no acne to 5 = very severe acne. Half-points are allowed.	8 weeks
Secondary	Investigator Global Acne Assessment - Week 12	Investigator Global Acne Assessment using Modified Cooke's Scale - Week 12. Modified Cooke's scale ranges from 0 = clear/no acne to 5 = very severe acne. Half-points are allowed.	12 weeks
Secondary	Overall Redness of Inflammatory Lesions - Week 1	Additional investigator efficacy assessment. 0-9 scale where 0 = no redness associated with the inflammatory lesions; 9 = overall, inflammatory lesions exhibit severe degree of redness	1 week
Secondary	Overall Redness of Inflammatory Lesions - Week 2	Additional investigator efficacy assessment. 0-9 scale where 0 = no redness associated with the inflammatory lesions; 9 = overall, inflammatory lesions exhibit severe degree of redness	2 weeks
Secondary	Overall Redness of Inflammatory Lesions - Week 4	Additional investigator efficacy assessment. 0-9 scale where 0 = no redness associated with the inflammatory lesions; 9 = overall, inflammatory lesions exhibit severe degree of redness	4 weeks
Secondary	Overall Redness of Inflammatory Lesions - Week 8	Additional investigator efficacy assessment. 0-9 scale where 0 = no redness associated with the inflammatory lesions; 9 = overall, inflammatory lesions exhibit severe degree of redness	8 weeks
Secondary	Overall Redness of Inflammatory Lesions - Week 12	Additional investigator efficacy assessment. 0-9 scale where 0 = no redness associated with the inflammatory lesions; 9 = overall, inflammatory lesions exhibit severe degree of redness	12 weeks
Secondary	Overall Size of Inflammatory Lesions - Week 1	Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large	1 week
Secondary	Overall Size of Inflammatory Lesions - Week 2	Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large	2 weeks
Secondary	Overall Size of Inflammatory Lesions - Week 4	Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large	4 weeks
Secondary	Overall Size of Inflammatory Lesions - Week 8	Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large.	8 weeks
Secondary	Overall Size of Inflammatory Lesions - Week 12	Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large	12 weeks