A Study to Evaluate the Effectiveness and Tolerance of Two Acne Treatments on Subjects With Mild to Moderate Acne.

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02698436

Acronym

TIGER

Enrollment

103

Registered

2016-03-03

Start date

2016-03-31

Completion date

2016-08-31

Last updated

2018-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne Vulgaris

Keywords

Acne

Brief summary

This study will compare two different acne treatments for the treatment of acne. Half of the participants will receive two marketed acne products (cleanser and leave-on topical treatment), while the other half of the participants will receive a marketed cleanser and a light-therapy device.

Detailed description

Acne is a common chronic skin disease involving blockage and/or inflammation of the hair follicles and their accompanying sebaceous gland. Benzoyl peroxide (BPO) is one of the most effective and well-studied over-the-counter (OTC) acne therapies, is generally regarded as safe and effective and is considered as a first-line treatment for acne. Topical BPO monotherapy products for at-home acne treatment have been available for OTC use for more than 30 years and studies have indicated that a low dose of BPO may be an effective approach for treating acne using an OTC product when applied consistently to larger areas of the face due primarily to its effects against acne-causing bacteria. BPO has anti-inflammatory and keratolytic properties, but is thought to act primarily to control P. acnes by releasing reactive oxygen species that are toxic to the bacteria. The most common side effect of topical BPO treatment is skin irritation, which can include erythema, burning, and peeling. As an alternative to topical OTC standard of care therapies, research has also 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 the acne-causing bacteria and have an effect on inflammation reduction. Light-based therapies have been successfully used to treat dermatological conditions since the early 1900's, with various parts of the electromagnetic spectrum (i.e. 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 Food and Drug Administration and has been approved for use in humans. This study will look to compare the acne clearing efficacy and tolerance of two different acne treatments: a currently marketed 2.5% BPO full-face topical OTC treatment, and an Investigational red and blue light acne light therapy mask, to determine if the acne resolution efficacy of the Investigational mask is as effective as a current OTC standard of care for at-home treatment of mild to moderate acne.

Interventions

DEVICEAcne Mask

The light therapy device 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

DRUG2.5% Benzoyl Peroxide Treatment

The BPO treatment is applied twice daily, once in the morning and once in the evening

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

12 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

* Has mild to moderate acne * Has 10 - 100 pimples, 10 - 50 inflamed red pimples, up to 2 raised bumps and no cysts * In general good health * Must avoid excessive sun exposure and any light treatments or any professional or aesthetic spa-like procedures * Must not be pregnant, nursing or intend to become pregnant during the study * Must agree to practice a medically acceptable form of birth control. * Must be able to read, speak, write and understand English

Exclusion criteria

* Allergies or sensitivities to product ingredients or to light * Has severe acne or pre-existing dermatological facial condition * Has an uncontrolled disease or immune deficient disorder * Is pregnant, breast-feeding or intending to become pregnant * Has been taking prescription drug medication for acne or antibiotics for the past 6 months

Design outcomes

Primary

Measure	Time frame
Percent Change of Global Face Total Acne Lesion Count From Baseline	Baseline to 12 Weeks

Secondary

Measure	Time frame	Description
Acne Lesion Counts Total Global Face - Week 4	4 Weeks	Acne Lesion Count Total Global Face Week 4
Acne Lesion Counts Total Global Face - Week 8	8 Weeks	Acne Lesion Count Total Global Face Week 8
Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 1	Baseline to 1 Week	—
Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 2	Baseline to 2 Weeks	—
Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 4	Baseline to 4 Weeks	—
Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 8	Baseline to 8 Weeks	—
Acne Lesion Counts Total Global Face - Baseline	Baseline	Acne Lesion Count Total Global Face at Baseline
Acne Lesion Counts Total Global Face - Week 2	2 Weeks	Acne Lesion Count Total Global Face Week 2
Acne Lesion Counts Total Global Face - Week 12	12 Weeks	Acne Lesion Count Total Global Face Week 12
Investigator Global Acne Assessment - Baseline	Baseline	Investigator's assessment of subject's acne condition using a score of 0 (best) and 5 (worst) on the Modified Cook's scale. 0 Clear Residual hyperpigmentation and erythema may be present. 1. Almost Clear. A few scattered comedones and a few (less than five) small papules. 2. Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules. 3. Moderate More than half of the face is involved. Numerous comedones, papules and pustules. 4. Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts. 5. Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present.
Investigator Global Acne Assessment - Week 1	1 Week	Investigator's assessment of subject's acne condition using a score of 0 (best) and 5 (worst) on the Modified Cook's scale. 0 Clear Residual hyperpigmentation and erythema may be present. 1. Almost Clear. A few scattered comedones and a few (less than five) small papules. 2. Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules. 3. Moderate More than half of the face is involved. Numerous comedones, papules and pustules. 4. Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts. 5. Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present.
Investigator Global Acne Assessment - Week 2	2 Weeks	Investigator's assessment of subject's acne condition using a score of 0 (best) and 5 (worst) on the Modified Cook's scale. 0 Clear Residual hyperpigmentation and erythema may be present. 1. Almost Clear. A few scattered comedones and a few (less than five) small papules. 2. Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules. 3. Moderate More than half of the face is involved. Numerous comedones, papules and pustules. 4. Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts. 5. Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present.
Investigator Global Acne Assessment - Week 4	4 Weeks	Investigator's assessment of subject's acne condition using a score of 0 (best) and 5 (worst) on the Modified Cook's scale. 0 Clear Residual hyperpigmentation and erythema may be present. 1. Almost Clear. A few scattered comedones and a few (less than five) small papules. 2. Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules. 3. Moderate More than half of the face is involved. Numerous comedones, papules and pustules. 4. Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts. 5. Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present.
Investigator Global Acne Assessment - Week 8	8 Weeks	Investigator's assessment of subject's acne condition using a score of 0 (best) and 5 (worst) on the Modified Cook's scale. 0 Clear Residual hyperpigmentation and erythema may be present. 1. Almost Clear. A few scattered comedones and a few (less than five) small papules. 2. Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules. 3. Moderate More than half of the face is involved. Numerous comedones, papules and pustules. 4. Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts. 5. Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present.
Investigator Global Acne Assessment - Week 12	12 Weeks	Investigator's assessment of subject's acne condition using a score of 0 (best) and 5 (worst) on the Modified Cook's scale. 0 Clear Residual hyperpigmentation and erythema may be present. 1. Almost Clear. A few scattered comedones and a few (less than five) small papules. 2. Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules. 3. Moderate More than half of the face is involved. Numerous comedones, papules and pustules. 4. Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts. 5. Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present.
Acne Lesion Counts Total Global Face - Week 1	1 Week	Acne Lesion Count Total Global Face Week 1

Countries

United States

Participant flow

Participants by arm

Arm	Count
Acne Mask Light therapy mask applied to the face once in the evening for a duration of 10 minutes	59
2.5% Benzoyl Peroxide Treatment Applied BPO treatment once daily	58
Total	117

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	1	0
Overall Study	Lost to Follow-up	2	4
Overall Study	Non-compliance with study regimen	1	0
Overall Study	Withdrawal by Subject	3	3

Baseline characteristics

Characteristic	Total	Acne Mask	2.5% Benzoyl Peroxide Treatment
Age, Continuous	18.2 years STANDARD_DEVIATION 5.87	17.8 years STANDARD_DEVIATION 5.79	18.7 years STANDARD_DEVIATION 5.97
Region of Enrollment USA	117 participants	59 participants	58 participants
Sex: Female, Male Female	62 Participants	31 Participants	31 Participants
Sex: Female, Male Male	55 Participants	28 Participants	27 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 59	0 / 58
other Total, other adverse events	0 / 59	0 / 58
serious Total, serious adverse events	0 / 59	0 / 58