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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03128723

Enrollment

Registered

2017-04-25

Start date

2017-04-30

Completion date

2017-06-08

Last updated

2018-08-31

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

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.

Detailed description

Acne and sensitive skin can be closely connected due to the reported involvement of an impaired skin barrier in both conditions, which can be further aggravated by potentially irritating topical treatments. A patient's sensitive skin may be caused by the skincare products that they are using, the amount that they are applying (over-usage), or the concomitant effect of the different products being used, as well as by underlying medical conditions. While sensitive skin can be self-perceived and sometimes clinically apparent, as there is no agreed upon medical definition of 'sensitive skin', it is a 'diagnosis' primarily made by the patient's perception. The high incidence of this problem and potential for further irritation due to current topical treatments has left many patients in need of a sensitive skin solution for their acne. Current at-home topical treatments for mild to moderate acne include Over-the-Counter (OTC) options, primarily with either benzoyl peroxide, or salicylic acid, as well as prescription options including retinoid-based products, however the cutaneous irritation potential of topical acne active ingredients has been reported in the literature, which is not desirable in particular for patients with sensitive skin. Research has shown the benefits of red and blue light therapy in the treatment of mild to moderate acne, with blue light reported to target acne-causing bacteria and red light demonstrating anti-inflammatory activity. Previous studies with these types of modalities have shown high tolerance and efficacy. This study will look to evaluate the tolerance of a light therapy-based medical device in patients with self-reported sensitive skin.

Interventions

DEVICEAcne Mask

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to 40 Years

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Cutaneous Tolerance Scores: Tightness/Dry Feeling	Baseline to Day 28	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.
Cutaneous Tolerance Scores: Erythema	Baseline to Day 28	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.
Cutaneous Tolerance Scores: Dryness/Scaling	Baseline to Day 28	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.
Cutaneous Tolerance Scores: Edema	Baseline to Day 28	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.
Cutaneous Tolerance Scores: Burning/Stinging	Baseline to Day 28	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.
Cutaneous Tolerance Scores: Itching	Baseline to Day 28	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.

Secondary

Measure	Time frame	Description
Cutaneous Tolerance Scores: Erythema	Baseline to Day 14	Cutaneous Tolerance Scores: Erythema (assessing skin redness), from Baseline to Day 14. Scale range is 0-3 where 0 = no redness, 1 = mild redness, 2 = moderate redness, and 3 = severe redness.
Cutaneous Tolerance Scores: Dryness/Scaling	Baseline to Day 14	Cutaneous Tolerance Scores: Dryness/Scaling (assessing skin dryness), from Baseline to Day 14. Scale range is 0-3, where 0 = no dryness, 1 = mild dryness, 2 = moderate dryness, and 3 = severe dryness.
Cutaneous Tolerance Scores: Edema	Baseline to Day 14	Cutaneous Tolerance Scores: Edema (assessing skin edema/swelling), from Baseline to Day 14. Scale range is 0-3 where 0 = no edema, 1 = mild edema, 2 = moderate edema, and 3 = severe edema.
Cutaneous Tolerance Scores: Burning/Stinging	Baseline to Day 14	Cutaneous Tolerance Scores: Burning/Stinging (assessing skin burning/stinging), from Baseline to Day 14. Scale range is 0-3 where 0 = no burning/stinging, 1 = mild burning/stinging, 2 = moderate burning/stinging, and 3 = severe burning/stinging.
Cutaneous Tolerance Scores: Itching	Baseline to Day 14	Cutaneous Tolerance Scores: Itching (assessing skin itching), from Baseline to Day 14. Scale range is 0-3 where 0 = no itching, 1 = mild itching, 2 = moderate itching, and 3 = severe itching.
Cutaneous Tolerance Scores: Tightness/Dry	Baseline to Day 14	Cutaneous Tolerance Scores: Tightness/Dry Feeling (assessing skin tightness/dry feeling), from Baseline to Day 14. 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.

Countries

United States

Participant flow

Recruitment details

Recruitment Period: April 04, 2017, to May 10, 2017. Location: Clinical site.

Participants by arm

Arm	Count
Acne Mask 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.	45
Total	45

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Withdrawal by Subject	2

Baseline characteristics

Characteristic	Acne Mask
Age, Continuous	24 Years STANDARD_DEVIATION 8.4
Do you consider your facial skin to be sensitive? All of the time	19 Participants
Do you consider your facial skin to be sensitive? Most of the time	26 Participants
Do you consider your facial skin to be sensitive? None of the time	0 Participants
Do you consider your facial skin to be sensitive? Some of the time	0 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	44 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Fitzpatrick skin type I	0 Participants
Fitzpatrick skin type II	15 Participants
Fitzpatrick skin type III	11 Participants
Fitzpatrick skin type IV	6 Participants
Fitzpatrick skin type V	4 Participants
Fitzpatrick skin type VI	9 Participants
Have you ever been told by a skin care professional that you have sensitive skin on your face? No	30 Participants
Have you ever been told by a skin care professional that you have sensitive skin on your face? Yes	15 Participants
In the past, have you ever experienced skin irritation when using topical acne treatments? No	7 Participants
In the past, have you ever experienced skin irritation when using topical acne treatments? Yes	38 Participants
In the past, have you ever stopped using a topical acne treatment due to skin irritation No	20 Participants
In the past, have you ever stopped using a topical acne treatment due to skin irritation Yes	25 Participants
Investigator's global acne assessment 0 (clear)	0 Participants
Investigator's global acne assessment 1 (Almost clear)	0 Participants
Investigator's global acne assessment 2 (mild)	28 Participants
Investigator's global acne assessment 3 (moderate)	17 Participants
Investigator's global acne assessment 4 (severe)	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	2 Participants
Race (NIH/OMB) Black or African American	11 Participants
Race (NIH/OMB) More than one race	1 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants
Race (NIH/OMB) White	30 Participants
Sex: Female, Male Female	38 Participants
Sex: Female, Male Male	7 Participants
When purchasing skincare products, do you look for products labeled for sensitive skin or similar? No	3 Participants
When purchasing skincare products, do you look for products labeled for sensitive skin or similar? Yes	42 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 45
other Total, other adverse events	0 / 45
serious Total, serious adverse events	0 / 45

Outcome results

Primary

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.

Time frame: Baseline to Day 28

Arm	Measure	Value (MEAN)	Dispersion
Acne Mask	Cutaneous Tolerance Scores: Burning/Stinging	0.00 Units on a scale	Standard Deviation 0

Primary

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.

Time frame: Baseline to Day 28

Arm	Measure	Value (MEAN)	Dispersion
Acne Mask	Cutaneous Tolerance Scores: Dryness/Scaling	-0.14 Units on a scale	Standard Deviation 0.41

Primary

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.

Time frame: Baseline to Day 28

Arm	Measure	Value (MEAN)	Dispersion
Acne Mask	Cutaneous Tolerance Scores: Edema	0.00 Units on a scale	Standard Deviation 0

Primary

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.

Time frame: Baseline to Day 28

Arm	Measure	Value (MEAN)	Dispersion
Acne Mask	Cutaneous Tolerance Scores: Erythema	-0.07 Units on a scale	Standard Deviation 0.34

Primary

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.

Time frame: Baseline to Day 28

Arm	Measure	Value (MEAN)	Dispersion
Acne Mask	Cutaneous Tolerance Scores: Itching	0.00 Units on a scale	Standard Deviation 0

Primary

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.

Time frame: Baseline to Day 28

Arm	Measure	Value (MEAN)	Dispersion
Acne Mask	Cutaneous Tolerance Scores: Tightness/Dry Feeling	-0.05 Units on a scale	Standard Deviation 0.21

Secondary

Cutaneous Tolerance Scores: Burning/Stinging

Cutaneous Tolerance Scores: Burning/Stinging (assessing skin burning/stinging), from Baseline to Day 14. Scale range is 0-3 where 0 = no burning/stinging, 1 = mild burning/stinging, 2 = moderate burning/stinging, and 3 = severe burning/stinging.