Trial Outcomes & Findings for Split-face Study Comparing the Cosmetic Efficacy and Tolerability of Two Topical Products in Participants With Moderate Facial Melasma (NCT NCT02977507)

Last Updated: 2018-12-19

Results Overview

The investigator assessed the participant's facial skin for the severity of symmetrical facial melasma on the left and the right side of the face using the Melasma Severity Rating Scale. The score ranges from 0 to 3, where 0=Cleared: color of melasma lesions approximately equivalent to surrounding normal skin or with minimal residual hyperpigmentation, 1=Mild: color slightly darker than the surrounding normal skin, 2=Moderate: color moderately darker than the surrounding normal skin and 3=Severe: color markedly darker than the surrounding normal skin. A negative change from Baseline indicates improvement.

Recruitment status

COMPLETED

Study phase

Target enrollment

18 participants

Primary outcome timeframe

Baseline (Day 1) to Week 12

Results posted on

2018-12-19

Participant Flow

Participant milestones

Participant milestones
Measure	Left Side Lytera 2.0, Right Side 4% Hydroquinone Lytera 2.0 applied to the affected areas (dark patches) on the left side of the face and 4% hydroquinone topical prescription cream applied to the affected areas on the right side of the face twice a day, in the morning and evening, every day for 12 weeks. SkinMedica Facial Cleanser, SkinMedica Rejuvenative Moisturizer, and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen were also applied to the face as directed.	Left Side 4% Hydroquinone, Right Side Lytera 2.0 4% hydroquinone topical prescription cream applied to the affected areas (dark patches) on the left side of the face and Lytera 2.0 applied to the affected areas on the right side of the face twice a day, in the morning and evening, every day for 12 weeks. SkinMedica Facial Cleanser, SkinMedica Rejuvenative Moisturizer, and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen were also applied to the face as directed.
Overall Study STARTED	8	10
Overall Study COMPLETED	6	10
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Left Side Lytera 2.0, Right Side 4% Hydroquinone Lytera 2.0 applied to the affected areas (dark patches) on the left side of the face and 4% hydroquinone topical prescription cream applied to the affected areas on the right side of the face twice a day, in the morning and evening, every day for 12 weeks. SkinMedica Facial Cleanser, SkinMedica Rejuvenative Moisturizer, and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen were also applied to the face as directed.	Left Side 4% Hydroquinone, Right Side Lytera 2.0 4% hydroquinone topical prescription cream applied to the affected areas (dark patches) on the left side of the face and Lytera 2.0 applied to the affected areas on the right side of the face twice a day, in the morning and evening, every day for 12 weeks. SkinMedica Facial Cleanser, SkinMedica Rejuvenative Moisturizer, and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen were also applied to the face as directed.
Overall Study Protocol Deviation	1	0
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Split-face Study Comparing the Cosmetic Efficacy and Tolerability of Two Topical Products in Participants With Moderate Facial Melasma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=18 Participants Participants were randomized to one of two treatment groups: "Left side Lytera 2.0, Right side 4% hydroquinone" or "Left Side 4% hydroquinone, Right Side Lytera 2.0". Lytera 2.0 applied to the affected areas (dark patches) on one side of the face and 4% hydroquinone topical prescription cream applied to the affected areas on the other side of the face twice a day, in the morning and evening, every day for 12 weeks. SkinMedica Facial Cleanser, SkinMedica Rejuvenative Moisturizer, and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen were also applied to the face as directed.
Age, Continuous	53 years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	9 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants
Race/Ethnicity, Customized African American	6 Participants n=5 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) to Week 12

Population: Intent-to-treat (ITT) Population included all enrolled participants with at least one follow-up visit. Number analyzed is the number of participants with data available for analysis at the given time-point.

Outcome measures

Outcome measures
Measure	Lytera 2.0 n=16 Participants Lytera 2.0 applied to the affected areas (dark patches) on one side of the face twice a day, in the morning and evening, every day for 12 weeks. SkinMedica Facial Cleanser, SkinMedica Rejuvenative Moisturizer, and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen were also applied to the face as directed.	4% Hydroquinone Topical Cream n=16 facial sides 4% hydroquinone topical prescription cream applied to the affected areas (dark patches) on the other side of the face twice a day, in the morning and evening, every day for 12 weeks. SkinMedica Facial Cleanser, SkinMedica Rejuvenative Moisturizer, and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen were also applied to the face as directed.	Normal Skin Mexameter measurements were taken of the participant's normal skin.
Change From Baseline in Melasma Severity Rating Scale Score to Week 12 Baseline	2.1 score on a scale Standard Deviation 0.3	2.1 score on a scale Standard Deviation 0.3	—
Change From Baseline in Melasma Severity Rating Scale Score to Week 12 Change from Baseline to Week 12	-0.3 score on a scale Standard Deviation 0.4	-0.8 score on a scale Standard Deviation 0.7	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to Week 12

Population: ITT population included all enrolled participants with at least one follow-up visit. Number analyzed is the number of participants with data available for analysis at the given time-point.

The investigator assessed the participant's left and right facial sides for overall hyperpigmentation using the Overall Hyperpigmentation ten-point scale ranging from 0 to 9, where Score 0=None, skin is normal in color with no evidence of hyperpigmentation; Score 1, 2 or 3=Mild, several brown spots with increased pigmentation, they are small in size and slightly darker than surrounding skin; Score 4, 5 or 6=Moderate, many brown spots with increased pigmentation, they are medium in size and much darker than surrounding skin; Score of 7, 8 or 9=Severe, many large brown spots with increased pigmentation, they are large in size and markedly darker than surrounding skin. A negative change from Baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Lytera 2.0 n=18 facial sides Lytera 2.0 applied to the affected areas (dark patches) on one side of the face twice a day, in the morning and evening, every day for 12 weeks. SkinMedica Facial Cleanser, SkinMedica Rejuvenative Moisturizer, and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen were also applied to the face as directed.	4% Hydroquinone Topical Cream n=18 facial sides 4% hydroquinone topical prescription cream applied to the affected areas (dark patches) on the other side of the face twice a day, in the morning and evening, every day for 12 weeks. SkinMedica Facial Cleanser, SkinMedica Rejuvenative Moisturizer, and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen were also applied to the face as directed.	Normal Skin Mexameter measurements were taken of the participant's normal skin.
Change From Baseline in Overall Hyperpigmentation Scale Score to Week 12 Baseline	4.8 score on a scale Standard Deviation 1.1	4.8 score on a scale Standard Deviation 1.1	—
Change From Baseline in Overall Hyperpigmentation Scale Score to Week 12 Change from Baseline to Week 12	-0.8 score on a scale Standard Deviation 1.0	-1.7 score on a scale Standard Deviation 1.3	—

PRIMARY outcome

Timeframe: Baseline (Day1) to Week 12

The investigator assigned a grade for the left and right facial sides for each of the following: A=Total Area Involved (0=No involvement to 6=90 to 100% involvement); D=Darkness of Pigment (0=Normal skin color to 4=Severe hyperpigmentation); and H=Homogeneity (0=Normal skin color without evidence of hyperpigmentation to 4=Uniform skin involvement without any clear areas). Total Half-Face MASI score was calculated as: Half Forehead 0.15(D+H)A + One Malar Side 0.3 (D+H)A + Half Chin 0.05(D+H)A. A negative change from Baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Lytera 2.0 n=18 facial sides Lytera 2.0 applied to the affected areas (dark patches) on one side of the face twice a day, in the morning and evening, every day for 12 weeks. SkinMedica Facial Cleanser, SkinMedica Rejuvenative Moisturizer, and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen were also applied to the face as directed.	4% Hydroquinone Topical Cream n=18 facial sides 4% hydroquinone topical prescription cream applied to the affected areas (dark patches) on the other side of the face twice a day, in the morning and evening, every day for 12 weeks. SkinMedica Facial Cleanser, SkinMedica Rejuvenative Moisturizer, and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen were also applied to the face as directed.	Normal Skin Mexameter measurements were taken of the participant's normal skin.
Change From Baseline in Melasma Area and Severity Index (MASI) Score to Week 12 Baseline	9.0 score on a scale Standard Deviation 3.9	8.9 score on a scale Standard Deviation 3.8	—
Change From Baseline in Melasma Area and Severity Index (MASI) Score to Week 12 Change from Baseline to Week 12	-1.2 score on a scale Standard Deviation 1.8	-3.1 score on a scale Standard Deviation 3.5	—

SECONDARY outcome

Timeframe: Baseline (Day 1) to Weeks 4, 8 and 12

Using the Subject Self-Assessment Questionnaire: Overall Improvement, the participant selected a response that best represented their feelings on the overall improvement in their skin condition compared to the beginning of the study. Responses were categorized as: 0=No change or a worsening in my skin condition (dark areas of color on skin), 1=I see a slight improvement in my skin condition (approximately 25% overall improvement), 2=I see a moderate improvement in my skin condition (approximately 50% overall improvement), 3=I see a marked improvement in my skin condition (approximately 75% overall improvement), 4=I see a complete clearing of my skin condition (approximately 95% or better overall improvement).

Outcome measures

Outcome measures
Measure	Lytera 2.0 n=18 Participants Lytera 2.0 applied to the affected areas (dark patches) on one side of the face twice a day, in the morning and evening, every day for 12 weeks. SkinMedica Facial Cleanser, SkinMedica Rejuvenative Moisturizer, and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen were also applied to the face as directed.	4% Hydroquinone Topical Cream n=18 Participants 4% hydroquinone topical prescription cream applied to the affected areas (dark patches) on the other side of the face twice a day, in the morning and evening, every day for 12 weeks. SkinMedica Facial Cleanser, SkinMedica Rejuvenative Moisturizer, and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen were also applied to the face as directed.	Normal Skin Mexameter measurements were taken of the participant's normal skin.
Number of Participants by Responses for Self-Assessment Questionnaire: Overall Improvement in Skin Condition Week 4: 0- No change	5 Participants	2 Participants	—
Number of Participants by Responses for Self-Assessment Questionnaire: Overall Improvement in Skin Condition Week 4: 1- Slight improvement	8 Participants	11 Participants	—
Number of Participants by Responses for Self-Assessment Questionnaire: Overall Improvement in Skin Condition Week 4: 2- Moderate improvement	3 Participants	3 Participants	—
Number of Participants by Responses for Self-Assessment Questionnaire: Overall Improvement in Skin Condition Week 4: 3- Marked improvement	1 Participants	2 Participants	—
Number of Participants by Responses for Self-Assessment Questionnaire: Overall Improvement in Skin Condition Week 4: 4- Complete clearing of skin	0 Participants	0 Participants	—
Number of Participants by Responses for Self-Assessment Questionnaire: Overall Improvement in Skin Condition Week 8: 0- No change	2 Participants	0 Participants	—
Number of Participants by Responses for Self-Assessment Questionnaire: Overall Improvement in Skin Condition Week 8: 1- Slight improvement	7 Participants	5 Participants	—
Number of Participants by Responses for Self-Assessment Questionnaire: Overall Improvement in Skin Condition Week 8: 2- Moderate improvement	3 Participants	4 Participants	—
Number of Participants by Responses for Self-Assessment Questionnaire: Overall Improvement in Skin Condition Week 8: 3- Marked improvement	2 Participants	4 Participants	—
Number of Participants by Responses for Self-Assessment Questionnaire: Overall Improvement in Skin Condition Week 8: 4- Complete clearing of skin	2 Participants	3 Participants	—
Number of Participants by Responses for Self-Assessment Questionnaire: Overall Improvement in Skin Condition Week 12: 0- No change	4 Participants	1 Participants	—
Number of Participants by Responses for Self-Assessment Questionnaire: Overall Improvement in Skin Condition Week 12: 1- Slight improvement	2 Participants	2 Participants	—
Number of Participants by Responses for Self-Assessment Questionnaire: Overall Improvement in Skin Condition Week 12: 2- Moderate improvement	5 Participants	3 Participants	—
Number of Participants by Responses for Self-Assessment Questionnaire: Overall Improvement in Skin Condition Week 12: 3- Marked improvement	5 Participants	8 Participants	—
Number of Participants by Responses for Self-Assessment Questionnaire: Overall Improvement in Skin Condition Week 12: 4- Complete clearing of skin	0 Participants	2 Participants	—

SECONDARY outcome

Timeframe: Weeks 4, 8 and 12

Using the Subject Self-Assessment Questionnaire: Satisfaction with Treatment, the participant selected a response that best represented their overall satisfaction with the test product. Responses were categorized as: 1=Excellent (very satisfied), 2=Good (moderately satisfied), 3=Fair (slightly satisfied) and 4=Poor (not satisfied at all).

Outcome measures

Outcome measures
Measure	Lytera 2.0 n=18 Participants Lytera 2.0 applied to the affected areas (dark patches) on one side of the face twice a day, in the morning and evening, every day for 12 weeks. SkinMedica Facial Cleanser, SkinMedica Rejuvenative Moisturizer, and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen were also applied to the face as directed.	4% Hydroquinone Topical Cream n=18 Participants 4% hydroquinone topical prescription cream applied to the affected areas (dark patches) on the other side of the face twice a day, in the morning and evening, every day for 12 weeks. SkinMedica Facial Cleanser, SkinMedica Rejuvenative Moisturizer, and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen were also applied to the face as directed.	Normal Skin Mexameter measurements were taken of the participant's normal skin.
Number of Participants by Responses for Self-Assessment Questionnaire: Overall Satisfaction With the Test Product Week 4: 1- Excellent (very satisfied)	3 Participants	6 Participants	—
Number of Participants by Responses for Self-Assessment Questionnaire: Overall Satisfaction With the Test Product Week 4: 2- Good (moderately satisfied)	9 Participants	9 Participants	—
Number of Participants by Responses for Self-Assessment Questionnaire: Overall Satisfaction With the Test Product Week 4: 3- Fair (slightly satisfied)	5 Participants	3 Participants	—
Number of Participants by Responses for Self-Assessment Questionnaire: Overall Satisfaction With the Test Product Week 4: 4- Poor (not satisfied at all)	1 Participants	0 Participants	—
Number of Participants by Responses for Self-Assessment Questionnaire: Overall Satisfaction With the Test Product Week 8: 1- Excellent (very satisfied)	4 Participants	7 Participants	—
Number of Participants by Responses for Self-Assessment Questionnaire: Overall Satisfaction With the Test Product Week 8: 2- Good (moderately satisfied)	7 Participants	8 Participants	—
Number of Participants by Responses for Self-Assessment Questionnaire: Overall Satisfaction With the Test Product Week 8: 3- Fair (slightly satisfied)	4 Participants	1 Participants	—
Number of Participants by Responses for Self-Assessment Questionnaire: Overall Satisfaction With the Test Product Week 8: 4- Poor (not satisfied at all)	1 Participants	0 Participants	—
Number of Participants by Responses for Self-Assessment Questionnaire: Overall Satisfaction With the Test Product Week 12: 1- Excellent (very satisfied)	5 Participants	5 Participants	—
Number of Participants by Responses for Self-Assessment Questionnaire: Overall Satisfaction With the Test Product Week 12: 2- Good (moderately satisfied)	2 Participants	8 Participants	—
Number of Participants by Responses for Self-Assessment Questionnaire: Overall Satisfaction With the Test Product Week 12: 3- Fair (slightly satisfied)	6 Participants	2 Participants	—
Number of Participants by Responses for Self-Assessment Questionnaire: Overall Satisfaction With the Test Product Week 12: 4- Poor (not satisfied at all)	3 Participants	1 Participants	—

SECONDARY outcome

Timeframe: Weeks 4, 8 and 12

Using the Subject Self-Assessment Questionnaire: Facial Side Preference, the participant selected based on their experience, the Test Product they preferred to use.

Outcome measures

Outcome measures
Measure	Lytera 2.0 n=18 Participants Lytera 2.0 applied to the affected areas (dark patches) on one side of the face twice a day, in the morning and evening, every day for 12 weeks. SkinMedica Facial Cleanser, SkinMedica Rejuvenative Moisturizer, and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen were also applied to the face as directed.	4% Hydroquinone Topical Cream n=18 Participants 4% hydroquinone topical prescription cream applied to the affected areas (dark patches) on the other side of the face twice a day, in the morning and evening, every day for 12 weeks. SkinMedica Facial Cleanser, SkinMedica Rejuvenative Moisturizer, and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen were also applied to the face as directed.	Normal Skin Mexameter measurements were taken of the participant's normal skin.
Number of Participants by Responses for Self-Assessment Questionnaire: Test Product Preference Week 4	6 Participants	12 Participants	—
Number of Participants by Responses for Self-Assessment Questionnaire: Test Product Preference Week 8	3 Participants	13 Participants	—
Number of Participants by Responses for Self-Assessment Questionnaire: Test Product Preference Week 12	3 Participants	13 Participants	—

SECONDARY outcome

Timeframe: Baseline (Day 1) to Week 12

The Melasma Quality of Life Scale assesses the effect melasma has on the quality of life of sufferers on a scale of 1 (not bothered at all) to 7 (bothered all of the time), rating the following questions: 1.The appearance of your skin condition 2.Frustration about your skin condition. 3.Embarrassment about your skin condition. 4.Feeling depressed about your skin condition. 5.The effects of your skin condition on your interactions with other people. 6.The effects of your skin condition on your desire to be with people. 7.Your skin condition making it hard to show affection. 8.Skin discoloration making you feel unattractive to others. 9.Skin discoloration making you feel less vital or productive. 10.Skin discoloration affecting your sense of freedom. The MELASQOL is scored from 7 to 70, with a higher score indicating worse melasma-related health-related quality of life. A negative change from Baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Lytera 2.0 n=15 facial sides Lytera 2.0 applied to the affected areas (dark patches) on one side of the face twice a day, in the morning and evening, every day for 12 weeks. SkinMedica Facial Cleanser, SkinMedica Rejuvenative Moisturizer, and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen were also applied to the face as directed.	4% Hydroquinone Topical Cream n=15 facial sides 4% hydroquinone topical prescription cream applied to the affected areas (dark patches) on the other side of the face twice a day, in the morning and evening, every day for 12 weeks. SkinMedica Facial Cleanser, SkinMedica Rejuvenative Moisturizer, and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen were also applied to the face as directed.	Normal Skin Mexameter measurements were taken of the participant's normal skin.
Change From Baseline in Melasma Quality of Life (MELASQOL) Scale Total Score to Week 12 Baseline	45.9 score on a scale Standard Deviation 19.0	46.2 score on a scale Standard Deviation 19.5	—
Change From Baseline in Melasma Quality of Life (MELASQOL) Scale Total Score to Week 12 Change from Baseline to Week 12	-15.0 score on a scale Standard Deviation 16.3	-21.7 score on a scale Standard Deviation 19.5	—

SECONDARY outcome

Timeframe: Week 12

Investigator's global improvement assessment score was used for assessment of overall hyperpigmentation on the left and right facial sides. The score ranged from 0 to 4 where, 0=No change or worsening, 1=Mild improvement (approximately 25% overall improvement), 2=Moderate improvement (approximately 50% overall improvement), 3=Marked improvement (approximately 75% overall improvement), 4=Complete clearing/Dramatic improvement (approximately 95% plus overall improvement). The mean score for overall hyperpigmentation was reported.

Outcome measures

Outcome measures
Measure	Lytera 2.0 n=16 facial sides Lytera 2.0 applied to the affected areas (dark patches) on one side of the face twice a day, in the morning and evening, every day for 12 weeks. SkinMedica Facial Cleanser, SkinMedica Rejuvenative Moisturizer, and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen were also applied to the face as directed.	4% Hydroquinone Topical Cream n=16 facial sides 4% hydroquinone topical prescription cream applied to the affected areas (dark patches) on the other side of the face twice a day, in the morning and evening, every day for 12 weeks. SkinMedica Facial Cleanser, SkinMedica Rejuvenative Moisturizer, and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen were also applied to the face as directed.	Normal Skin Mexameter measurements were taken of the participant's normal skin.
Investigator's Global Improvement Assessment for Overall Hyperpigmentation Score to Week 12	1.1 score on a scale Standard Deviation 0.9	1.8 score on a scale Standard Deviation 1.2	—

SECONDARY outcome

Timeframe: Baseline (Day 1) to Week 12

Two target hyperpigmented lesions were selected from the left and the right malar facial areas and were measured by the mexameter, an instrument that measures melanin content. One target "normal" measurement was also taken from an unaffected skin area on the face representing normal skin. The values from the target hyperpigmented lesions were compared to the normal lesion value. The range of melamin index and erythema is 0 to 999 Arbitrary Units (AU). A negative change from Baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Lytera 2.0 n=18 facial sides Lytera 2.0 applied to the affected areas (dark patches) on one side of the face twice a day, in the morning and evening, every day for 12 weeks. SkinMedica Facial Cleanser, SkinMedica Rejuvenative Moisturizer, and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen were also applied to the face as directed.	4% Hydroquinone Topical Cream n=18 facial sides 4% hydroquinone topical prescription cream applied to the affected areas (dark patches) on the other side of the face twice a day, in the morning and evening, every day for 12 weeks. SkinMedica Facial Cleanser, SkinMedica Rejuvenative Moisturizer, and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen were also applied to the face as directed.	Normal Skin n=18 facial sides Mexameter measurements were taken of the participant's normal skin.
Change From Baseline in Mexameter Measurement of Target Hyperpigmentation Lesion to Week 12 Baseline (Melanin index)	581.1 AU Standard Deviation 79.7	587.1 AU Standard Deviation 73.4	544.5 AU Standard Deviation 64.1
Change From Baseline in Mexameter Measurement of Target Hyperpigmentation Lesion to Week 12 Change from Baseline to Week 12 (Melanin index)	-3.0 AU Standard Deviation 27.5	-26.5 AU Standard Deviation 21.6	-2.4 AU Standard Deviation 32.8
Change From Baseline in Mexameter Measurement of Target Hyperpigmentation Lesion to Week 12 Baseline (Erythema)	578.9 AU Standard Deviation 37.8	584.5 AU Standard Deviation 27.6	572.7 AU Standard Deviation 36.0
Change From Baseline in Mexameter Measurement of Target Hyperpigmentation Lesion to Week 12 Change from Baseline to Week 12 (Erythema)	3.4 AU Standard Deviation 26.2	-0.1 AU Standard Deviation 14.6	9.4 AU Standard Deviation 25.0

Adverse Events

Left Side Lytera 2.0, Right Side 4% Hydroquinone

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Left Side 4% Hydroquinone, Right Side Lytera 2.0

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Left Side Lytera 2.0, Right Side 4% Hydroquinone n=8 participants at risk Lytera 2.0 applied to the affected areas (dark patches) on the left side of the face and 4% hydroquinone topical prescription cream applied to the affected areas on the right side of the face twice a day, in the morning and evening, every day for 12 weeks. SkinMedica Facial Cleanser, SkinMedica Rejuvenative Moisturizer, and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen were also applied to the face as directed.	Left Side 4% Hydroquinone, Right Side Lytera 2.0 n=10 participants at risk 4% hydroquinone topical prescription cream applied to the affected areas (dark patches) on the left side of the face and Lytera 2.0 applied to the affected areas on the right side of the face twice a day, in the morning and evening, every day for 12 weeks. SkinMedica Facial Cleanser, SkinMedica Rejuvenative Moisturizer, and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen were also applied to the face as directed.
Cardiac disorders Myocardial infarction	12.5% 1/8 • From first dose of study drug up to 12 weeks	0.00% 0/10 • From first dose of study drug up to 12 weeks

Other adverse events

Other adverse events
Measure	Left Side Lytera 2.0, Right Side 4% Hydroquinone n=8 participants at risk Lytera 2.0 applied to the affected areas (dark patches) on the left side of the face and 4% hydroquinone topical prescription cream applied to the affected areas on the right side of the face twice a day, in the morning and evening, every day for 12 weeks. SkinMedica Facial Cleanser, SkinMedica Rejuvenative Moisturizer, and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen were also applied to the face as directed.	Left Side 4% Hydroquinone, Right Side Lytera 2.0 n=10 participants at risk 4% hydroquinone topical prescription cream applied to the affected areas (dark patches) on the left side of the face and Lytera 2.0 applied to the affected areas on the right side of the face twice a day, in the morning and evening, every day for 12 weeks. SkinMedica Facial Cleanser, SkinMedica Rejuvenative Moisturizer, and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen were also applied to the face as directed.
Infections and infestations Nasopharyngitis	12.5% 1/8 • From first dose of study drug up to 12 weeks	0.00% 0/10 • From first dose of study drug up to 12 weeks
Gastrointestinal disorders Lip blister	12.5% 1/8 • From first dose of study drug up to 12 weeks	0.00% 0/10 • From first dose of study drug up to 12 weeks
Infections and infestations Influenza	25.0% 2/8 • From first dose of study drug up to 12 weeks	0.00% 0/10 • From first dose of study drug up to 12 weeks
Respiratory, thoracic and mediastinal disorders Cough	12.5% 1/8 • From first dose of study drug up to 12 weeks	0.00% 0/10 • From first dose of study drug up to 12 weeks
Gastrointestinal disorders Crohn's disease	12.5% 1/8 • From first dose of study drug up to 12 weeks	0.00% 0/10 • From first dose of study drug up to 12 weeks
Infections and infestations Urinary tract infection	0.00% 0/8 • From first dose of study drug up to 12 weeks	10.0% 1/10 • From first dose of study drug up to 12 weeks
Skin and subcutaneous tissue disorders Rash	0.00% 0/8 • From first dose of study drug up to 12 weeks	10.0% 1/10 • From first dose of study drug up to 12 weeks
Nervous system disorders Burning sensation	12.5% 1/8 • From first dose of study drug up to 12 weeks	0.00% 0/10 • From first dose of study drug up to 12 weeks
Skin and subcutaneous tissue disorders Dry skin	12.5% 1/8 • From first dose of study drug up to 12 weeks	0.00% 0/10 • From first dose of study drug up to 12 weeks
General disorders Pyrexia	0.00% 0/8 • From first dose of study drug up to 12 weeks	10.0% 1/10 • From first dose of study drug up to 12 weeks
Gastrointestinal disorders Abdominal pain upper	0.00% 0/8 • From first dose of study drug up to 12 weeks	10.0% 1/10 • From first dose of study drug up to 12 weeks
Nervous system disorders Headache	0.00% 0/8 • From first dose of study drug up to 12 weeks	10.0% 1/10 • From first dose of study drug up to 12 weeks
Respiratory, thoracic and mediastinal disorders Asthma	12.5% 1/8 • From first dose of study drug up to 12 weeks	0.00% 0/10 • From first dose of study drug up to 12 weeks

Additional Information

Therapeutic Area, Head

Allergan

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Publication restrictions are in place

Restriction type: OTHER