| Primary | Change From Baseline in Melasma Severity Rating Scale Score to Week 12 | 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. | 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. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Day 1) to Week 12 | facial sides | facial sides | | ID | Title | Description |
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| OG000 | Lytera 2.0 | 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. | | OG001 | 4% Hydroquinone Topical Cream | 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. |
| | Units | Counts |
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| Participants | | | facial sides | |
| | Title | Denominators | Categories |
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| Baseline | | | Title | Measurements |
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| - OG0002.1± 0.3
- OG0012.1± 0.3
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| | Change from Baseline to Week 12 | | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| Testing hypothesis was that the mean change from baseline was zero. | Paired t-test | | 0.041 | | | | | | | | | | | | | | Other | | | | Testing hypothesis was that the mean change from baseline was zero. | Paired t-test |
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| Primary | Change From Baseline in Overall Hyperpigmentation Scale Score to Week 12 | 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. | 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. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Day 1) to Week 12 | facial sides | facial sides | | ID | Title | Description |
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| OG000 | Lytera 2.0 | 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. | | OG001 | 4% Hydroquinone Topical Cream | |
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| Primary | Change From Baseline in Melasma Area and Severity Index (MASI) Score 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. | 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. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Day1) to Week 12 | facial sides | facial sides | | ID | Title | Description |
|---|
| OG000 | Lytera 2.0 | 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. | | OG001 | 4% Hydroquinone Topical Cream | 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. |
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| Secondary | Number of Participants by Responses for Self-Assessment Questionnaire: Overall Improvement in Skin Condition | 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). | 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. | Posted | | Count of Participants | | Participants | | Baseline (Day 1) to Weeks 4, 8 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Lytera 2.0 | 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. | | OG001 | 4% Hydroquinone Topical Cream |
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| Secondary | Number of Participants by Responses for Self-Assessment Questionnaire: Overall Satisfaction With the Test Product | 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). | 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. | Posted | | Count of Participants | | Participants | | Weeks 4, 8 and 12 | | | | ID | Title | Description |
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| OG000 | Lytera 2.0 | 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. | | OG001 | 4% Hydroquinone Topical Cream | 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. |
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| Secondary | Number of Participants by Responses for Self-Assessment Questionnaire: Test Product Preference | Using the Subject Self-Assessment Questionnaire: Facial Side Preference, the participant selected based on their experience, the Test Product they preferred to use. | 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. | Posted | | Count of Participants | | Participants | | Weeks 4, 8 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Lytera 2.0 | 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. | | OG001 | 4% Hydroquinone Topical Cream | 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. |
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| Secondary | Change From Baseline in Melasma Quality of Life (MELASQOL) Scale Total Score 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. | 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. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Day 1) to Week 12 | facial sides | facial sides | | ID | Title | Description |
|---|
| OG000 | Lytera 2.0 | 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. |
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| Secondary | Investigator's Global Improvement Assessment for Overall Hyperpigmentation Score to 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. | 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. | Posted | | Mean | Standard Deviation | score on a scale | | Week 12 | facial sides | facial sides | | ID | Title | Description |
|---|
| OG000 | Lytera 2.0 | 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. | | OG001 | 4% Hydroquinone Topical Cream | 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. |
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| Secondary | Change From Baseline in Mexameter Measurement of Target Hyperpigmentation Lesion 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. | 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. | Posted | | Mean | Standard Deviation | AU | | Baseline (Day 1) to Week 12 | facial sides | facial sides | | ID | Title | Description |
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| OG000 | Lytera 2.0 | 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. | | OG001 | 4% Hydroquinone Topical Cream | 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. |
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