18 and older, any sex, with Melasma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in Melasma Severity Rating Scale Score to Week 12Primary· Baseline (Day 1) 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
Baseline
Group
Value
95% CI
Lytera 2.0
2.1
± 0.3
4% Hydroquinone Topical Cream
2.1
± 0.3
Change from Baseline to Week 12
Group
Value
95% CI
Lytera 2.0
-0.3
± 0.4
4% Hydroquinone Topical Cream
-0.8
± 0.7
Change From Baseline in Overall Hyperpigmentation Scale Score to Week 12Primary· Baseline (Day 1) 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 pigme
Baseline
Group
Value
95% CI
Lytera 2.0
4.8
± 1.1
4% Hydroquinone Topical Cream
4.8
± 1.1
Change from Baseline to Week 12
Group
Value
95% CI
Lytera 2.0
-0.8
± 1.0
4% Hydroquinone Topical Cream
-1.7
± 1.3
Change From Baseline in Melasma Area and Severity Index (MASI) Score to Week 12Primary· 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.
Baseline
Group
Value
95% CI
Lytera 2.0
9.0
± 3.9
4% Hydroquinone Topical Cream
8.9
± 3.8
Change from Baseline to Week 12
Group
Value
95% CI
Lytera 2.0
-1.2
± 1.8
4% Hydroquinone Topical Cream
-3.1
± 3.5
Number of Participants by Responses for Self-Assessment Questionnaire: Overall Improvement in Skin ConditionSecondary· 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% ove
Week 4: 0- No change
Group
Value
95% CI
Lytera 2.0
5
4% Hydroquinone Topical Cream
2
Week 4: 1- Slight improvement
Group
Value
95% CI
Lytera 2.0
8
4% Hydroquinone Topical Cream
11
Week 4: 2- Moderate improvement
Group
Value
95% CI
Lytera 2.0
3
4% Hydroquinone Topical Cream
3
Week 4: 3- Marked improvement
Group
Value
95% CI
Lytera 2.0
1
4% Hydroquinone Topical Cream
2
Week 4: 4- Complete clearing of skin
Group
Value
95% CI
Lytera 2.0
0
4% Hydroquinone Topical Cream
0
Week 8: 0- No change
Group
Value
95% CI
Lytera 2.0
2
4% Hydroquinone Topical Cream
0
Week 8: 1- Slight improvement
Group
Value
95% CI
Lytera 2.0
7
4% Hydroquinone Topical Cream
5
Week 8: 2- Moderate improvement
Group
Value
95% CI
Lytera 2.0
3
4% Hydroquinone Topical Cream
4
Number of Participants by Responses for Self-Assessment Questionnaire: Overall Satisfaction With the Test ProductSecondary· 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).
Week 4: 1- Excellent (very satisfied)
Group
Value
95% CI
Lytera 2.0
3
4% Hydroquinone Topical Cream
6
Week 4: 2- Good (moderately satisfied)
Group
Value
95% CI
Lytera 2.0
9
4% Hydroquinone Topical Cream
9
Week 4: 3- Fair (slightly satisfied)
Group
Value
95% CI
Lytera 2.0
5
4% Hydroquinone Topical Cream
3
Week 4: 4- Poor (not satisfied at all)
Group
Value
95% CI
Lytera 2.0
1
4% Hydroquinone Topical Cream
0
Week 8: 1- Excellent (very satisfied)
Group
Value
95% CI
Lytera 2.0
4
4% Hydroquinone Topical Cream
7
Week 8: 2- Good (moderately satisfied)
Group
Value
95% CI
Lytera 2.0
7
4% Hydroquinone Topical Cream
8
Week 8: 3- Fair (slightly satisfied)
Group
Value
95% CI
Lytera 2.0
4
4% Hydroquinone Topical Cream
1
Week 8: 4- Poor (not satisfied at all)
Group
Value
95% CI
Lytera 2.0
1
4% Hydroquinone Topical Cream
0
Number of Participants by Responses for Self-Assessment Questionnaire: Test Product PreferenceSecondary· 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.
Week 4
Group
Value
95% CI
Lytera 2.0
6
4% Hydroquinone Topical Cream
12
Week 8
Group
Value
95% CI
Lytera 2.0
3
4% Hydroquinone Topical Cream
13
Week 12
Group
Value
95% CI
Lytera 2.0
3
4% Hydroquinone Topical Cream
13
Change From Baseline in Melasma Quality of Life (MELASQOL) Scale Total Score to Week 12Secondary· 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
Baseline
Group
Value
95% CI
Lytera 2.0
45.9
± 19.0
4% Hydroquinone Topical Cream
46.2
± 19.5
Change from Baseline to Week 12
Group
Value
95% CI
Lytera 2.0
-15.0
± 16.3
4% Hydroquinone Topical Cream
-21.7
± 19.5
Investigator's Global Improvement Assessment for Overall Hyperpigmentation Score to Week 12Secondary· 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.
Group
Value
95% CI
Lytera 2.0
1.1
± 0.9
4% Hydroquinone Topical Cream
1.8
± 1.2
Change From Baseline in Mexameter Measurement of Target Hyperpigmentation Lesion to Week 12Secondary· 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.
Baseline (Melanin index)
Group
Value
95% CI
Lytera 2.0
581.1
± 79.7
4% Hydroquinone Topical Cream
587.1
± 73.4
Normal Skin
544.5
± 64.1
Change from Baseline to Week 12 (Melanin index)
Group
Value
95% CI
Lytera 2.0
-3.0
± 27.5
4% Hydroquinone Topical Cream
-26.5
± 21.6
Normal Skin
-2.4
± 32.8
Baseline (Erythema)
Group
Value
95% CI
Lytera 2.0
578.9
± 37.8
4% Hydroquinone Topical Cream
584.5
± 27.6
Normal Skin
572.7
± 36.0
Change from Baseline to Week 12 (Erythema)
Group
Value
95% CI
Lytera 2.0
3.4
± 26.2
4% Hydroquinone Topical Cream
-0.1
± 14.6
Normal Skin
9.4
± 25.0
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dose of study drug up to 12 weeks.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The objective of this study is to evaluate the efficacy and tolerability of Lytera 2.0 versus 4% hydroquinone in the improvement of the appearance of moderate facial melasma.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Allergan
Last refreshed: 19 December 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02977507.