Trial · NCT02977507
Split-face Study Comparing the Cosmetic Efficacy and Tolerability of Two Topical Products in Participants With Moderate Facial Melasma
NCT02977507, Not applicable, Completed, Allergan; results first posted 2018-11-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Split-face Study Comparing the Cosmetic Efficacy and Tolerability of Two Topical Products in Participants With Moderate Facial Melasma. Trials, record NCT02977507. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02977507
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Split-face Study Comparing the Cosmetic Efficacy and Tolerability of Two Topical Products in Participants With Moderate Facial Melasma
- NCT number
- NCT02977507
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 18 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Melasma
- Interventions
- Lytera 2.0, 4% Hydroquinone Topical Cream, SkinMedica Facial Cleanser, SkinMedica Rejuvenative Moisturizer, SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen
- First posted
- 2016-11-30
- Last updated
- 2018-12-19
- Results first posted
- 2018-11-07
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Melasma Severity Rating Scale Score to Week 12 | 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 improvement. |
| Primary | Change From Baseline in Overall Hyperpigmentation Scale Score to Week 12 | 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 pigmentation, they are large in size and markedly darker than surrounding skin. A negative change from Baseline indicates improvement. |
| Primary | Change From Baseline in Melasma Area and Severity Index (MASI) Score to Week 12 | 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. |
| Secondary | Number of Participants by Responses for Self-Assessment Questionnaire: Overall Improvement in Skin Condition | 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). |
| Secondary | Number of Participants by Responses for Self-Assessment Questionnaire: Overall Satisfaction With the Test Product | 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). |
| Secondary | Number of Participants by Responses for Self-Assessment Questionnaire: Test Product Preference | 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. |
| Secondary | Change From Baseline in Melasma Quality of Life (MELASQOL) Scale Total Score to Week 12 | 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. |
| Secondary | Investigator's Global Improvement Assessment for Overall Hyperpigmentation Score to Week 12 | 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. |
| Secondary | Change From Baseline in Mexameter Measurement of Target Hyperpigmentation Lesion to Week 12 | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Melasma Severity Rating Scale Score to Week 12 | Baseline (Day 1) to Week 12 | 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. | score on a scale | MEAN |
| PRIMARY | Change From Baseline in Overall Hyperpigmentation Scale Score to Week 12 | Baseline (Day 1) to Week 12 | 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. | score on a scale | MEAN |
| PRIMARY | Change From Baseline in Melasma Area and Severity Index (MASI) Score to Week 12 | Baseline (Day1) to Week 12 | 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. | score on a scale | MEAN |
| SECONDARY | Number of Participants by Responses for Self-Assessment Questionnaire: Overall Improvement in Skin Condition | Baseline (Day 1) to Weeks 4, 8 and 12 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants by Responses for Self-Assessment Questionnaire: Overall Satisfaction With the Test Product | Weeks 4, 8 and 12 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants by Responses for Self-Assessment Questionnaire: Test Product Preference | Weeks 4, 8 and 12 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Melasma Quality of Life (MELASQOL) Scale Total Score to Week 12 | Baseline (Day 1) to Week 12 | 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. | score on a scale | MEAN |
| SECONDARY | Investigator's Global Improvement Assessment for Overall Hyperpigmentation Score to Week 12 | Week 12 | 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. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Mexameter Measurement of Target Hyperpigmentation Lesion to Week 12 | Baseline (Day 1) to Week 12 | 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. | AU | MEAN |
Source ClinicalTrials.gov
Results by group90
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Melasma Severity Rating Scale Score to Week 12 | Lytera 2.0 | Baseline | 2.1 | Standard Deviation 0.3 | score on a scale |
| Change From Baseline in Melasma Severity Rating Scale Score to Week 12 | 4% Hydroquinone Topical Cream | Baseline | 2.1 | Standard Deviation 0.3 | score on a scale |
| Change From Baseline in Melasma Severity Rating Scale Score to Week 12 | Lytera 2.0 | Change from Baseline to Week 12 | -0.3 | Standard Deviation 0.4 | score on a scale |
| Change From Baseline in Melasma Severity Rating Scale Score to Week 12 | 4% Hydroquinone Topical Cream | Change from Baseline to Week 12 | -0.8 | Standard Deviation 0.7 | score on a scale |
| Change From Baseline in Overall Hyperpigmentation Scale Score to Week 12 | Lytera 2.0 | Baseline | 4.8 | Standard Deviation 1.1 | score on a scale |
| Change From Baseline in Overall Hyperpigmentation Scale Score to Week 12 | 4% Hydroquinone Topical Cream | Baseline | 4.8 | Standard Deviation 1.1 | score on a scale |
| Change From Baseline in Overall Hyperpigmentation Scale Score to Week 12 | Lytera 2.0 | Change from Baseline to Week 12 | -0.8 | Standard Deviation 1.0 | score on a scale |
| Change From Baseline in Overall Hyperpigmentation Scale Score to Week 12 | 4% Hydroquinone Topical Cream | Change from Baseline to Week 12 | -1.7 | Standard Deviation 1.3 | score on a scale |
| Change From Baseline in Melasma Area and Severity Index (MASI) Score to Week 12 | Lytera 2.0 | Baseline | 9.0 | Standard Deviation 3.9 | score on a scale |
| Change From Baseline in Melasma Area and Severity Index (MASI) Score to Week 12 | 4% Hydroquinone Topical Cream | Baseline | 8.9 | Standard Deviation 3.8 | score on a scale |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Left Side Lytera 2.0, Right Side 4% Hydroquinone | 8 | |
| Overall Study | STARTED | Left Side 4% Hydroquinone, Right Side Lytera 2.0 | 10 | |
| Overall Study | COMPLETED | Left Side Lytera 2.0, Right Side 4% Hydroquinone | 6 | |
| Overall Study | COMPLETED | Left Side 4% Hydroquinone, Right Side Lytera 2.0 | 10 | |
| Overall Study | NOT COMPLETED | Left Side Lytera 2.0, Right Side 4% Hydroquinone | 2 | |
| Overall Study | NOT COMPLETED | Left Side 4% Hydroquinone, Right Side Lytera 2.0 | 0 |
Source ClinicalTrials.gov
Adverse events28
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | Left Side Lytera 2.0, Right Side 4% Hydroquinone | 1 | 8 | |
| other | Nasopharyngitis | Infections and infestations | Left Side 4% Hydroquinone, Right Side Lytera 2.0 | 0 | 10 | |
| other | Lip blister | Gastrointestinal disorders | Left Side Lytera 2.0, Right Side 4% Hydroquinone | 1 | 8 | |
| other | Lip blister | Gastrointestinal disorders | Left Side 4% Hydroquinone, Right Side Lytera 2.0 | 0 | 10 | |
| other | Influenza | Infections and infestations | Left Side Lytera 2.0, Right Side 4% Hydroquinone | 2 | 8 | |
| other | Influenza | Infections and infestations | Left Side 4% Hydroquinone, Right Side Lytera 2.0 | 0 | 10 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Left Side Lytera 2.0, Right Side 4% Hydroquinone | 1 | 8 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Left Side 4% Hydroquinone, Right Side Lytera 2.0 | 0 | 10 | |
| other | Crohn's disease | Gastrointestinal disorders | Left Side Lytera 2.0, Right Side 4% Hydroquinone | 1 | 8 | |
| other | Crohn's disease | Gastrointestinal disorders | Left Side 4% Hydroquinone, Right Side Lytera 2.0 | 0 | 10 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Left Side Lytera 2.0, Right Side 4% Hydroquinone | 0 | 8 |
| Total, all-cause mortality | Left Side 4% Hydroquinone, Right Side Lytera 2.0 | 0 | 10 |
| Total, other adverse events | Left Side Lytera 2.0, Right Side 4% Hydroquinone | 5 | 8 |
| Total, other adverse events | Left Side 4% Hydroquinone, Right Side Lytera 2.0 | 4 | 10 |
| Total, serious adverse events | Left Side Lytera 2.0, Right Side 4% Hydroquinone | 1 | 8 |
| Total, serious adverse events | Left Side 4% Hydroquinone, Right Side Lytera 2.0 | 0 | 10 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Left Side Lytera 2.0, Right Side 4% Hydroquinone vs Left Side 4% Hydroquinone, Right Side Lytera 2.0: deaths from any cause | Trial comparisons |
| Left Side Lytera 2.0, Right Side 4% Hydroquinone vs Left Side 4% Hydroquinone, Right Side Lytera 2.0: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02977507
GET https://conductscience.org/api/trials/v1/NCT02977507/results?page=2