Trial · NCT02561585
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Severity of Alopecia Areata Tool (SALT) Score | From baseline (Day 1) to Week 12 (Day 84) | The SALT score indicates the sum area of scalp with hair loss and ranges from 0 - 100 (min-max), with higher scores indicating more hair loss. A negative change in SALT score indicates lesser (improvement) hair loss while positive high scores indicate more (worsening) hair loss. |
| Secondary | Summary of Absolute SALT Score | At baseline (Day 1), Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) | The SALT (Severity of Alopecia Areata Tool) score indicates the sum area of scalp with hair loss and ranges from 0 - 100 (min-max), with higher scores indicating more hair loss. Summary of observed values of the absolute SALT score. |
| Secondary | Summary of Change in SALT Score | From baseline (Day 1) to Week 4 (Day 28), Week 8 (Day 56), and Week 12 (Day 84) | The SALT (Severity of Alopecia Areata Tool) score indicates the sum area of scalp with hair loss and ranges from 0 - 100 (min-max), with higher scores indicating more hair loss. A negative change in SALT score indicates lesser (improvement) hair loss while positive high scores indicate more (worsening) hair loss. |
| Secondary | Summary of Relative Change in SALT Score | From baseline (Day 1) to Week 4 (Day 28), Week 8 (Day 56), and Week 12 (Day 84) | The SALT (Severity of Alopecia Areata Tool) score indicates the sum area of scalp with hair loss and ranges from 0 - 100 (min-max), with higher scores indicating more hair loss. A negative change in SALT score indicates lesser (improvement) hair loss while positive high scores indicate more (worsening) hair loss. |
| Secondary | Percentage of Patients Who Achieve 50% Improvement in the SALT Score | At Week 12 (Day 84) | The event of having at least 50% reduction in SALT score at Week 12 (Day 84) as compared to baseline (Day 1) |
| Secondary | Hair Length | At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) | Hair length measured in millimeters. |
| Secondary | Hair Growth Rate | At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) | Change in hair length measured in millimeters per day. |
| Secondary | Relative Hair Thickness | At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) | Thickness relative to participant's normal scalp hair. Relative assessment not applicable for participants with alopecia areata totalis and universalis. |
| Secondary | Hair Type | At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) | Hair type being either vellus hair or terminal hair. Hair type is not applicable for participants with alopecia areata totalis and universalis. |
| Secondary | Hair Color | At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) | Absolute color of hair. Hair color is not applicable for alopecia areata totalis and universalis. |
| Secondary | Global Assessment of Overall Hair Regrowth Compared to Baseline | At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) | Based on standardized photographs |
| Secondary | Participant's Global Assessment of Hair Regrowth | At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) | The participant will assess the hair regrowth before the investigator does any assessments of hair regrowth. |
| Secondary | Subcategory and Total Score of the Alopecia Areata Quality of Life Questionnaire (AA-QLI) | At baseline (Day 1) and at Week 12 (Day 84) | The scale includes 21 questions measuring the degree to which the patient was affected by the AA in the last month, scored from 1 (not affected at all) to 4 (highly affected). The AA-QLI transformed scores for each of the subcategories 'subjective symptoms', 'relationship' and 'objective signs' ranging from (min-max) 9-36, 9-36, and 3-12. Total score ranges from 0-84. Low score indicating that the participant was least affected by AA. |
| Secondary | Treatment Satisfaction Questionnaire for Medication Score | At Week 12 (Day 84) | The Treatment Satisfaction Questionnaire for Medication (TSQM II) is a validated, general measure of treatment satisfaction for medication - accounting for effectiveness, side effects, convenience, and global satisfaction - that is comparable across medication types and patient conditions. The individual derived score for each of the 4 dimensions (effectiveness, side effects, convenience, and global satisfaction) of the TSQM II questionnaire ranged from 0-100, with a higher score indicating greater satisfaction to treatment. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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