Trial · NCT03075891
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Inflammatory Lesion Count at Week 12 | Baseline, Week 12 | Percent change from baseline in inflammatory lesion count at week 12 was reported. Inflammatory lesions included facial inflammatory lesions of rosacea (that is \[i.e.\] papules and pustules) which were defined as follows: Papule - a small, solid elevation less than 1.0 centimeter (cm) in diameter; and Pustule - a small, circumscribed elevation of the skin, which contains yellow white exudates. Papules and pustules were counted separately on each of the 5 facial regions (forehead, chin, nose, right cheek and left cheek). Notably, nodules (i.e. circumscribed, elevated, solid lesions more than 1.0 cm in diameter with palpable depth) were not included in the count of inflammatory lesions. |
| Secondary | Percent Change From Baseline in Inflammatory Lesion Count at Weeks 4 and 8 | Baseline, Weeks 4 and 8 | Percent change from baseline in inflammatory lesion count at Weeks 4 and 8 was reported. Inflammatory lesions included facial inflammatory lesions of rosacea (i.e. papules and pustules) which were defined as follows: Papule - a small, solid elevation less than 1.0 centimeter in diameter. Pustule - a small, circumscribed elevation of the skin, which contains yellow white exudates. Papules and pustules were counted separately on each of the 5 facial regions (forehead, chin, nose, right cheek and left cheek). Notably, nodules (i.e. circumscribed, elevated, solid lesions more than 1.0 cm in diameter with palpable depth) were not included in the count of inflammatory lesions. |
| Secondary | Percentage of Participants With Clear Inflammatory Lesions at Week 12 | Week 12 | Percentage of participants with clear inflammatory lesions at week 12 was reported. Inflammatory lesions included facial inflammatory lesions of rosacea (i.e. papules and pustules) which were defined as follows: Papule - a small, solid elevation less than 1.0 cm in diameter. Pustule - a small, circumscribed elevation of the skin, which contains yellow white exudates. Papules and pustules were counted separately on each of the 5 facial regions (forehead, chin, nose, right cheek and left cheek). Notably, nodules (i.e. circumscribed, elevated, solid lesions more than 1.0 cm in diameter with palpable depth) were not included in the count of inflammatory lesions. |
| Secondary | Percentage of Participants With 100 Percent (%) Reduction in Inflammatory Lesions at Weeks 4, 8 and 12 | Weeks 4, 8 and 12 | Percentage of participants with 100% reduction in inflammatory lesions at Weeks 4, 8 and 12 was reported. Inflammatory lesions included facial inflammatory lesions of rosacea (i.e. papules and pustules) which were defined as follows: Papule - a small, solid elevation less than 1.0 centimeter in diameter. Pustule - a small, circumscribed elevation of the skin, which contains yellow white exudates. Papules and pustules were counted separately on each of the 5 facial regions (forehead, chin, nose, right cheek and left cheek). Notably, nodules (i.e. circumscribed, elevated, solid lesions more than 1.0 cm in diameter with palpable depth) were not included in the count of inflammatory lesions. |
| Secondary | Clinician's Erythema Assessment (CEA) Total Score at Weeks 4, 8 and 12 | Weeks 4, 8 and 12 | The evaluator assessed the participant's diffuse persistent facial erythema of rosacea by performing a static ("snap shot") evaluation of erythema severity at a social distance of approximately 50 centimeter (cm) using CEA scale, at each visit. CEA is a 5 point scale where 0 = clear (clear skin with no signs of erythema); 1 = almost clear (almost clear; slight redness); 2 = mild (mild erythema; definite redness); 3 = moderate (moderate erythema; marked redness); 4 = severe (severe erythema; fiery redness). A higher score than baseline indicates a worse outcome. |
| Secondary | Percentage of Participants in Each Clinician's Erythema Assessment Score Category at Weeks 4, 8 and 12 | Weeks 4, 8 and 12 | The evaluator assessed the participant's diffuse persistent facial erythema of rosacea by performing a static ("snap shot") evaluation of erythema severity at a social distance of approximately 50 centimeter (cm) using CEA scale, at each visit. CEA is a 5 point scale where 0 = clear (clear skin with no signs of erythema); 1 = almost clear (almost clear; slight redness); 2 = mild (mild erythema; definite redness); 3 = moderate (moderate erythema; marked redness); 4 = severe (severe erythema; fiery redness). A higher score than baseline indicates a worse outcome. |
| Secondary | Investigator's Global Assessment (IGA) Total Score at Weeks 4, 8 and 12 | Weeks 4, 8 and 12 | The evaluator assessed the participant's rosacea by performing a static ("snap shot") evaluation, at a social distance of approximately 50 cm, using the IGA score. IGA is a 5 point scale where, 0 = clear (no inflammatory lesions present, no erythema); 1 = almost clear (very small papules/pustules, very mild erythema present); 2 = mild (few small papules/pustules, mild erythema); 3 = moderate (severe small or large papules/pustules, moderate erythema); 4 = severe (numerous small and/or large papules/pustules, severe erythema). |
| Secondary | Percentage of Participants in Each Investigator's Global Assessment Score Category at Weeks 4, 8 and 12 | Weeks 4, 8 and 12 | The evaluator assessed the participant's rosacea by performing a static ("snap shot") evaluation, at a social distance of approximately 50 cm, using the IGA score. IGA is a 5 point scale where, 0 = clear (no inflammatory lesions present, no erythema); 1 = almost clear (very small papules/pustules, very mild erythema present); 2 = mild (few small papules/pustules, mild erythema); 3 = moderate (severe small or large papules/pustules, moderate erythema); 4 = severe (numerous small and/or large papules/pustules, severe erythema). |
| Secondary | Stinging/Burning Severity Score at Weeks 4, 8 and 12 | Weeks 4, 8 and 12 | The evaluator recorded the severity of the participant's facial stinging/burning sensation during the last 24 hours according to the stinging/burning scale. Stinging/burning scale is a 4 point scale where, 0 = none (No stinging/burning ); 1 = mild (slight warm, tingling/stinging sensation, not really bothersome); 2 = moderate (definite warm, tingling/stinging sensation that is somewhat bothersome); 3 = severe (hot, tingling/stinging sensation that has caused definite discomfort). |
| Secondary | Percentage of Participants in Each Stinging/Burning Severity Score Category at Weeks 4, 8 and 12 | Weeks 4, 8 and 12 | The evaluator recorded the severity of the participant's facial stinging/burning sensation during the last 24 hours according to the stinging/burning scale. Stinging/burning scale is a 4 point scale where, 0 = none (No stinging/burning ); 1 = mild (slight warm, tingling/stinging sensation, not really bothersome); 2 = moderate (definite warm, tingling/stinging sensation that is somewhat bothersome); 3 = severe (hot, tingling/stinging sensation that has caused definite discomfort). |
| Secondary | Global Improvement Total Score at Week 12 (Last Visit/Early Termination) | Week 12 (last visit/early termination) | Participants were evaluated for his/her improvement in rosacea compared to his/her rosacea condition before study, using global Improvement scale. It is a 7 item scale where, 0=complete improvement (all signs and symptoms of disease have resolved \[100% improvement\]); 1=excellent improvement (nearly all signs and symptoms cleared \[90% improvement\]. Only minimal residual signs and symptoms remain); 2=very good improvement (majority of the signs and symptoms have resolved \[about 75% improvement\]); 3=good improvement (significant improvement, but many signs and symptoms remain \[about 50% improvement\]); 4=minimal improvement (slight overall improvement, but not clinically significant \[about 25% improvement\]); 5=no change (overall severity similar to baseline); 6=worse (worse than baseline). |
| Secondary | Percentage of Participants in Each Global Improvement Score Category at Week 12 (Last Visit/Early Termination) | Week 12 (last visit/early termination) | Participants were to evaluated for his/her improvement in rosacea compared to his/her rosacea condition before study, using global Improvement scale. it is a 7 item scale where, 0=complete improvement (all signs and symptoms of disease have resolved \[100% improvement\]); 1=excellent improvement (nearly all signs and symptoms cleared \[90% improvement\]. Only minimal residual signs and symptoms remain); 2=very good improvement (majority of the signs and symptoms have resolved \[about 75% improvement\]); 3=good improvement (significant improvement, but many signs and symptoms remain \[about 50% improvement\]); 4=minimal improvement (slight overall improvement, but not clinically significant \[about 25% improvement\]); 5=no change (overall severity similar to baseline); 6=worse (worse than baseline). . |
| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From the signing of the informed consent form (ICF) up to Week 12 | An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily had a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A SAE was any untoward medical occurrence that at any dose: results in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. |
| Secondary | Dermatology Life Quality Index (DLQI) Questionnaire Total Score at Week 12 (Last Visit/Early Termination Visit) | Week 12 (last visit/early termination) | DLQI focuses on impact of dermatological diseases on quality of life. It is a 10-item validated quality-of-life questionnaire specific to dermatological conditions. 1) how itchy, sore, painful, stinging?, 2) how embarrassed/self-conscious?, 3) interfere shopping or looking after home or garden?, 4) Influence clothes?, 5) affect social/leisure activity?, 6) difficult to do sport?, 7) prevent from working/studying? or If no, problem at work/studying?, 8) problem with partner or close friend?, 9) cause sexual difficulties?, 10) problem caused by treatment?. Total score ranged from 0-30 (each question had a score range of 0- 3) where, 0-1=no effect at all on life; 2-5=small effect on life; 6-10=moderate effect on life; 11- 20=very large effect on life; 21-30=extremely large effect on life. A higher score indicates a low quality of life due to more severe disease. |
| Secondary | Percentage of Participants in Each Dermatology Life Quality Index (DLQI) Questionnaire Score Category | Baseline, Week 12 (last visit/early termination) | Impact of study treatments on subjects' quality of life was measured by using DLQI questionnaire. DLQI focuses on impact of dermatological diseases on quality of life. It is a 10-item validated quality-of-life questionnaire specific to dermatological conditions. 1) how itchy, sore, painful, stinging?, 2) how embarrassed/self-conscious?, 3) interfere shopping or looking after home or garden?, 4) Influence clothes?, 5) affect social/leisure activity?, 6) difficult to do sport?, 7) prevent from working/studying? or If no, problem at work/studying?, 8) problem with partner or close friend?, 9) cause sexual difficulties?, 10) problem caused by treatment?. Total score ranged from 0-30 (each question had a score range of 0- 3) where, 0-1=no effect at all on life; 2-5=small effect on life; 6-10=moderate effect on life; 11- 20=very large effect on life; 21-30=extremely large effect on life. A higher score indicates a low quality of life due to more severe disease. |
| Secondary | Percent Change From Baseline in Dermatology Life Quality Index Questionnaire Total Score at Week 12 (Last Visit/Early Termination) | Baseline, Week 12 (last visit/early termination) | Percent Change from Baseline in Dermatology Life Quality Index questionnaire Total Score at Last Visit. DLQI focuses on impact of dermatological diseases on quality of life. It is a 10-item validated quality-of life questionnaire specific to dermatological conditions. 1) how itchy, sore, painful, stinging?, 2) how embarrassed/self-conscious?, 3) interfere shopping or looking after home or garden?, 4) Influence clothes?, 5) affect social/leisure activity?, 6) difficult to do sport?, 7) prevent from working/studying? or If no, problem at work/studying?, 8) problem with partner or close friend?, 9) cause sexual difficulties?, 10) problem caused by treatment?. Total score ranged from 0-30 (each question had a score range of 0-3) where, 0-1=no effect at all on life; 2-5=small effect on life; 6-10=moderate effect on life; 11- 20=very large effect on life; 21-30=extremely large effect on life. A higher score indicates a low quality of life due to more severe disease. |
| Secondary | EuroQol-5 Dimension-5 Level (EQ-5D-5L) Questionnaire at Week 12 (Last Visit/Early Termination Visit) | Week 12/Last visit or early termination visit | EQ-5D-5L is a 5-level, 5-dimensional format standardized instrument for use as a measure of health outcome used to assess the impact of study treatments on participants quality of life as follows: 1) mobility; 2) self-care; 3) usual activities; 4) pain/discomfort; 5) anxiety/depression. Each dimension comprised of 5 levels with corresponding numeric scores, where 1 indicated no problems, and 5 indicated extreme problems. Participant selected answer for each of 5 dimensions considering response that best matches his/her health today with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). An increase in the EQ-5D-5L total score indicates improvement. |
| Secondary | Percentage of Participants in Each EuroQol-5 Dimension-5 Level Questionnaire Questions Who Reported No Problems at Baseline and Week 12 (Last Visit/Early Termination) | Baseline, Week 12 (last visit/early termination) | EQ-5D-5L is a 5-level, 5-dimensional format standardized instrument for use as a measure of health outcome used to assess the impact of study treatments on participants quality of life as follows: 1) mobility; 2) self-care; 3) usual activities; 4) pain/discomfort; 5) anxiety/depression. Each dimension comprised of 5 levels with corresponding numeric scores, where 1 indicated no problems, and 5 indicated extreme problems. Participant selected answer for each of 5 dimensions considering response that best matches his/her health today with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). An increase in the EQ-5D-5L total score indicates improvement. |
| Secondary | Percentage of Participants Reported Work Productivity and Activity Impairment: General Health (WPAI:GH) Questionnaire for Currently Employed Question at Week 12 (Last Visit/Early Termination Visit) | Week 12 (Last visit/early termination visit) | WPAI:GH questionnaire was an instrument to measure impairments in both paid work and unpaid work. It measures absenteeism, presenteeism as well as the impairments in unpaid activity because of health problem during the past seven days. Low scores indicate little or no impact of health problems on work and activities, and a negative change in the WPAI score indicates improvement. Currently Employed question was assessed in this outcome measure. |
| Secondary | Work Productivity and Activity Impairment: General Health (WPAI:GH) Questionnaire - Hours Missed at Work, Impact to Productivity at Work and Daily Activities at Week 12 | Week 12 (Last visit/Early termination visit) | WPAI:GH questionnaire is an instrument to measure impairment in both paid and unpaid work during the past week including questions: missed hours from work because of rosacea?, missed hours from work because of other reason?, number of Working hours. It measures absenteeism, presenteeism as well as the impairments in unpaid activity because of health problem during the past seven days. Low scores indicate little or no impact of health problems on work and activities, and a negative change in the WPAI score indicates improvement. |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03075891/registered