Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To assess the efficacy, safety and pharmacokinetics in participants treated with CD11301 gel vs. placebo for early stage CTCL (IA, IB, or IIA).
To assess the efficacy and safety of two concentrations (0.03% and 0.06%) of CD11301 gel in the treatment of early stage CTCL (stage IA, IB, or IIA) versus placebo.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD11301 Gel 0.06% | Experimental | Participants applied 0.06% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for cycle 1 and 2 i.e. 24 weeks. |
|
| CD11301 Gel 0.03% | Experimental | Participants applied 0.03% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for cycle 1 and 2 i.e. 24 weeks. |
|
| Placebo | Experimental | Participants applied placebo gel during cycle one followed by 0.03% CD11301 gel topically during cycle two once daily, 3 to 5 times per week, for 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Non active ingredients of CD11301 |
| |
| CD11301 0.03% |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reported Overall Response (Complete and Partial) of Target Treated Lesions Based on Modified Composite Assessment of Index Lesion Severity (mCAILS) Score at Week 12 | Overall response is defined as the number of participants that achieved a complete response (CR) or partial response (PR) as assessed by mCAILS. The mCAILS assessment total was derived from components collected on the case report form (CRF). Target treated lesions (1-5 lesions) were rated in erythema (0-8, where 0=no evidence and 8= very severe), scaling (0-8, where 0=no evidence and 8= very severe), plaque elevation (0-3, where 0=no evidence and 3= marked elevation), and size (scale=0-18, where 0= no measurable area and 18= size of lesion >300 centimeter [cm]^2). These 4 ratings were summed to create subtotals, 1 per lesion. The final mCAILS assessment score was the sum of these subtotals. Total summation Score: 0-50 where higher score indicated higher severity. Complete response is defined as a 100% decrease from baseline i.e. score of '0' on the mCAILS scale. Partial response is defined as at least a 50%, but less than 100%, decrease from baseline. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reported Overall Response (OR) of Target Treated Lesions Based on Modified Severity-Weighted Assessment Tool (mSWAT) Score at Week 12 | OR is defined as the number of participants that achieved a complete response or partial response as assessed by mSWAT. mSWAT composite score involved the direct assessment of the BSA of each type of lesion (palm plus fingers of the participant= approximately 1% BSA) in each of 12 areas (Head, Neck, Anterior trunk, Arms, Forearms, Hands, Posterior trunk, Buttocks, Thighs, Legs, Feet, Groin) of the body, multiplying the sum of the BSA of each lesion type by a weighting factor (patch = 1, plaque = 2, and tumor = 3 or 4) and generating a sum of the subtotals of each lesion subtype. mSWAT score (0=no lesions; 400= lesions covering all areas). Complete response is defined as a 100% decrease from baseline. Partial response is defined as at least a 50%, but less than 100%, decrease from baseline, and with a tumor subscore of zero (no tumor). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Galderma R&D | Galderma R&D | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Investigational Site | Orange | California | 92868 | United States | ||
| Galderma Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32632956 | Derived | Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3. |
Not provided
Not provided
No intent to share information.
Not provided
Not provided
Not provided
Not provided
This study consisted of 2 cycles: Cycle 1 and Cycle 2. Each treatment cycle consisted of 8 weeks on treatment followed by 4 weeks without treatment. Cycle 1: drug product was applied on up to 5 percent (%) body surface area (BSA) and 10% BSA in cycle 2.
This study was conducted at 3 countries (France, Germany, USA) between 19 Dec 2017 to 17 Mar 2020. A total of 86 participants were randomized to 1 of the 3 treatment groups (placebo gel or CD11301 gel 0.03% or 0.06%) in a 1:1:1 ratio.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | CD11301 Gel 0.06% | Participants applied 0.06% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for cycle 1 and 2 i.e. 24 weeks. |
| FG001 | CD11301 Gel 0.03% |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 25, 2019 | Mar 10, 2021 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Topical Gel |
|
| CD11301 0.06% | Drug | Topical Gel |
|
| Week 12 |
| Time to Participant's First Overall Response (Complete or Partial) of the Target Treated Lesions Based on the mCAILS Score | Time to overall response (CR or PR) is the number of days from the start of drug application to the first documentation of objective response assessed by mCAILS Score. The 25th, 50th, and 75th percentiles were presented along with 95% confidence intervals using the log-log transformation. The mCAILS assessment total was derived from components collected on the case report form (CRF). Target treated lesions (1-5 lesions) were rated in erythema (0-8, where 0=no evidence and 8= very severe), scaling (0-8, where 0=no evidence and 8= very severe), plaque elevation (0-3, where 0=no evidence and 3= marked elevation), and size (scale=0-18, where 0= no measurable area and 18= size of lesion >300 centimeter [cm]^2). These 4 ratings were summed to create subtotals, 1 per lesion. The final mCAILS assessment score was the sum of these subtotals. Total summation Score: 0-50 where higher score indicated higher severity. | Up to Week 36 |
| Duration of Overall Response (Complete Response or Partial Response) Based on mCAILS Score | The duration of overall response (complete or partial) of the target treated lesions based on the mCAILS score was calculated in days as: (date of first non-response after responding) - (date of response) + 1. The mCAILS assessment total was derived from components collected on the case report form (CRF). Target treated lesions (1-5 lesions) were rated in erythema (0-8, where 0=no evidence and 8= very severe), scaling (0-8, where 0=no evidence and 8= very severe), plaque elevation (0-3, where 0=no evidence and 3= marked elevation), and size (scale=0-18, where 0= no measurable area and 18= size of lesion >300 centimeter [cm]^2). These 4 ratings were summed to create subtotals, 1 per lesion. The final mCAILS assessment score was the sum of these subtotals. Total summation Score: 0-50 where higher score indicated higher severity. | Up to Week 36 |
| Time to Progressive Disease Using mSWAT | Progressive disease is defined as ≥ 25% increase in skin disease from baseline, or loss of response: in those with CR or PR, increase of skin score of greater than the sum of nadir plus 50% baseline score, Nadir is defined as the lowest skin score (best response). | Up to Week 36 |
| Change From Baseline in Skindex-29 Survey Results at Week 12, 24 and 36 | Participants answered 30 questions as part of the Skindex-29 survey. A composite score and 3 sub scores were calculated from the results. Item 18 of the survey was not used in any scoring. First, answers to each item were given a numeric value: Never = 0; Rarely = 25; Sometimes = 50; Often = 75; All the time = 100. The items used to calculate each subscore were: Emotions: 3, 6, 9, 12, 13, 15, 21, 23, 26, and 28 (10 items), Symptoms: 1, 7, 10, 16, 19, 24, and 27 (7 items), Functioning: 2, 4, 5, 8, 11, 14, 17, 20, 22, 25, 29, and 30 (12 items). The composite score is the average of the 3 sub scores ranging from 0 (no effect)-100 (maximum effect), higher score corresponds to lower quality of life. | Week 12, 24 and Follow up (Week 36) |
| Palo Alto |
| California |
| 94304 |
| United States |
| Galderma Investigational Site | Farmington | Connecticut | 06032 | United States |
| Galderma Investigational Site | Chicago | Illinois | 60611 | United States |
| Galderma Investigational Site | Boston | Massachusetts | 02115 | United States |
| Galderma Investigational Site | Durham | North Carolina | 27710 | United States |
| Galderma Investigational Site | Philadelphia | Pennsylvania | 19104 | United States |
| Galderma Investigational Site | Philadelphia | Pennsylvania | 19107 | United States |
| Galderma Investigational Site | Pittsburgh | Pennsylvania | 15213 | United States |
| Galderma Investigational Site | Dallas | Texas | 75231 | United States |
| Galderma Investigational Site | Houston | Texas | 77030 | United States |
| Galderma Investigational Site | Pierre-Bénite | Auvergne-Rhône-Alpes | 69310 | France |
| Galderma Investigational Site | Nantes | Pays de la Loire Region | 44093 | France |
| Galderma Investigational Site | Paris | Île-de-France Region | 75010 | France |
| Galderma Investigational Site | Mannheim | Baden-Wurttemberg | 68167 | Germany |
| Galderma Investigational Site | Würzburg | Bavaria | 97080 | Germany |
| Galderma Investigational Site | Krefeld | North Rhine-Westphalia | 47805 | Germany |
| Galderma Investigational Site | Minden | North Rhine-Westphalia | 32429 | Germany |
| Galderma Investigational Site | Münster | North Rhine-Westphalia | 48149 | Germany |
| Galderma Investigational Site | Kiel | Schleswig-Holstein | 24105 | Germany |
| Galderma Investigational Site | Berlin | 10117 | Germany |
Participants applied 0.03% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for cycle 1 and 2 i.e. 24 weeks.
| FG002 | Placebo | Participants applied placebo gel during cycle one followed by 0.03% CD11301 gel topically during cycle two once daily, 3 to 5 times per week, for 24 weeks. |
|
| Participants Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent to treat (ITT) Population included all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | CD11301 Gel 0.06% | Participants applied 0.06% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for cycle 1 and 2 i.e. 24 weeks. |
| BG001 | CD11301 Gel 0.03% | Participants applied 0.03% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for cycle 1 and 2 i.e. 24 weeks. |
| BG002 | Placebo | Participants applied placebo gel during cycle one followed by 0.03% CD11301 gel topically during cycle two once daily, 3 to 5 times per week, for 24 weeks. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Reported Overall Response (Complete and Partial) of Target Treated Lesions Based on Modified Composite Assessment of Index Lesion Severity (mCAILS) Score at Week 12 | Overall response is defined as the number of participants that achieved a complete response (CR) or partial response (PR) as assessed by mCAILS. The mCAILS assessment total was derived from components collected on the case report form (CRF). Target treated lesions (1-5 lesions) were rated in erythema (0-8, where 0=no evidence and 8= very severe), scaling (0-8, where 0=no evidence and 8= very severe), plaque elevation (0-3, where 0=no evidence and 3= marked elevation), and size (scale=0-18, where 0= no measurable area and 18= size of lesion >300 centimeter [cm]^2). These 4 ratings were summed to create subtotals, 1 per lesion. The final mCAILS assessment score was the sum of these subtotals. Total summation Score: 0-50 where higher score indicated higher severity. Complete response is defined as a 100% decrease from baseline i.e. score of '0' on the mCAILS scale. Partial response is defined as at least a 50%, but less than 100%, decrease from baseline. | ITT Population included all randomized participants. Here, overall number of participants analyzed signifies number of participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | Week 12 |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Reported Overall Response (OR) of Target Treated Lesions Based on Modified Severity-Weighted Assessment Tool (mSWAT) Score at Week 12 | OR is defined as the number of participants that achieved a complete response or partial response as assessed by mSWAT. mSWAT composite score involved the direct assessment of the BSA of each type of lesion (palm plus fingers of the participant= approximately 1% BSA) in each of 12 areas (Head, Neck, Anterior trunk, Arms, Forearms, Hands, Posterior trunk, Buttocks, Thighs, Legs, Feet, Groin) of the body, multiplying the sum of the BSA of each lesion type by a weighting factor (patch = 1, plaque = 2, and tumor = 3 or 4) and generating a sum of the subtotals of each lesion subtype. mSWAT score (0=no lesions; 400= lesions covering all areas). Complete response is defined as a 100% decrease from baseline. Partial response is defined as at least a 50%, but less than 100%, decrease from baseline, and with a tumor subscore of zero (no tumor). | ITT Population included all randomized participants. Here, overall number of participants analyzed signifies number of participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | Week 12 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Time to Participant's First Overall Response (Complete or Partial) of the Target Treated Lesions Based on the mCAILS Score | Time to overall response (CR or PR) is the number of days from the start of drug application to the first documentation of objective response assessed by mCAILS Score. The 25th, 50th, and 75th percentiles were presented along with 95% confidence intervals using the log-log transformation. The mCAILS assessment total was derived from components collected on the case report form (CRF). Target treated lesions (1-5 lesions) were rated in erythema (0-8, where 0=no evidence and 8= very severe), scaling (0-8, where 0=no evidence and 8= very severe), plaque elevation (0-3, where 0=no evidence and 3= marked elevation), and size (scale=0-18, where 0= no measurable area and 18= size of lesion >300 centimeter [cm]^2). These 4 ratings were summed to create subtotals, 1 per lesion. The final mCAILS assessment score was the sum of these subtotals. Total summation Score: 0-50 where higher score indicated higher severity. | ITT Population included all randomized participants. Here, overall number of participants analyzed signifies number of participants who were evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Days | Up to Week 36 |
| |||||||||||||||||||||||||||||||||||
| Secondary | Duration of Overall Response (Complete Response or Partial Response) Based on mCAILS Score | The duration of overall response (complete or partial) of the target treated lesions based on the mCAILS score was calculated in days as: (date of first non-response after responding) - (date of response) + 1. The mCAILS assessment total was derived from components collected on the case report form (CRF). Target treated lesions (1-5 lesions) were rated in erythema (0-8, where 0=no evidence and 8= very severe), scaling (0-8, where 0=no evidence and 8= very severe), plaque elevation (0-3, where 0=no evidence and 3= marked elevation), and size (scale=0-18, where 0= no measurable area and 18= size of lesion >300 centimeter [cm]^2). These 4 ratings were summed to create subtotals, 1 per lesion. The final mCAILS assessment score was the sum of these subtotals. Total summation Score: 0-50 where higher score indicated higher severity. | ITT Population included all randomized participants. Here, overall number of participants analyzed signifies number of participants who were evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Days | Up to Week 36 |
| |||||||||||||||||||||||||||||||||||
| Secondary | Time to Progressive Disease Using mSWAT | Progressive disease is defined as ≥ 25% increase in skin disease from baseline, or loss of response: in those with CR or PR, increase of skin score of greater than the sum of nadir plus 50% baseline score, Nadir is defined as the lowest skin score (best response). | ITT Population included all randomized participants. Here, overall number of participants analyzed signifies number of participants who were evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Days | Up to Week 36 |
| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Skindex-29 Survey Results at Week 12, 24 and 36 | Participants answered 30 questions as part of the Skindex-29 survey. A composite score and 3 sub scores were calculated from the results. Item 18 of the survey was not used in any scoring. First, answers to each item were given a numeric value: Never = 0; Rarely = 25; Sometimes = 50; Often = 75; All the time = 100. The items used to calculate each subscore were: Emotions: 3, 6, 9, 12, 13, 15, 21, 23, 26, and 28 (10 items), Symptoms: 1, 7, 10, 16, 19, 24, and 27 (7 items), Functioning: 2, 4, 5, 8, 11, 14, 17, 20, 22, 25, 29, and 30 (12 items). The composite score is the average of the 3 sub scores ranging from 0 (no effect)-100 (maximum effect), higher score corresponds to lower quality of life. | ITT Population included all randomized participants. Here, overall number of participants analyzed signifies number of participants who were evaluable for this outcome measure and at specific category. | Posted | Mean | Standard Deviation | score on scale | Week 12, 24 and Follow up (Week 36) |
|
From start of the study drug administration up to end of the study (Week 72).
Analysis was performed on safety population: randomized participants who applied the study medication at least once.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CD11301 Gel 0.06% | Participants applied 0.06% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for cycle 1 and 2 i.e. 24 weeks. | 0 | 30 | 2 | 30 | 30 | 30 |
| EG001 | CD11301 Gel 0.03% | Participants applied 0.03% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for cycle 1 and 2 i.e. 24 weeks. | 0 | 28 | 2 | 28 | 28 | 28 |
| EG002 | Placebo | Participants applied placebo gel during cycle one followed by 0.03% CD11301 gel topically during cycle two once daily, 3 to 5 times per week, for 24 weeks. | 1 | 27 | 1 | 27 | 27 | 27 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Papillary cystadenoma lymphomatosum | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
| |
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
| |
| Metastases to muscle | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Bundle branch block left | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Atrioventricular block first degree | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Application site erosion | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Application site ulcer | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Application site erythema | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Application site pain | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Application site pruritus | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Application site dermatitis | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Application site rash | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Application site irritation | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Application site eczema | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Application site inflammation | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Urine leukocyte esterase positive | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Mycosis fungoides | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Skin erosion | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Papule | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations | Galderma | 817 961 5000 | 1 | Clinical.Studies@galderma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 23, 2020 | Mar 12, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG002 | Placebo | Participants applied placebo gel during cycle one followed by 0.03% CD11301 gel topically during cycle two once daily, 3 to 5 times per week, for 24 weeks. |
|
|
Participants applied 0.03% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for cycle 1 and 2 i.e. 24 weeks.
| OG002 | Placebo | Participants applied placebo gel during cycle one followed by 0.03% CD11301 gel topically during cycle two once daily, 3 to 5 times per week, for 24 weeks. |
|
|
| OG002 | Placebo | Participants applied placebo gel during cycle one followed by 0.03% CD11301 gel topically during cycle two once daily, 3 to 5 times per week, for 24 weeks. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG002 | Placebo | Participants applied placebo gel during cycle one followed by 0.03% CD11301 gel topically during cycle two once daily, 3 to 5 times per week, for 24 weeks. |
|
|