DELOS: Phase III Study of Idebenone in Duchenne Muscular Dystrophy (DMD)

• Sponsor: Santhera Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01027884
• Collaborator: (none)
• Enrollment: 65
• Locations: 23
• Arms: 2
• Duration (Months): 57
• Patients Per Site: 2.8
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The aim of this Phase III study was to assess the efficacy of idebenone on pulmonary function, motor function, muscle strength and quality of life in patients with DMD. Furthermore, the safety and tolerability of idebenone was assessed.

Condition or Disease	Intervention/Treatment	Phase
Muscular Dystrophy, Duchenne; Ambulatory Care	Drug: Placebo; Drug: Idebenone	Phase 3

Detailed Description

This study was a Phase III, multicenter, randomized, double-blind, placebo-controlled efficacy and safety study. DMD patients (ambulatory and non-ambulatory) at age 10-18 years were enrolled at sites in Europe and North America. Study subjects were randomized in a 1:1 ratio to receive either idebenone (900 mg/day) or placebo 3 times a day with meals for 52 weeks. The primary endpoint was the difference between Catena®/Raxone® and placebo in the change from Baseline to week 52 in Peak Expiratory Flow (PEF as percent predicted, PEF%p, a measure of respiratory muscle strength) as measured by hospital-based spirometry. PEF was also measured by the patient at home using the hand-held ASMA-1 device (secondary endpoint). Other respiratory endpoints included Forced Expiratory Volume in 1 second (as percent predicted, FEV1%p, an additional measure of respiratory muscle strength) and Forced Vital Capacity (as percent predicted, FVC%p, a measure of restrictive lung disease predictive of morbidity and mortality in DMD).

Study Design

• Study Type: Interventional
• Actual Enrollment: 65 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase III Double-Blind, Randomised, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Idebenone in 10-18 Year Old Patients With Duchenne Muscular Dystrophy
• Study Start Date: Jul 1, 2009
• Actual Primary Completion Date: Jan 1, 2014
• Actual Study Completion Date: Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Placebo 900 mg/day	Drug: Placebo; Placebo (900 mg/day) 2 tabl (150 mg each) x 3 times orally with meals
Experimental: Idebenone Idebenone 900 mg/day	Drug: Idebenone; Idebenone (900 mg/day) 2 tabl (150 mg each) x 3 times orally with meals; Other Names: CATENA® RAXONE®

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Percent Predicted Peak Expiratory Flow (PEF) at Week 52 [Baseline and Week 52]

   Change from Baseline in Percent Predicted Peak Expiratory Flow (PEF) at Week 52

Secondary Outcome Measures

1. Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 52 [Baseline and Week 52]

   Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 52

2. Change From Baseline to Week 52 in Muscle Strength [Baseline and Week 52]

   The change from Baseline to Week 52 in muscle strength as measured by Hand-Held Myometry (HHM) was performed following standardized procedures. As almost all patients were non-ambulatory, only analyses of upper limb muscle strength were performed. Results for elbow flexors and for elbow extensors are reported below.The highest value of 3 consecutive measurements with an interval of at least 10 seconds were recorded. The HHM was measured using MicroFET2, a digital hand held muscle tester. The selected unit of measure was Newtons (N).

3. Change From Baseline to Week 52 in Quality of Life Assessed by PedsQL™ Paediatric Quality of Life Inventory [Baseline and Week 52]

   PedsQL Quality of Life Inventory contains paediatric HRQOL measurements: Physical, Emotional,Social and School Functioning. Item Scaling: 5-point Likert scale from 0 (Never) to 4 (Almost always). 3-point scale: 0 (Not at all), 2 (Sometimes) and 4 (A lot) for the Young Child (ages 5-7). Scores are transformed on a scale from 0 to 100 ( 0=100, 1=75, 2=50, 3=25, 4=0) Total Score: Sum of all the items over the number of items answered on all the Scales. The values reported below are overall scores on Paediatric Quality of Life Inventory in Child/Teen Report. These scores were obtained by averaging scores for all the described subscales. The overall scores range between 0-100 with 0 = worst outcome and 100= best outcome

4. Percentage of Patients Reporting Adverse Events [52 Weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 18 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patients 10 - 18 years of age at Baseline.

2. Signed and dated informed consent.

3. Documented diagnosis of DMD or severe dystrophinopathy and clinical features consistent of typical DMD at diagnosis (i.e. documented delayed motor skills and muscle weakness by age 5 years). DMD should be confirmed by mutation analysis in the dystrophin gene or by substantially reduced levels of dystrophin protein (i.e. absent or <5% of normal) on Western blot or immunostain.

4. Ability to provide reliable and reproducible repeat PEF within 15% of the first assessment (i.e. Baseline vs. Screening).

5. Patients assessed by the investigator as willing and able to comply with the requirements of the study, possess the required cognitive abilities and are able to swallow study medication.

Exclusion Criteria:

1. Patients dependent on assisted ventilation at Screening and/or Baseline (defined as non-invasive nocturnal ventilation, daytime non-invasive ventilation or continuous invasive ventilation).

2. Patients with documented DMD-related hypoventilation for which assisted ventilation is needed according to current standard of care guidelines (e.g. FVC< 30%) or is required in the opinion of the Investigator.

3. Patients with a percent predicted PEF > 80% at Baseline.

4. Patients unable to form a mouth seal to allow precise respiratory flow measurements and mouth pressures.

5. Symptomatic heart failure (high probability of death within one year of Baseline) and/or symptomatic ventricular arrhythmias.

6. Participation in the previous Phase II or Phase II Extension study (SNT-II-001 or SNT-II-001-E) for idebenone.

7. Participation in any other therapeutic trial and/or intake of any investigational drug within 90 days prior to Baseline.

8. Use of carnitine, creatine, glutamine, oxatomide, or any herbal medicines within 30 days prior to Baseline.

9. Use of coenzyme Q10 or vitamin E (if taken at a dose of 5 times above the daily physiological requirement) within 30 days prior to Baseline.

10. Any previous use of idebenone.

11. Any concomitant medication with a depressive or stimulating effect on respiration or the respiratory tract.

12. Planned or expected spinal fixation surgery during the study period (as judged by the investigator).

13. Asthma, bronchitis/COPD, bronchiectasis, emphysema, pneumonia or the presence of any other non-DMD respiratory illness that affects PEF.

14. Chronic use of beta-2 agonists or any use of other bronchodilating medication (e.g. inhaled steroids, sympathomimetics, anticholinergics).

Please note: Chronic use if defined as a daily intake for more than 14 days.

1. Moderate or severe hepatic impairment or severe renal impairment.

2. Prior or ongoing medical condition or laboratory abnormality that in the Investigator's opinion could adversely affect the safety of the subject.

Please note: Patients who suffer from a severe, unstable condition including (but not limited to) cancer, auto-immune diseases, haematological diseases, metabolic disorders or immunodeficiencies, and who are at risk of an aggravation unrelated to the study condition, can only be included in the study if accepted in writing by the Sponsor's Medical Monitor.

1. Relevant history of or current drug or alcohol abuse or use of any tobacco/marijuana products/smoking

2. Known individual hypersensitivity to idebenone or to any of the ingredients/excipients of the study medication

3. Systemic glucocorticoid therapy

4. Chronic use of systemic glucocorticoid therapy for DMD related conditions within 12 months of Baseline (the "12 month non-use period")

5. More than 2 rounds of acute systemic glucocorticoid burst therapy (of ≤2 week duration) for non-DMD related conditions within the 12 month non-use period

6. Use of any round of systemic glucocorticoid burst therapy of longer than 2 weeks duration within the 12 month non-use period

7. Use of systemic glucocorticoid burst therapy less than 8 weeks prior to baseline

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California Davis Medical Center	Sacramento	California	United States	95817
2	Children's Hospital Colorado	Aurora	Colorado	United States	80045
3	University of Florida	Gainesville	Florida	United States	32610
4	Carolinas Medical Center, Neurosciences and Spine Institute	Charlotte	North Carolina	United States	28207
5	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104-1771
6	Monroe Carell, Jr. Children's Hospital at Vanderbilt	Nashville	Tennessee	United States	37232
7	University of Texas Southwestern Medical Center	Dallas	Texas	United States	75390-9105
8	Methodist Neurological Institute	Houston	Texas	United States	77030
9	Seattle Children's Hospital	Seattle	Washington	United States	98105
10	Dr. Günther Bernert, Prim. Univ. Doz.	Wien		Austria	1100
11	University Hospitals Leuven- Children Hospital	Leuven		Belgium	B - 3000
12	Hôpital Roger Salengro, CHRU Lille	Lille		France	59037
13	Prof. Thomas Voit , MD, PhD	Paris Cedex 13		France	75651
14	Universitätsklinikum Essen, Zentrum für Kinderheikunde	Essen		Germany	D-45122
15	Universitätsklinik Freiburg Zentrum für Kinderheilkunde und Jugendmedizin	Freiburg		Germany	79106
16	Fondazione IRCCS "Eugenio Medea"	Bosisio Parini, Lecco		Italy	23842
17	Azienda Ospedaliera Niguarda Ca' Granda Centro Clinico Nemo	Milan		Italy	20162,
18	Azienda Ospedaliera Universitaria della Seconda Università degli Studi di Napoli	Napoli		Italy	80138
19	Ass. Prof. Jan Verschuuren , MD, PhD	Leiden	P.O. Box 9600	Netherlands	2300 RC
20	Hospital Universitario 12 de Octubre	Madrid		Spain	28041
21	Hospital Universitario y Politécnico La Fe	Valencia		Spain	46009
22	Prof. Thomas Sejersen, MD, PhD	Stockholm		Sweden	17176
23	CHUV Lausanne Neuropediatrie	Lausanne		Switzerland	1011

Sponsors and Collaborators

• Santhera Pharmaceuticals

Investigators

• Principal Investigator: Prof. Gunnar Buyse, MD, PhD., University Hospitals Leuven, B-3000, Belgium
• Principal Investigator: Dr. Ulrike Schara, MD, PhD, Universitätsklinikum Essen, D-45122 Essen, Germany
• Principal Investigator: Ass. Prof. Jan Verschuuren, MD, PhD, Leiden University Medical Center (LUMC), 2300 RC Leiden, the Netherlands
• Principal Investigator: Dr. Pierre-Yves Jeannet, Médecin Associé, MER, Unité de Neuropédiatrie, CHUV - BH11, 1011 Lausanne-CH, Switzerland
• Principal Investigator: Prof. Thomas Voit, MD, PhD, Université Pierre et Marie curie VI - Institut de Myologie - groupe hospitalier Pitié Salpétrière - 47/83 boulevard de l'hôpital, 75651 Paris Cedex 13, France
• Principal Investigator: Prof. Thomas Sejersen, MD, PhD, Astrid Lindgrens Barnsjukhus- Karolinska Universitetssjukhuset, SE-17176 Stockholm, Sweden
• Principal Investigator: Dr. Günther Bernert, Prim. Univ. Doz., Vorstand der Abteilung für Kinder- und Jugendheilkunde, Gottfried v. Preyer'sches Kinderspital, 1100 Wien, Austria
• Principal Investigator: Gihan Tennekoon, MD, Division of Neurology - The Children's Hospital of Philadelphia - 34th Street and Civic Center Blvd, Philadelphia, PA 19104-1771, USA
• Principal Investigator: Jean-Marie Cuisset, MD, Hôpital Roger Salengro, CHRU, Service de neurologie infantile, Lille, France
• Principal Investigator: Susan Iannaccone, MD, University of Texas Southwestern Medical Center, TX, USA
• Principal Investigator: Susan Sparks, MD, The Charlotte-Mecklenburg Hospital Authority, Charlotte, NC, USA
• Principal Investigator: Janbernd Kirschner, MD, Universitätsklinik Freiburg Zentrum für Kinderheilkunde und Jugendmedizin
• Principal Investigator: Maria Grazia Nadia D'Angelo, MD, Fondazione IRCCS "Eugenio Medea"
• Principal Investigator: Ksenija Gorni, MD, Azienda Ospedaliera Niguarda Ca'Granda Centro Clinico Nemo
• Principal Investigator: Bryan W. Burnette, MD, Monroe Carell Jr. Children's Hospital at Vanderbilt
• Principal Investigator: Barry Byrne, MD, University of Florida
• Principal Investigator: Michele Yang, MD, Children's Hospital Colorado
• Principal Investigator: Susan Apkon, MD, Seattle Children's Hospital
• Principal Investigator: Ericka Simpson, MD, Methodist Neurological Institute, Houston
• Principal Investigator: Craig McDonald, MD, University of California, Davis
• Principal Investigator: Luisa Politano, MD, Azienda Ospedaliera Universitaria della Seconda Università degli Studi di Napoli
• Principal Investigator: Ana Camacho Salas, MD, Hospital Universitario 12 de Octubre
• Principal Investigator: Juan Jesus Vilchez, MD, Hospital Universitari y Politècnic La Fe de Valencia

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Santhera Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01027884
• Other Study ID Numbers: SNT-III-003
• First Posted: Dec 9, 2009
• Last Update Posted: Oct 19, 2015
• Last Verified: Sep 1, 2015

• Keywords provided by Santhera Pharmaceuticals: Idebenone; Duchenne Muscular Dystrophy (DMD); Respiratory function; Ambulatory and non-ambulatory patients; Subjects not using glucocorticoids
• Additional relevant MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne; Idebenone

Study Results

Participant Flow

Recruitment Details	Recruiting centres were in Belgium, Germany, the Netherlands, Switzerland, France, Sweden, Austria, Italy, Spain, and the USA. Patients were enrolled between July 27, 2009 (study start date), and Dec 14, 2012; the study end date (last patient completed the study) was Jan 14, 2014.
Pre-assignment Detail	65 patients were randomly assigned and two patients were allocated to the same treatment as their randomly assigned siblings. One patient never took study medication, resulting in 66 patients who were treated and included in the safety population (34 in the placebo group and 32 in the idebenone group).

Arm/Group Title	Placebo	Idebenone
Arm/Group Description	Two matching placebo tablets were taken three times a day with meals	Two150 mg tablets were taken three times a day with meals (total dose 900 mg daily).
Period Title: Overall Study
STARTED	34	32
COMPLETED	30	25
NOT COMPLETED	4	7

Baseline Characteristics

Arm/Group Title	Placebo	Idebenone	Total
Arm/Group Description	Two matching placebo tablets were taken three times a day with meals	Two150 mg tablets were taken three times a day with meals (total dose 900 mg daily).	Total of all reporting groups
Overall Participants	34	32	66
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	15 (2.5)	13.5 (2.7)	14.3 (2.7)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	34 100%	32 100%	66 100%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Percent Predicted Peak Expiratory Flow (PEF) at Week 52
Description	Change from Baseline in Percent Predicted Peak Expiratory Flow (PEF) at Week 52
Time Frame	Baseline and Week 52

Outcome Measure Data

Analysis Population Description

This analysis was performed on the ITT population(n=64). This population included all randomized patients who received at least one dose of the study medication and provided at least one post-Baseline assessment. It excluded siblings who had been allocated to the same study treatment as a randomized sibling.

Arm/Group Title	Placebo	Idebenone
Arm/Group Description	Two matching placebo tablets were taken three times a day with meals	Two150 mg tablets were taken three times a day with meals (total dose 900 mg daily).
Measure Participants	33	31
Geometric Mean (95% Confidence Interval) [percentage]	-8.84	-2.57

2. Secondary Outcome

Title	Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 52
Description	Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 52
Time Frame	Baseline and Week 52

Outcome Measure Data

Analysis Population Description

This analysis was performed on the ITT population(n=64). This population included all randomized patients who received at least one dose of the study medication and provided at least one post-Baseline assessment. It excluded siblings who had been allocated to the same study treatment as a randomized sibling.

Arm/Group Title	Placebo	Idebenone
Arm/Group Description	Placebo 900 mg/day Placebo: Placebo (900 mg/day) 2 tabl (150 mg each) x 3 times orally with meals	Idebenone 900 mg/day Idebenone: Idebenone (900 mg/day) 2 tabl (150 mg each) x 3 times orally with meals
Measure Participants	33	31
Mean (95% Confidence Interval) [percentage of Predicted FVC]	-8.95	-5.67

3. Secondary Outcome

Title	Change From Baseline to Week 52 in Muscle Strength
Description	The change from Baseline to Week 52 in muscle strength as measured by Hand-Held Myometry (HHM) was performed following standardized procedures. As almost all patients were non-ambulatory, only analyses of upper limb muscle strength were performed. Results for elbow flexors and for elbow extensors are reported below.The highest value of 3 consecutive measurements with an interval of at least 10 seconds were recorded. The HHM was measured using MicroFET2, a digital hand held muscle tester. The selected unit of measure was Newtons (N).
Time Frame	Baseline and Week 52

Outcome Measure Data

Analysis Population Description

The number of patients (N) in each treatment group is the number of patients with baseline assessments

Arm/Group Title	Placebo	Idebenone
Arm/Group Description	Two matching placebo tablets were taken three times a day with meals	Two150 mg tablets were taken three times a day with meals (total dose 900 mg daily).
Measure Participants	27	25
Elbow Flexors	0.13	-2.32
Elbow Extensors	1.32	0.26

4. Secondary Outcome

Title	Change From Baseline to Week 52 in Quality of Life Assessed by PedsQL™ Paediatric Quality of Life Inventory
Description	PedsQL Quality of Life Inventory contains paediatric HRQOL measurements: Physical, Emotional,Social and School Functioning. Item Scaling: 5-point Likert scale from 0 (Never) to 4 (Almost always). 3-point scale: 0 (Not at all), 2 (Sometimes) and 4 (A lot) for the Young Child (ages 5-7). Scores are transformed on a scale from 0 to 100 ( 0=100, 1=75, 2=50, 3=25, 4=0) Total Score: Sum of all the items over the number of items answered on all the Scales. The values reported below are overall scores on Paediatric Quality of Life Inventory in Child/Teen Report. These scores were obtained by averaging scores for all the described subscales. The overall scores range between 0-100 with 0 = worst outcome and 100= best outcome
Time Frame	Baseline and Week 52

Outcome Measure Data

Analysis Population Description

The number of patients (N) in each treatment group is the number of patients with Baseline assessments.

Arm/Group Title	Placebo	Idebenone
Arm/Group Description	Two matching placebo tablets were taken three times a day with meals	Two150 mg tablets were taken three times a day with meals (total dose 900 mg daily).
Measure Participants	33	30
Mean (95% Confidence Interval) [units on a scale]	2.46	-1.34

5. Secondary Outcome

Title	Percentage of Patients Reporting Adverse Events
Time Frame	52 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Idebenone
Arm/Group Description	Two matching placebo tablets were taken three times a day with meals	Two150 mg tablets were taken three times a day with meals (total dose 900 mg daily).
Measure Participants	34	32
Number [percentage of patients reporting AEs]	94.1	93.8

Adverse Events

Arm/Group Title	Placebo		Idebenone
Arm/Group Description	Two matching placebo tablets were taken three times a day with meals		Two150 mg tablets were taken three times a day with meals (total dose 900 mg daily).
All Cause Mortality
	Placebo		Idebenone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		Idebenone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/34 (14.7%)		2/32 (6.3%)
Gastrointestinal disorders
Vomitig	1/34 (2.9%)		0/32 (0%)
General disorders
Pyrexia	1/34 (2.9%)	1	0/32 (0%)	0
Infections and infestations
Pneumonia	2/34 (5.9%)	3	0/32 (0%)	0
Nasopharyngitis	1/34 (2.9%)	1	0/32 (0%)	0
Injury, poisoning and procedural complications
Femur fracture	1/34 (2.9%)	1	0/32 (0%)	0
Metabolism and nutrition disorders
Dehydration	1/34 (2.9%)	1	0/32 (0%)	0
Musculoskeletal and connective tissue disorders
Tendinous contracture	1/34 (2.9%)	2	0/32 (0%)	0
Psychiatric disorders
Sleep apnoea syndrome	0/34 (0%)		1/32 (3.1%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	1/34 (2.9%)	1	0/32 (0%)	0
Pulmunary microemboli	1/34 (2.9%)	1	0/32 (0%)	0
Respiratory failure	0/34 (0%)	0	1/32 (3.1%)	1
Skin and subcutaneous tissue disorders
Urticaria	0/34 (0%)	0	1/32 (3.1%)	1
Other (Not Including Serious) Adverse Events
	Placebo		Idebenone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	32/34 (94.1%)		30/32 (93.8%)
Blood and lymphatic system disorders
Blood phosporus increased	3/34 (8.8%)	4	1/32 (3.1%)	1
Cardiac disorders
Left ventricular failure	1/34 (2.9%)	1	3/32 (9.4%)	3
Electrocardiogram abnormal	1/34 (2.9%)	1	2/32 (6.3%)	3
Gastrointestinal disorders
Diarrhoea	4/34 (11.8%)	6	8/32 (25%)	10
Constipation	6/34 (17.6%)	6	3/32 (9.4%)	4
Abdominal pain	3/34 (8.8%)	5	3/32 (9.4%)	4
Nausea	2/34 (5.9%)	2	1/32 (3.1%)	2
Vomiting	2/34 (5.9%)	3	1/32 (3.1%)	1
General disorders
Pyrexia	3/34 (8.8%)	4	5/32 (15.6%)	6
Influenza like illness	1/34 (2.9%)	2	2/32 (6.3%)	2
Infections and infestations
Nasopharyngitis	9/34 (26.5%)	11	8/32 (25%)	12
Upper respiratory tract infection	6/34 (17.6%)	10	2/32 (6.3%)	2
Gastroenteritis	1/34 (2.9%)	1	6/32 (18.8%)	7
Rhinitis	6/34 (17.6%)	8	1/32 (3.1%)	1
Otitis media	0/34 (0%)	0	3/32 (9.4%)	3
Musculoskeletal and connective tissue disorders
Back pain	4/34 (11.8%)	6	2/32 (6.3%)	2
Scoliosis	1/34 (2.9%)	1	2/32 (6.3%)	2
Nervous system disorders
Headache	7/34 (20.6%)	15	6/32 (18.8%)	13
Renal and urinary disorders
Chromaturia	0/34 (0%)	0	3/32 (9.4%)	3
Respiratory, thoracic and mediastinal disorders
Bronchitis	6/34 (17.6%)	7	4/32 (12.5%)	5
Rhinorrhoea	2/34 (5.9%)	2	3/32 (9.4%)	3
Nasal congestion	1/34 (2.9%)	1	2/32 (6.3%)	2
Oropharyngeal pain	1/34 (2.9%)	1	2/32 (6.3%)	2
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis	2/34 (5.9%)	2	1/32 (3.1%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.