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Clinical Trial Results:
A Multi-Center, Randomized, Double-Blind, Parallel-Group, Controlled Study to Assess the Efficacy, Safety and Tolerability of Oral DFD-29 Extended Release Capsules for the Treatment of Inflammatory Lesions of Rosacea over 16 weeks

Summary
EudraCT number	2016-003197-41
Trial protocol	DE
Global end of trial date	13 Sep 2018

Results information
Results version number	v1(current)
This version publication date	27 Mar 2020
First version publication date	27 Mar 2020
Other versions
Summary report(s)	Protocol Synopsis

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

DFD-29-CD-002

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

Dr. Reddy’s Laboratories Inc.

Sponsor organisation address

8-2-337, Road No. 3 Banjara Hills, Hyderabad Telangana, Hyderabad, India, 500034

Public contact

Dr. Srinivas Sidgiddi, Dr. Reddy’s Laboratories Inc., 0043 6649117209, srinivassidgiddi@drreddys.com

Scientific contact

Dr. Srinivas Sidgiddi, Dr. Reddy’s Laboratories Inc., 001 9084585362 , srinivassidgiddi@drreddys.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

07 Dec 2018

Is this the analysis of the primary completion data?

Yes

Primary completion date

13 Sep 2018

Global end of trial reached?

Yes

Global end of trial date

13 Sep 2018

Was the trial ended prematurely?

Main objective of the trial

To evaluate the efficacy of oral DFD-29 (minocycline 20 mg and 40 mg capsules) in comparison to placebo in the treatment of inflammatory lesions of rosacea for 16 weeks. To evaluate the safety and tolerability of oral DFD-29 (minocycline HCL 40mg capsules) in comparison to placebo in the treatment of inflammatory lesions of rosacea for 16 weeks.

Protection of trial subjects

Background therapy

Evidence for comparator

Although there are multiple therapeutic options available for the treatment of papulopustular rosacea, the most widely used systemic agents are oral tetracycline derivatives, particularly doxycycline and minocycline. Oraycea® (doxycycline 40 mg capsules) was chosen as comparator as it has been approved in the US and the EU for the treatment of papulopustular rosacea. A placebo group was required in order to differentiate any investigational drug effect from any improvement that could occur solely due to the close care and medical oversight given to patients under trial conditions.

Actual start date of recruitment

26 Sep 2017

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Germany: 205

Worldwide total number of subjects

205

EEA total number of subjects

205

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

167

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

205 male and female subjects over the age of 18 diagnosed with papulopustular rosacea were recruited across 17 sites in Germany. Fist patient first visit occured on 26 September 2017 and the last patient was recruited 10 July 2018.

Screening details

Subjects had to be diagnosed with of papulopustular rosacea, IGA grade 2 - 4 had to fulfill the following main criteria: 1. 10 - 40 (both inclusive) inflammatory lesions (papules and pustules) of rosacea over the face. 2. not more than 2 nodules 3. moderate to severe erythema with a total score of 5 - 20 on the CEA scale 4. good general health

Number of subjects started

219 ^[1]

Number of subjects completed

205

Reason: Number of subjects

Adverse event, non-fatal: 1

Reason: Number of subjects

Consent withdrawn by subject: 9

Reason: Number of subjects

Protocol deviation: 1

Reason: Number of subjects

Screening failure: 1

Reason: Number of subjects

Unknown: 1

Reason: Number of subjects

Missing: 1

Notes
[1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: Only subjects that succesfully completed the Screening period were assigned to a treatment, and randomized (enrolled). However, all subjects that underwent screening assessments signed an informed consent

Period 1 title

Treatment (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor

Blinding implementation details

There were no differences between DFD-29 (40mg and 20mg), Oraycea (40mg) capsules and placebo capsules in shape, size, colour or weight. The manufacturing organization was strictly independent from the sponsor’s activities. No accidental unblinding by laboratory measurements was possible.

Are arms mutually exclusive

Yes

DFD-29 (minocycline HCl) Extended Release Capsules (40 mg)

Arm description

Arm type

Experimental

Investigational medicinal product name

DFD-29 (minocycline HCl) Extended Release Capsules (40 mg)

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule, hard

Routes of administration

Oral use

Dosage and administration details

1 capsule once daily in the morning for 16 weeks

DFD-29 (minocycline HCl) Extended Release Capsules (20 mg)

Arm description

Arm type

Experimental

Investigational medicinal product name

DFD-29 (minocycline HCl) Extended Release Capsules (20 mg)

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule, hard

Routes of administration

Oral use

Dosage and administration details

1 capsule once daily in the morning for 16 weeks

Oraycea® (doxycycline) Modified Release Hard Capsules (40 m

Arm description

Arm type

Active comparator

Investigational medicinal product name

Oraycea® (doxycycline) Modified Release Hard Capsules (40 mg)

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule, hard

Routes of administration

Oral use

Dosage and administration details

1 capsule once daily in the morning for 16 weeks

Placebo Capsules

Arm description

Arm type

Placebo

Investigational medicinal product name

Placebo Capsules

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule, hard

Routes of administration

Oral use

Dosage and administration details

1 capsule once daily in the morning for 16 weeks

Number of subjects in period 1	DFD-29 (minocycline HCl) Extended Release Capsules (40 mg)	DFD-29 (minocycline HCl) Extended Release Capsules (20 mg)	Oraycea® (doxycycline) Modified Release Hard Capsules (40 m	Placebo Capsules
Started	53	50	49	53
Completed	47	38	40	35
Not completed	6	12	9	18
Consent withdrawn by subject	3	1	3	6
Adverse event, non-fatal	2	4	2	4
Subject developed and exclusion criterion	-	1	-	-
Unknown	-	2	1	3
Use of prohibited medication	-	3	2	3
Wrongful enrolment	-	-	-	1
Lost to follow-up	-	1	-	1
Protocol deviation	1	-	1	-

Baseline characteristics

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Reporting group title

DFD-29 (minocycline HCl) Extended Release Capsules (40 mg)

Reporting group description

Reporting group title

DFD-29 (minocycline HCl) Extended Release Capsules (20 mg)

Reporting group description

Reporting group title

Oraycea® (doxycycline) Modified Release Hard Capsules (40 m

Reporting group description

Reporting group title

Placebo Capsules

Reporting group description

Reporting group values	DFD-29 (minocycline HCl) Extended Release Capsules (40 mg)	DFD-29 (minocycline HCl) Extended Release Capsules (20 mg)	Oraycea® (doxycycline) Modified Release Hard Capsules (40 m	Placebo Capsules	Total
Number of subjects	53	50	49	53	205
Age categorical
Units: Subjects
Adults (18-64 years)	45	40	40	42	167
From 65-84 years	8	10	8	11	37
From 85 and over	0	0	1	0	1
Gender categorical
Units: Subjects
Female	34	34	29	27	124
Male	19	16	20	26	81

Subject analysis set title

Efficacy

Subject analysis set type

Full analysis

Subject analysis set description

This analysis population included all subjects who have been randomized and had at least one post baseline efficacy assessment. The FAS was the primary population for the efficacy analyses.

Subject analysis set title

Safety

Subject analysis set type

Safety analysis

Subject analysis set description

This analysis population included subjects who had at least one safety assessment post-baseline. The safety population will be employed in the analysis of tolerability and safety variables.

Subject analysis set title

ITT

Subject analysis set type

Intention-to-treat

Subject analysis set description

This analysis population includes all subjects who have been randomized and dispensed the study drug.

Subject analysis set title

Per Protocol

Subject analysis set type

Per protocol

Subject analysis set description

This analysis population comprised all subjects who did not violate the protocol in a way that might have affected the evaluation of the effect of the study drug(s) on the primary endpoint, i.e., without major protocol violations or deviations.

Subject analysis sets values	Efficacy	Safety	ITT	Per Protocol
Number of subjects	200	201	205	158
Age categorical
Units: Subjects
Adults (18-64 years)	164	165	167	131
From 65-84 years	35	35	37	27
From 85 and over	1	1	1	0
Age continuous
Units:
	( )	( )	( )	( )
Gender categorical
Units: Subjects
Female	123	123	124	94
Male	77	78	81	64

End points

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Reporting group title

DFD-29 (minocycline HCl) Extended Release Capsules (40 mg)

Reporting group description

Reporting group title

DFD-29 (minocycline HCl) Extended Release Capsules (20 mg)

Reporting group description

Reporting group title

Oraycea® (doxycycline) Modified Release Hard Capsules (40 m

Reporting group description

Reporting group title

Placebo Capsules

Reporting group description

Subject analysis set title

Efficacy

Subject analysis set type

Full analysis

Subject analysis set description

This analysis population included all subjects who have been randomized and had at least one post baseline efficacy assessment. The FAS was the primary population for the efficacy analyses.

Subject analysis set title

Safety

Subject analysis set type

Safety analysis

Subject analysis set description

This analysis population included subjects who had at least one safety assessment post-baseline. The safety population will be employed in the analysis of tolerability and safety variables.

Subject analysis set title

ITT

Subject analysis set type

Intention-to-treat

Subject analysis set description

This analysis population includes all subjects who have been randomized and dispensed the study drug.

Subject analysis set title

Per Protocol

Subject analysis set type

Per protocol

Subject analysis set description

Primary: Proportion of subjects with IGA (modified scale without erythema) ‘treatment success’ – Grade ‘0’ or ‘1’ at the end of study with at least a 2 grade reduction from Baseline to Week 16.

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End point title

Proportion of subjects with IGA (modified scale without erythema) ‘treatment success’ – Grade ‘0’ or ‘1’ at the end of study with at least a 2 grade reduction from Baseline to Week 16.

End point description

Investigator's Global Assessment (IGA, modified scale without erythema) was carried out by visual inspection by the Investigator at every study visit from Screening up to Week 16 (or at early termination) and formed part of the clinical assessment of efficacy

End point type

Primary

End point timeframe

Assessment of this endpoints were conducted at following visits: Baseline, Day 29 (+/- 5 days), Day 57 (+/- 5 days), Day 85 (+/- 5 days), Day 113 (+/- 5 days)

End point values	DFD-29 (minocycline HCl) Extended Release Capsules (40 mg)	DFD-29 (minocycline HCl) Extended Release Capsules (20 mg)	Oraycea® (doxycycline) Modified Release Hard Capsules (40 m	Placebo Capsules	Efficacy	ITT	Per Protocol
Number of subjects analysed	53	47	48	52	200	205	158
Units: percent
number (not applicable)	66.04	31.91	33.33	11.54	36	38.05	41.14

Chi-square test

Comparison groups

DFD-29 (minocycline HCl) Extended Release Capsules (40 mg) v DFD-29 (minocycline HCl) Extended Release Capsules (20 mg) v Oraycea® (doxycycline) Modified Release Hard Capsules (40 m v Placebo Capsules

Number of subjects included in analysis

200

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.05

Method

Chi-squared

Confidence interval

Primary: Total inflammatory lesion count (sum of papules, pustules, and nodules) reduction from Baseline to Week 16.

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End point title

Total inflammatory lesion count (sum of papules, pustules, and nodules) reduction from Baseline to Week 16.

End point description

The total inflammatory lesion count was carried out by visual inspection by the investigator at every study visit from Screening up to Week 16 (or at early termination). Inflammatory lesions were recorded on a diagram of a human face, divided in 4 quadrants.

End point type

Primary

End point timeframe

Assessment of this endpoints were conducted at following visits: Baseline, Day 29 (+/- 5 days), Day 57 (+/- 5 days), Day 85 (+/- 5 days), Day 113 (+/- 5 days)

End point values	DFD-29 (minocycline HCl) Extended Release Capsules (40 mg)	DFD-29 (minocycline HCl) Extended Release Capsules (20 mg)	Oraycea® (doxycycline) Modified Release Hard Capsules (40 m	Placebo Capsules
Number of subjects analysed	53	47	48	52
Units: lesion counts
arithmetic mean (standard deviation)	-19.2 ( 9.72 )	-12.6 ( 12.92 )	-10.5 ( 15.18 )	-7.3 ( 10.12 )

Mixed model

Comparison groups

DFD-29 (minocycline HCl) Extended Release Capsules (20 mg) v Oraycea® (doxycycline) Modified Release Hard Capsules (40 m v DFD-29 (minocycline HCl) Extended Release Capsules (40 mg) v Placebo Capsules

Number of subjects included in analysis

200

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.05

Method

Mixed models analysis

Confidence interval

Secondary: Proportion of subjects with at least a 2 grade reduction in IGA (modified scale without erythema) score from Baseline to Week 16

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End point title

Proportion of subjects with at least a 2 grade reduction in IGA (modified scale without erythema) score from Baseline to Week 16

End point description

End point type

Secondary

End point timeframe

Assessment of this endpoints were conducted at following visits: Baseline, Day 29 (+/- 5 days), Day 57 (+/- 5 days), Day 85 (+/- 5 days), Day 113 (+/- 5 days)

End point values	DFD-29 (minocycline HCl) Extended Release Capsules (40 mg)	DFD-29 (minocycline HCl) Extended Release Capsules (20 mg)	Oraycea® (doxycycline) Modified Release Hard Capsules (40 m	Placebo Capsules	Efficacy	ITT	Per Protocol
Number of subjects analysed	53	47	48	52	200	205	158
Units: percent
number (not applicable)	69.81	36.17	37.50	17.31	40.5	42.4	46.2

Chi-square test

Comparison groups

Number of subjects included in analysis

200

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.05

Method

Chi-squared

Confidence interval

Secondary: Median change in total RosaQoL score from Baseline to Week 16.

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End point title

Median change in total RosaQoL score from Baseline to Week 16.

End point description

The RosaQoL assessment was carried out by the Investigator by asking questions as per the validated RosaQoL questionnaire instrument, at every study visit from Screening up to Week 16 (or at early termination). The subjects had to rate on a 5 grade scale their perception of the impact that rosacea had on various dimensions influencing their quality of life.

End point type

Secondary

End point timeframe

Assessment of this endpoints were conducted at following visits: Baseline, Day 29 (+/- 5 days), Day 57 (+/- 5 days), Day 85 (+/- 5 days), Day 113 (+/- 5 days)

End point values	DFD-29 (minocycline HCl) Extended Release Capsules (40 mg)	DFD-29 (minocycline HCl) Extended Release Capsules (20 mg)	Oraycea® (doxycycline) Modified Release Hard Capsules (40 m	Placebo Capsules
Number of subjects analysed	53	47	48	52
Units: RosaQol Score
arithmetic mean (standard deviation)	-14.0 ( 15.58 )	-9.5 ( 9.94 )	-4.7 ( 10.42 )	-1.7 ( 10.44 )

Kruskal-Wallis Test

Comparison groups

Number of subjects included in analysis

200

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.05

Method

Kruskal-wallis

Confidence interval

Adverse events

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Timeframe for reporting adverse events

After Baseline, all new findings or worsening of a pre-existing finding (if considered clinically significant) had to be reported as Adverse event. Data pertaining to AEs were collected during each study visit.

Adverse event reporting additional description

At each study visit, the Investigator asked a general question, e.g."Have you experienced any other/new health problems since your last visit?" Furthermore, clinically significant findings of the physical examination, vital signs, ECG, laboratory assessments and Urinalysis were considered AEs.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

18.0

Reporting group title

DFD-29 (minocycline HCl) Extended Release Capsules (40 mg)

Reporting group description

All patients randomized to receive DFD-29 (minocycline HCl) Extended Release Capsules (40 mg)

Reporting group title

DFD-29 (minocycline HCl) Extended Release Capsules (20 mg)

Reporting group description

All Patients randomized to receive DFD-29 (minocycline HCl) Extended Release Capsules (20 mg)

Reporting group title

Oraycea® (doxycycline) Modified Release Hard Capsules (40 mg)

Reporting group description

All Patients randomized to receive Oraycea® (doxycycline) Modified Release Hard Capsules (40 mg)

Reporting group title

Placebo Capsules

Reporting group description

All Patients randomized to receive placebo

Serious adverse events	DFD-29 (minocycline HCl) Extended Release Capsules (40 mg)	DFD-29 (minocycline HCl) Extended Release Capsules (20 mg)	Oraycea® (doxycycline) Modified Release Hard Capsules (40 mg)	Placebo Capsules
Total subjects affected by serious adverse events
subjects affected / exposed	1 / 53 (1.89%)	2 / 48 (4.17%)	2 / 48 (4.17%)	0 / 52 (0.00%)
number of deaths (all causes)	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
subjects affected / exposed	0 / 53 (0.00%)	0 / 48 (0.00%)	1 / 48 (2.08%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Papilloma
subjects affected / exposed	0 / 53 (0.00%)	0 / 48 (0.00%)	1 / 48 (2.08%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Coronary artery disease
subjects affected / exposed	1 / 53 (1.89%)	0 / 48 (0.00%)	0 / 48 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Atrial fibrillation
subjects affected / exposed	0 / 53 (0.00%)	1 / 48 (2.08%)	0 / 48 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Eye disorders
Retinal detachment
subjects affected / exposed	0 / 53 (0.00%)	1 / 48 (2.08%)	0 / 48 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	DFD-29 (minocycline HCl) Extended Release Capsules (40 mg)	DFD-29 (minocycline HCl) Extended Release Capsules (20 mg)	Oraycea® (doxycycline) Modified Release Hard Capsules (40 mg)	Placebo Capsules
Total subjects affected by non serious adverse events
subjects affected / exposed	39 / 53 (73.58%)	40 / 48 (83.33%)	37 / 48 (77.08%)	35 / 52 (67.31%)
Vascular disorders
Hypertension
subjects affected / exposed	2 / 53 (3.77%)	1 / 48 (2.08%)	3 / 48 (6.25%)	0 / 52 (0.00%)
occurrences all number	2	2	4	0
Nervous system disorders
Headache
subjects affected / exposed	22 / 53 (41.51%)	14 / 48 (29.17%)	13 / 48 (27.08%)	13 / 52 (25.00%)
occurrences all number	47	35	37	29
General disorders and administration site conditions
Fatigue
subjects affected / exposed	3 / 53 (5.66%)	1 / 48 (2.08%)	2 / 48 (4.17%)	0 / 52 (0.00%)
occurrences all number	3	1	2	0
Ear and labyrinth disorders
Vertigo
subjects affected / exposed	3 / 53 (5.66%)	1 / 48 (2.08%)	1 / 48 (2.08%)	0 / 52 (0.00%)
occurrences all number	3	1	2	0
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	3 / 53 (5.66%)	0 / 48 (0.00%)	1 / 48 (2.08%)	1 / 52 (1.92%)
occurrences all number	5	0	1	3
Abdominal pain upper
subjects affected / exposed	2 / 53 (3.77%)	3 / 48 (6.25%)	3 / 48 (6.25%)	3 / 52 (5.77%)
occurrences all number	2	3	9	3
Diarrhoea
subjects affected / exposed	4 / 53 (7.55%)	4 / 48 (8.33%)	2 / 48 (4.17%)	3 / 52 (5.77%)
occurrences all number	5	4	2	7
Dyspepsia
subjects affected / exposed	2 / 53 (3.77%)	1 / 48 (2.08%)	3 / 48 (6.25%)	2 / 52 (3.85%)
occurrences all number	3	1	3	2
Flatulence
subjects affected / exposed	0 / 53 (0.00%)	3 / 48 (6.25%)	0 / 48 (0.00%)	0 / 52 (0.00%)
occurrences all number	0	3	0	0
Nausea
subjects affected / exposed	4 / 53 (7.55%)	2 / 48 (4.17%)	4 / 48 (8.33%)	1 / 52 (1.92%)
occurrences all number	5	2	4	1
Skin and subcutaneous tissue disorders
Acne
subjects affected / exposed	1 / 53 (1.89%)	0 / 48 (0.00%)	3 / 48 (6.25%)	0 / 52 (0.00%)
occurrences all number	2	0	3	0
Pruritus
subjects affected / exposed	0 / 53 (0.00%)	1 / 48 (2.08%)	4 / 48 (8.33%)	2 / 52 (3.85%)
occurrences all number	0	1	4	2
Rosacea
subjects affected / exposed	0 / 53 (0.00%)	2 / 48 (4.17%)	2 / 48 (4.17%)	4 / 52 (7.69%)
occurrences all number	0	2	2	4
Musculoskeletal and connective tissue disorders
Back pain
subjects affected / exposed	2 / 53 (3.77%)	4 / 48 (8.33%)	4 / 48 (8.33%)	6 / 52 (11.54%)
occurrences all number	2	4	6	6
Infections and infestations
Nasopharyngitis
subjects affected / exposed	11 / 53 (20.75%)	8 / 48 (16.67%)	7 / 48 (14.58%)	6 / 52 (11.54%)
occurrences all number	11	11	7	8
Vulvovaginal mycotic infection
subjects affected / exposed	0 / 53 (0.00%)	3 / 48 (6.25%)	0 / 48 (0.00%)	0 / 52 (0.00%)
occurrences all number	0	3	0	0

More information

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Were there any global substantial amendments to the protocol? Yes

29 May 2017

The 4 treatment arms in the study were changed from 10 mg, 20 mg, 40 mg DFD-29 (minocycline HCL) and placebo to 20 mg and 40 mg DFD-29 (minocycline HCl), 40 mg Oraycea® (doxycycline) and placebo. In addition to the changes stated below, minor typographic errors have been corrected.

01 Aug 2017

The Study medication label was updated with regard to the amount contained in a bottle, contact information, storage conditions and overall information content of the label. Instead of Annex 13 to the Current Edition of the Good Manufacturing Practices Guidelines Drugs Used in Clinical Trials (GUI-0036) GCP guideline is followed.

26 Feb 2018

Some of the available study medication kits are expiring on July 31st 2018 and stratification of the randomization per site and IGA score resulted in a high number of kits to be stored at the individual study sites. In order to be able to use up the study medication kits with limited stability, the amount of kits on site needs to be reduced thus the stratification by IGA score is dropped.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results:
A Multi-Center, Randomized, Double-Blind, Parallel-Group, Controlled Study to Assess the Efficacy, Safety and Tolerability of Oral DFD-29 Extended Release Capsules for the Treatment of Inflammatory Lesions of Rosacea over 16 weeks

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Proportion of subjects with IGA (modified scale without erythema) ‘treatment success’ – Grade ‘0’ or ‘1’ at the end of study with at least a 2 grade reduction from Baseline to Week 16.

Primary: Proportion of subjects with IGA (modified scale without erythema) ‘treatment success’ – Grade ‘0’ or ‘1’ at the end of study with at least a 2 grade reduction from Baseline to Week 16.

Primary: Total inflammatory lesion count (sum of papules, pustules, and nodules) reduction from Baseline to Week 16.

Primary: Total inflammatory lesion count (sum of papules, pustules, and nodules) reduction from Baseline to Week 16.

Secondary: Proportion of subjects with at least a 2 grade reduction in IGA (modified scale without erythema) score from Baseline to Week 16

Secondary: Proportion of subjects with at least a 2 grade reduction in IGA (modified scale without erythema) score from Baseline to Week 16

Secondary: Median change in total RosaQoL score from Baseline to Week 16.

Secondary: Median change in total RosaQoL score from Baseline to Week 16.

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

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Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials

Clinical Trial Results: A Multi-Center, Randomized, Double-Blind, Parallel-Group, Controlled Study to Assess the Efficacy, Safety and Tolerability of Oral DFD-29 Extended Release Capsules for the Treatment of Inflammatory Lesions of Rosacea over 16 weeks

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Proportion of subjects with IGA (modified scale without erythema) ‘treatment success’ – Grade ‘0’ or ‘1’ at the end of study with at least a 2 grade reduction from Baseline to Week 16.

Primary: Proportion of subjects with IGA (modified scale without erythema) ‘treatment success’ – Grade ‘0’ or ‘1’ at the end of study with at least a 2 grade reduction from Baseline to Week 16.

Primary: Total inflammatory lesion count (sum of papules, pustules, and nodules) reduction from Baseline to Week 16.

Primary: Total inflammatory lesion count (sum of papules, pustules, and nodules) reduction from Baseline to Week 16.

Secondary: Proportion of subjects with at least a 2 grade reduction in IGA (modified scale without erythema) score from Baseline to Week 16

Secondary: Proportion of subjects with at least a 2 grade reduction in IGA (modified scale without erythema) score from Baseline to Week 16

Secondary: Median change in total RosaQoL score from Baseline to Week 16.

Secondary: Median change in total RosaQoL score from Baseline to Week 16.

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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Clinical Trial Results:
A Multi-Center, Randomized, Double-Blind, Parallel-Group, Controlled Study to Assess the Efficacy, Safety and Tolerability of Oral DFD-29 Extended Release Capsules for the Treatment of Inflammatory Lesions of Rosacea over 16 weeks