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Clinical Trial Results:
A PHASE 2, MULTICENTER, PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, VEHICLE-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CB 03 01 (CORTEXOLONE 17α-PROPIONATE) SOLUTION FOR THE TREATMENT OF ANDROGENETIC ALOPECIA IN MALES

Summary
EudraCT number	2016-003733-23
Trial protocol	DE
Global end of trial date	06 Jan 2019

Results information
Results version number	v1(current)
This version publication date	08 Aug 2020
First version publication date	08 Aug 2020
Other versions

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

CB-03-01/34

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

Cassiopea S.p.A.

Sponsor organisation address

Via C. Colombo, 1, Lainate (MI), Italy, 20045

Public contact

R&D department, Cassiopea S.p.A., +39 0286891124,

Scientific contact

R&D department, Cassiopea S.p.A., +39 0286891124,

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

20 Sep 2019

Is this the analysis of the primary completion data?

Yes

Primary completion date

06 Jan 2019

Global end of trial reached?

Yes

Global end of trial date

06 Jan 2019

Was the trial ended prematurely?

Main objective of the trial

The objective of the study was to evaluate the efficacy and safety of CB-03-01 solution, 2.5%, 5.0%, 7.5% BID (twice a day) dosing and 7.5% QD (once per day) dosing compared to vehicle for the treatment of androgenetic alopecia (AGA) in males.

Protection of trial subjects

Before being admitted to the study the subjects were informed in detail about the significance, nature, scope and possible risks of the study. Written information was available for this purpose. Subjects were free to terminate their participation in the study at any time without personal disadvantages and without giving reasons. The subjects were informed that all study data would be collected and stored in an electronic database, pseudoanonymized, and handled in the strictest confidence. Randomized subjects were provided with instruction sheet, diary and study subject cards indicating the nature of the trial the subject is participating, contact details and any information needed in the event of a medical emergency.

Background therapy

No background therapy foreseen in this study.

Evidence for comparator

No comparator(s) used in this study.

Actual start date of recruitment

21 Jun 2017

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Germany: 404

Worldwide total number of subjects

404

EEA total number of subjects

404

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)

404

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

The study was carried out at six study centers in Germany. A total of 431 subjects were screened and 404 randomized. The randomization period included about 5 months. The first subject was randomized on 26JUN2017, the last subject on 01DEC2017. The study duration included about 18 months. The last subject completed the study on 06JAN2019.

Screening details

Eligible subjects were adult (18 to 55 years of age) male affected by a mild to moderate AGA with a history of ongoing hair loss in the temple and vertex region, as classified by the Modified Norwood-Hamilton Scale. The screening period ranged from Day -14 to -3. A washout phase from prohibited medications or treatments was foreseen, if necessary.

Number of subjects started

431 ^[1]

Number of subjects completed

404

Reason: Number of subjects

Failed eligibility criteria: 9

Reason: Number of subjects

Consent withdrawn by subject: 16

Reason: Number of subjects

Not specified: 2

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: the pre-assignment period is here considered as the inclusion of the subject in the screening phase of the study, so the number of subjects reported to have started the pre-assignment period is the number of subjects that were screened (Informed Consent form signed, subject study ID assigned and screening procedures started/performed).

Period 1 title

Overall trial (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Investigator, Monitor, Subject

Blinding implementation details

The various concentrations of CB-03-01 solution and vehicle solution were packaged in identical 60 ml glass amber bottles and the treatment was randomly assigned to the subjects through an IWRS. Treatment group designation at the site level remained blinded until the final database was locked. Sealed Emergency Unblinding Forms were available for each kit at the study sites for emergency unblinding.

Are arms mutually exclusive

Yes

CB-03-01 solution, 2.5% BID

Arm description

CB-03-01 solution, 2.5% BID (twice a day)

Arm type

Experimental

Investigational medicinal product name

CB-03-01 solution, 2.5%

Investigational medicinal product code

Other name

Pharmaceutical forms

Cutaneous solution

Routes of administration

Topical use

Dosage and administration details

1 mL applied to the balding areas of the scalp (vertex and temple) twice daily over a period of 12 months

CB-03-01 solution, 5% BID

Arm description

CB-03-01 solution, 5% BID (twice a day)

Arm type

Experimental

Investigational medicinal product name

CB-03-01 solution, 5%

Investigational medicinal product code

Other name

Pharmaceutical forms

Cutaneous solution

Routes of administration

Topical use

Dosage and administration details

1 mL applied to the balding areas of the scalp (vertex and temple) twice daily over a period of 12 months

CB-03-01 solution 7.5% BID

Arm description

CB-03-01 solution 7.5% BID (twice a day)

Arm type

Experimental

Investigational medicinal product name

CB-03-01 solution, 7.5%

Investigational medicinal product code

Other name

Pharmaceutical forms

Cutaneous solution

Routes of administration

Topical use

Dosage and administration details

1 mL applied to the balding areas of the scalp (vertex and temple) twice daily over a period of 12 months

CB-03-01 solution, 7.5% QD/vehicle solution QD

Arm description

CB-03-01 solution, 7.5% QD (once per day) and vehicle solution QD (once per day)

Arm type

Experimental

Investigational medicinal product name

CB-03-01 solution, 7.5% QD/ vehicle solution QD

Investigational medicinal product code

Other name

Pharmaceutical forms

Cutaneous solution

Routes of administration

Topical use

Dosage and administration details

1 mL applied to the balding areas of the scalp (vertex and temple) twice daily over a period of 12 months

Vehicle solution BID

Arm description

Vehicle solution BID (twice a day)

Arm type

Placebo

Investigational medicinal product name

Vehicle solution BID

Investigational medicinal product code

Other name

Pharmaceutical forms

Cutaneous solution

Routes of administration

Topical use

Dosage and administration details

1 mL applied to the balding areas of the scalp (vertex and temple) twice daily over a period of 12 months

Number of subjects in period 1	CB-03-01 solution, 2.5% BID	CB-03-01 solution, 5% BID	CB-03-01 solution 7.5% BID	CB-03-01 solution, 7.5% QD/vehicle solution QD	Vehicle solution BID
Started	82	78	82	80	82
Completed	78	68	70	71	73
Not completed	4	10	12	9	9
Consent withdrawn by subject	3	5	5	5	3
Adverse event, non-fatal	1	4	1	1	4
Not specified	-	-	1	-	-
Lost to follow-up	-	1	4	2	2
Protocol deviation	-	-	1	-	-
Lack of efficacy	-	-	-	1	-

Baseline characteristics

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Reporting group title

CB-03-01 solution, 2.5% BID

Reporting group description

CB-03-01 solution, 2.5% BID (twice a day)

Reporting group title

CB-03-01 solution, 5% BID

Reporting group description

CB-03-01 solution, 5% BID (twice a day)

Reporting group title

CB-03-01 solution 7.5% BID

Reporting group description

CB-03-01 solution 7.5% BID (twice a day)

Reporting group title

CB-03-01 solution, 7.5% QD/vehicle solution QD

Reporting group description

CB-03-01 solution, 7.5% QD (once per day) and vehicle solution QD (once per day)

Reporting group title

Vehicle solution BID

Reporting group description

Vehicle solution BID (twice a day)

Reporting group values	CB-03-01 solution, 2.5% BID	CB-03-01 solution, 5% BID	CB-03-01 solution 7.5% BID	CB-03-01 solution, 7.5% QD/vehicle solution QD	Vehicle solution BID	Total
Number of subjects	82	78	82	80	82	404
Age categorical
Units: Subjects
Age continuous
Units: years
arithmetic mean (standard deviation)	39.9 ( 9.71 )	41.2 ( 9.58 )	39.3 ( 9.67 )	39.8 ( 9.40 )	39.2 ( 10.15 )	-
Gender categorical
Units: Subjects
Female	0	0	0	0	0	0
Male	82	78	82	80	82	404
Ethnicity
Units: Subjects
Hispanic or Latino	1	3	6	0	0	10
Not Hispanic or Latino	81	75	76	80	82	394
Modified Norwood-hamilton Scale
Units: Subjects
Type III Vertex	32	25	36	31	28	152
Type IV	29	36	24	34	34	157
Type V	21	17	22	15	20	95

End points

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Reporting group title

CB-03-01 solution, 2.5% BID

Reporting group description

CB-03-01 solution, 2.5% BID (twice a day)

Reporting group title

CB-03-01 solution, 5% BID

Reporting group description

CB-03-01 solution, 5% BID (twice a day)

Reporting group title

CB-03-01 solution 7.5% BID

Reporting group description

CB-03-01 solution 7.5% BID (twice a day)

Reporting group title

CB-03-01 solution, 7.5% QD/vehicle solution QD

Reporting group description

CB-03-01 solution, 7.5% QD (once per day) and vehicle solution QD (once per day)

Reporting group title

Vehicle solution BID

Reporting group description

Vehicle solution BID (twice a day)

Primary: Comparison of changes from baseline in non-vellus Target Area Hair Counts (TAHC) at Month 12

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End point title

Comparison of changes from baseline in non-vellus Target Area Hair Counts (TAHC) at Month 12

End point description

Non-vellus TAHC: Comparison Month 12 vs Baseline - OC (PP Population). The change from Baseline in non-vellus TAHC at Month 12 was evaluated.

End point type

Primary

End point timeframe

Month 12

End point values	CB-03-01 solution, 2.5% BID	CB-03-01 solution, 5% BID	CB-03-01 solution 7.5% BID	CB-03-01 solution, 7.5% QD/vehicle solution QD	Vehicle solution BID
Number of subjects analysed	74	66	68	66	70
Units: Changes
number (confidence interval 95%)	1.0 (-4.2 to 6.2)	4.4 (-1.4 to 10.2)	4.7 (-0.3 to 9.8)	3.5 (-2.7 to 9.8)	-9.3 (-14.7 to -3.9)

Change from Baseline in non-vellus TAHC at month12

Statistical analysis description

The change from Baseline in non-vellus TAHC at Month 12 was evaluated by analysis of covariance including in the model treatment, visit, treatment by visit interaction and analysis center as factors and the Baseline non-vellus TAHC and Baseline non-vellus TAHC-by-visit interaction as the covariates. The covariance stucture converging to the best fit was used as the primary analysis. Pairwise comparisons for the LSM between active treatment groups and the vehicle group were evaluated.

Comparison groups

CB-03-01 solution, 2.5% BID v CB-03-01 solution, 5% BID v CB-03-01 solution 7.5% BID v CB-03-01 solution, 7.5% QD/vehicle solution QD v Vehicle solution BID

Number of subjects included in analysis

344

Analysis specification

Pre-specified

Analysis type

superiority

P-value

≤ 0.05

Method

ANCOVA; paired t-test

Confidence interval

Primary: Comparison of changes from baseline in non-vellus Target Area Hair Counts (TAHC) at Month 12 in active groups vs vehicle

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End point title

Comparison of changes from baseline in non-vellus Target Area Hair Counts (TAHC) at Month 12 in active groups vs vehicle

End point description

Non-vellus TAHC: comparison vs vehicle at Month 12 using MMRM - OC (PP population). Changes from baseline for parameter Non-vellus TAHC - OC

End point type

Primary

End point timeframe

Month 12

End point values	CB-03-01 solution, 2.5% BID	CB-03-01 solution, 5% BID	CB-03-01 solution 7.5% BID	CB-03-01 solution, 7.5% QD/vehicle solution QD	Vehicle solution BID
Number of subjects analysed	74	66	68	66	70
Units: changes
number (confidence interval 95%)	10.2 (2.6 to 17.8)	13.8 (5.9 to 21.6)	14.3 (6.6 to 22.1)	12.7 (4.9 to 20.6)	0 (0 to 0)

Non-vellus TAHC: comparison vs vehicle at Month 12

Statistical analysis description

Comparison groups

CB-03-01 solution, 2.5% BID v CB-03-01 solution, 5% BID v CB-03-01 solution 7.5% BID v CB-03-01 solution, 7.5% QD/vehicle solution QD v Vehicle solution BID

Number of subjects included in analysis

344

Analysis specification

Pre-specified

Analysis type

superiority

P-value

≤ 0.05

Method

ANCOVA; unpaired t-test

Confidence interval

Primary: Hair Grow Assesment (HGA) at Month 12

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End point title

Hair Grow Assesment (HGA) at Month 12

End point description

Hair Grow Assesment (HGA) Score at Month 12: Summary and Comparison - OC (PP Population). The frequency distribution of HGA score at Month 12 was wvaluated.

End point type

Primary

End point timeframe

Month 12

End point values	CB-03-01 solution, 2.5% BID	CB-03-01 solution, 5% BID	CB-03-01 solution 7.5% BID	CB-03-01 solution, 7.5% QD/vehicle solution QD	Vehicle solution BID
Number of subjects analysed	74	66	68	66	70
Units: Score
Greatly decreased (-3)	0	1	1	1	1
Moderately decreased (-2)	3	4	5	2	5
Slightly decreased (-1)	4	8	6	4	9
No change (0)	22	13	14	22	20
Slightly increased (1)	23	17	20	21	17
Moderately increased (2)	17	18	20	12	15
Greatly increased (3)	5	4	2	4	3

Hair Growth Assesment (HGA) at Month 12

Statistical analysis description

The frequency distribution of HGA score at Month 12 was evaluated using CMH mean score test stratified by analysis center using modified ridit score for between-group comparisons. Pairwise comparisons between active treatment groups and vehicle were evaluated. If the table were sparse, Fisher's Exact test might have been used or categories might have been collapsed for analysis.

Comparison groups

CB-03-01 solution, 2.5% BID v CB-03-01 solution, 5% BID v CB-03-01 solution 7.5% BID v CB-03-01 solution, 7.5% QD/vehicle solution QD v Vehicle solution BID

Number of subjects included in analysis

344

Analysis specification

Pre-specified

Analysis type

other

P-value

≤ 0.05 ^[1]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[1] - Even if the p-value of the comparison vs vehicle was ≥ 0.2927, positive HGA scores 1 to 3 were reported in a higher share of subjects in all 4 active treatments groups when compared to the vehicle BID group (56.1% to 61.8% vs 50%) at month 12.

Adverse events

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Timeframe for reporting adverse events

Information on the medical condition of subjects should have begun following the subject’s written informed consent to participate in the study until the date of the final study visit.

Adverse event reporting additional description

Treatment-emergent AEs (TEAEs) are AEs collected from the date of the first dose of IMP until the date of the final study visit.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

Reporting group title

CB-03-01 solution, 2.5% BID

Reporting group description

CB-03-01 solution, 2.5% BID (twice a day)

Reporting group title

CB-03-01 solution, 5% BID

Reporting group description

CB-03-01 solution, 5% BID (twice a day)

Reporting group title

CB-03-01 solution 7.5% BID

Reporting group description

CB-03-01 solution 7.5% BID (twice a day)

Reporting group title

CB-03-01 solution, 7.5% QD/vehicle solution QD

Reporting group description

CB-03-01 solution, 7.5% QD (once per day) and vehicle solution QD (once per day)

Reporting group title

Vehicle solution BID

Reporting group description

Vehicle solution BID (twice a day)

Serious adverse events	CB-03-01 solution, 2.5% BID	CB-03-01 solution, 5% BID	CB-03-01 solution 7.5% BID	CB-03-01 solution, 7.5% QD/vehicle solution QD	Vehicle solution BID
Total subjects affected by serious adverse events
subjects affected / exposed	2 / 82 (2.44%)	2 / 78 (2.56%)	0 / 82 (0.00%)	2 / 80 (2.50%)	5 / 82 (6.10%)
number of deaths (all causes)	0	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sinonasal papilloma
Additional description: This subject experienced a moderate recurrent inverted papilloma right paranasal sinus, about 4 months after first dose of IMP. The subject was hospitalized for a surgery to excise the papilloma.
subjects affected / exposed	0 / 82 (0.00%)	0 / 78 (0.00%)	0 / 82 (0.00%)	0 / 80 (0.00%)	1 / 82 (1.22%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
B-cell lymphoma
Additional description: This subject experienced a severe B-cell lymphoma, about 4 months after first dose of IMP.
subjects affected / exposed	0 / 82 (0.00%)	1 / 78 (1.28%)	0 / 82 (0.00%)	0 / 80 (0.00%)	0 / 82 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Renal neoplasm
Additional description: This subject experienced a moderate renal tumor about 10 months after first dose of IMP and was hospitalized for excision of the renal tumor.
subjects affected / exposed	1 / 82 (1.22%)	0 / 78 (0.00%)	0 / 82 (0.00%)	0 / 80 (0.00%)	0 / 82 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Squamous cell carcinoma of the oral cavity
Additional description: This subject experienced a squamous cell carcinoma of the oral cavity and an oropharyngeal neoplasm about 8 months after first IMP dose.
subjects affected / exposed	0 / 82 (0.00%)	0 / 78 (0.00%)	0 / 82 (0.00%)	0 / 80 (0.00%)	1 / 82 (1.22%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Dislocation of vertebra
Additional description: This subject experienced a moderate dislocation of cervical vertebra due to a motorcycle accident, about 6 months after first dose of IMP.
subjects affected / exposed	0 / 82 (0.00%)	0 / 78 (0.00%)	0 / 82 (0.00%)	1 / 80 (1.25%)	0 / 82 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Tendon rupture
subjects affected / exposed	0 / 82 (0.00%)	1 / 78 (1.28%)	0 / 82 (0.00%)	0 / 80 (0.00%)	0 / 82 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Limb crushing injury
Additional description: This subject experienced a moderate crush injury of the right foot due to an accident about 13 months after first dose of IMP.
subjects affected / exposed	0 / 82 (0.00%)	0 / 78 (0.00%)	0 / 82 (0.00%)	0 / 80 (0.00%)	1 / 82 (1.22%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
Peripheral venous disease
Additional description: This subject experienced a moderate chronic venous insufficiency of the right leg about 5 months after first dose of IMP and was hospitalized from for phleboplasty.
subjects affected / exposed	0 / 82 (0.00%)	0 / 78 (0.00%)	0 / 82 (0.00%)	0 / 80 (0.00%)	1 / 82 (1.22%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Appendicitis
Additional description: This subject experienced a severe appendicitis 12 months after first dose of IMP and was hospitalized on the same day for an appendectomy.
subjects affected / exposed	0 / 82 (0.00%)	0 / 78 (0.00%)	0 / 82 (0.00%)	1 / 80 (1.25%)	0 / 82 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Colon cancer
Additional description: This subject experienced a severe sigma carcinoma almost 10 months after first dose of IMP and was hospitalized for a sigma carcinoma section.
subjects affected / exposed	0 / 82 (0.00%)	0 / 78 (0.00%)	0 / 82 (0.00%)	0 / 80 (0.00%)	1 / 82 (1.22%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Emphysema
Additional description: This subject experienced a moderate pulmonary emphysema about 6 months after first dose of IMP. He was hospitalized due to this event for laboratory test controls.
subjects affected / exposed	1 / 82 (1.22%)	0 / 78 (0.00%)	0 / 82 (0.00%)	0 / 80 (0.00%)	0 / 82 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

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

Non-serious adverse events	CB-03-01 solution, 2.5% BID	CB-03-01 solution, 5% BID	CB-03-01 solution 7.5% BID	CB-03-01 solution, 7.5% QD/vehicle solution QD	Vehicle solution BID
Total subjects affected by non serious adverse events
subjects affected / exposed	40 / 82 (48.78%)	39 / 78 (50.00%)	35 / 82 (42.68%)	43 / 80 (53.75%)	53 / 82 (64.63%)
Investigations
Blood triglycerides increased
subjects affected / exposed	5 / 82 (6.10%)	6 / 78 (7.69%)	7 / 82 (8.54%)	6 / 80 (7.50%)	9 / 82 (10.98%)
occurrences all number	5	6	7	6	9
Alanine aminotransferase increased
subjects affected / exposed	2 / 82 (2.44%)	1 / 78 (1.28%)	0 / 82 (0.00%)	4 / 80 (5.00%)	0 / 82 (0.00%)
occurrences all number	2	1	0	4	0
Nervous system disorders
Headache
subjects affected / exposed	5 / 82 (6.10%)	6 / 78 (7.69%)	10 / 82 (12.20%)	8 / 80 (10.00%)	13 / 82 (15.85%)
occurrences all number	6	6	13	12	22
General disorders and administration site conditions
Application site pruritus
subjects affected / exposed	5 / 82 (6.10%)	3 / 78 (3.85%)	2 / 82 (2.44%)	2 / 80 (2.50%)	5 / 82 (6.10%)
occurrences all number	5	3	2	2	9
Application site dermatitis
subjects affected / exposed	1 / 82 (1.22%)	3 / 78 (3.85%)	0 / 82 (0.00%)	4 / 80 (5.00%)	4 / 82 (4.88%)
occurrences all number	2	3	0	4	4
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
subjects affected / exposed	22 / 82 (26.83%)	20 / 78 (25.64%)	16 / 82 (19.51%)	19 / 80 (23.75%)	22 / 82 (26.83%)
occurrences all number	35	26	23	29	32

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Were there any global substantial amendments to the protocol? No

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 Trial Results:
A PHASE 2, MULTICENTER, PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, VEHICLE-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CB 03 01 (CORTEXOLONE 17α-PROPIONATE) SOLUTION FOR THE TREATMENT OF ANDROGENETIC ALOPECIA IN MALES

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Comparison of changes from baseline in non-vellus Target Area Hair Counts (TAHC) at Month 12

Primary: Comparison of changes from baseline in non-vellus Target Area Hair Counts (TAHC) at Month 12

Primary: Comparison of changes from baseline in non-vellus Target Area Hair Counts (TAHC) at Month 12 in active groups vs vehicle

Primary: Comparison of changes from baseline in non-vellus Target Area Hair Counts (TAHC) at Month 12 in active groups vs vehicle

Primary: Hair Grow Assesment (HGA) at Month 12

Primary: Hair Grow Assesment (HGA) at Month 12

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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Clinical trials

Clinical Trial Results: A PHASE 2, MULTICENTER, PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, VEHICLE-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CB 03 01 (CORTEXOLONE 17α-PROPIONATE) SOLUTION FOR THE TREATMENT OF ANDROGENETIC ALOPECIA IN MALES

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Comparison of changes from baseline in non-vellus Target Area Hair Counts (TAHC) at Month 12

Primary: Comparison of changes from baseline in non-vellus Target Area Hair Counts (TAHC) at Month 12

Primary: Comparison of changes from baseline in non-vellus Target Area Hair Counts (TAHC) at Month 12 in active groups vs vehicle

Primary: Comparison of changes from baseline in non-vellus Target Area Hair Counts (TAHC) at Month 12 in active groups vs vehicle

Primary: Hair Grow Assesment (HGA) at Month 12

Primary: Hair Grow Assesment (HGA) at Month 12

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 PHASE 2, MULTICENTER, PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, VEHICLE-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CB 03 01 (CORTEXOLONE 17α-PROPIONATE) SOLUTION FOR THE TREATMENT OF ANDROGENETIC ALOPECIA IN MALES