A study to evaluate the efficacy and safety of Clascoterone solution in treatment of male pattern hair loss.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Cassiopea S.p.A., Cassiopea S.p.A.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

21 Nov 2023 → 17 Jul 2025

Decision date (initial)

2023-10-30

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Cassiopea S.p.A.

External identifiers

EU CT number

2023-504421-39-00

ClinicalTrials.gov

NCT05914805

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

Pivotal, Double-Blind – Part 1: The objective of the first 6 months of study is to evaluate the efficacy and safety of Clascoterone solution BID dosing compared to the vehicle solution BID for the treatment of androgenetic alopecia (AGA) in adult males.

Conditions and MedDRA coding

Androgenetic Alopecia

Study design 2 periods

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Subject who is male ≥18 years old.
2. Subject who has provided written informed consent.
3. Subject who has mild to moderate AGA in temple and vertex region, rating III vertex to V on the Modified Norwood-Hamilton Scale (i.e., III vertex [IIIv], IV, or V), with a history of ongoing hair loss.
4. Subject who is willing to maintain the same hairstyle, hair length and hair color throughout the study.
5. Subject who is willing to comply with study instructions at home and return to the clinic for required visits.
6. Subject who agrees to continue his shampoo frequency and other general hair care products and regimen for the entire study.
7. Subject who agrees to maintain same dietary and supplement pattern.
8. Subjects who are sexually active with a female partner and are not surgically sterile (vasectomy performed at least 6 months prior to treatment) must agree to use an acceptable form of birth control as described in the informed consent form. For subjects, adequate forms of contraception include condom and spermicide in combination with other forms of female contraception. For females, an acceptable method (Pearl Index <1%) would be to agree to use implants, injectables, combined oral contraceptives, some intrauterine devices, or be postmenopausal (defined as amenorrhea greater than 12 consecutive months in women 50 years of age or older), be surgically sterile (hysterectomy, bilateral tubal ligation [at least 6 months prior], or bilateral oophorectomy).

Exclusion criteria 18

1. Subject who has any dermatological disorders of the scalp in the target region with the possibility of interfering with the application of the IMP or examination method, such as fungal or bacterial infections, seborrheic dermatitis, psoriasis, eczema, folliculitis, scars, or scalp atrophy.
2. Subject who has any skin pathology or condition that, in the investigator’s opinion, could interfere with the evaluation of the IMP or requires use of interfering topical, systemic (e.g., uncontrolled thyroid disease, certain genetic disorders that involve hair growth or patterns), or surgical therapy.
3. Subject who has current or recent history (within 6 months) of hair weaves, non-breathable wigs, or hair bonding.
4. Subject who had scalp hair transplants at any time.
5. Subject with a history of active hair loss due to diffuse telogen effluvium, alopecia areata, scarring alopecia, trichotillomania, or conditions/diseases other than AGA.
6. Subject who has a current or recent history (within 6 months) of severe dietary or weight changes or has a history of eating disorder(s), any history of bariatric surgery (gastric bypass, gastric sleeve, stomach stapling); macro- or micro-nutrient deficiencies within the last 6 months (i.e.: clinically significant iron deficiency, protein deficiency confirmed by lab testing) and/or any current diagnosis of malabsorptive disease (i.e.: Celiac, Irritable Bowel disease etc.).
7. Subject who has any condition which, in the investigator’s opinion, would make it unsafe for the subject to participate in this study, including 12-lead electrocardiogram (ECG) findings during the screening period.
8. Subject is currently enrolled in an investigational drug or device study.
9. Subject who has used an investigational drug or investigational device treatment within 30 days or 5 half-lives whichever is longer prior to Visit 2/Baseline.
10. Subject who is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.
11. Subject who has used or is suspected, in the investigator’s opinion, to be using anabolic steroids.
12. Subject who may be unreliable for the study, including subjects who engage in excessive alcohol intake or drug abuse, and/or subjects who will be unable to return for scheduled follow-up visits.
13. Subject who has a known hypersensitivity or previous allergic reaction to any of the active or inactive ingredients in the IMPs or tattoo ink.
14. Subject who has used any of the following topical preparations or procedures on the scalp: a) Topical scalp treatments for hair growth including minoxidil, Aminexil, hormone therapy, anti-androgens, or other agents that are known to affect hair growth within 12 weeks of Visit 2/Baseline. b) Topical scalp over-the-counter (OTC) or cosmetic treatments known or reasonably believed to affect hair growth (e.g., brands such as Maxilene, Nioxin, Foltene, etc.) or hair health or hair growth products with saw palmetto, copper, etc. within 2 weeks of Visit 2/Baseline. c) Topical scalp treatments that may have ancillary effect on hair growth including, but not limited to, corticosteroids, pimecrolimus, tacrolimus, and retinoids within 4 weeks of Visit 2/Baseline. d) Scalp procedures (surgical, laser, light, or energy treatments, micro- needling, etc.) within 6 months of Visit 2/Baseline. e) Platelet rich plasma (PRP) procedure on the scalp within 6 months of Visit 2/Baseline.
15. Subject who has used one or more of the following systemic medications or procedures: a) Beta blockers, cimetidine, diazoxide, or corticosteroids (including intramuscular and intralesional injections) within 12 weeks of Visit 2/Baseline. Inhaled, intranasal, or ocular corticosteroids are allowed if use is stable [defined as doses and frequency unchanged for at least 4 weeks prior to Visit 2/Baseline]. b) Retinoid, isotretinoin, vitamin A intake above 10,000 IU per day, or cyclosporine therapy within 6 months of Visit 2/Baseline. c) Any 5 alpha reductase medications (i.e.: Finasteride [Propecia®, etc.], Dutasteride or similar products within 6 months of Visit 2/Baseline. d) Chemotherapy or cytotoxic agents at any time. e) Radiation of the scalp at any time point. f) Other systemic therapy, which in the opinion of the investigator, may materially affect the subject’s hair or hair growth, including, but not limited to, spironolactone, vitamin or homeopathy supplement hair growth or hair health products or other steroid hormones (in any form), including anabolic steroids during the 3 months prior to baseline or during the study.
16. Subject who has been previously enrolled in any study with Clascoterone (former CB-03-01).
17. Subject who is an employee or direct relative of an employee of the contract research organization (CRO), the study site, or the Sponsor.
18. Subject who is institutionalized because of legal or regulatory order.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Co-Primary Efficacy Endpoints: Changes from Pivotal Part 1 Baseline in non-vellus TAHC at Month 6. / Subject’s assessment of own hair coverage at Month 6, defined as the proportion of MAA-PRO core measure item 2 responder at Month 6.

Secondary endpoints 1

1. 1) Changes from Pivotal Part 1 Baseline in non-vellus TAHC at Month 3. 2) Changes in MAA-PRO SI single treatment satisfaction item (item 15) score at Month 6.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Cassiopea S.p.A.

Sponsor organisation

Cassiopea S.p.A.

Address

Via Cristoforo Colombo 1

City

Lainate

Postcode

20045

Country

Italy

Scientific contact point

Organisation

Cassiopea S.p.A.

Contact name

Clinical Project Manager

Public contact point

Organisation

Cassiopea S.p.A.

Contact name

Clinical Project Manager

Third parties 7

Cassiopea S.p.A.

Sponsor organisation

Cassiopea S.p.A.

Address

Via Cristoforo Colombo 1

City

Lainate

Postcode

20020

Country

Italy

Scientific contact point

Organisation

Cassiopea S.p.A.

Contact name

Clinical Operation Manager

Public contact point

Organisation

Cassiopea S.p.A.

Contact name

Clinical Operation Manager

Third parties 7

Locations

2 EU/EEA countries · 16 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 40 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

9 submissions — initial application plus substantial / non-substantial modifications