Treatment of frontal fibrosing alopecia with microneedling and photodynamic therapy

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Oslo University Hospital HF

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

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

Decision date (initial)

2024-01-30

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

Reduction of inflammation due to frontal fibrosing alopecia (FFA) at week 32 compared to baseline

Secondary objectives 4

1. Temporal change in FFA inflammation
2. Change in Frontal Fibrosing Alopecia (FFA) Global Staging Score
3. Change in investigators overall disease activity assessment
4. Change in participants overall disease activity assessment

Conditions and MedDRA coding

Frontal fibrosing alopecia (FFA)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. The participant must be ≥18 years of age at the time of signing the informed consent
2. The participant must fulfill the criteria for classic FFA with a grade 2 or 3 of erythema and hyperkeratosis
3. The participant must be able to communicate in Norwegian or English
4. The participant must be capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
5. Females of reproductive age must use effective

Exclusion criteria 10

1. The participant has another medical condition in the area of interest on the scalp, making MN/PDT contraindicated (e.g., melanoma, morpheaform or other invasive keratinocyte carcinoma)
2. The patient has another medical condition in the area of interest on the scalp, making the effects of MN/PDT difficult to interpret (e.g., psoriasis, seborrheic dermatitis)
3. The patient has another medical condition making MN/PDT contraindicated even if the area of interest is not affected at screening (e.g., cutaneous lupus, porphyria cutanea tarda or other porphyria)
4. The participant is pregnant or wish to become pregnant or is breastfeeding within the time frame of the study
5. The participant has current hypertension of ≥160/100 mm Hg
6. Any condition that in the view of the investigator would suggest that the patient is unable to comply with the study protocol and procedures
7. The patient has received topical corticosteroids or calcineurin inhibitors on the area of interest less than four weeks ago
8. The patient has received systemic 5-alpha reductase inhibitors less than twelve weeks ago
9. The patient has received topical anti-neoplastic therapy in the area of interest (e.g., imiquimod, 5-fluorouracil, PDT) within the last 12 weeks
10. The patient has received systemic anti-inflammatory therapy (e.g., glucocorticoids, calcineurin inhibitors, ciclosporin A, azathioprine, methotrexate, anti-TNF, anti-interleukins JAK inhibitors or retinoids) within the last 12 weeks. NSAIDs are acceptable

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Reduction of the combined scoring of erythema and hyperkeratosis at week 32 compared to baseline (week 0)

Secondary endpoints 7

1. Reduction of the combined scoring of erythema and hyperkeratosis at week 4, 8, 20 and 32 compared to baseline (week 0)
2. Reduction of the (FFA) Global Staging Score week 32 compared to baseline (week 0)
3. Change in investigators global assessment score week 32 compared to baseline (week 0)
4. Change in patient global assessment score week 32 compared to baseline (week 0)
5. Percentage reduction of hair density at week 32 (ALODEXFFA score) compared to baseline (week 0)
6. Percentage change of hair density at week 4, 8, 20 and 32 (ALODEXFFA score) compared to baseline (week 0)
7. Percentage increased hair density at week 32 compared to baseline (negative ALODEXFFA score)

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Oslo University Hospital HF

Sponsor organisation

Oslo University Hospital HF

Address

Taarnbygget, Kirkeveien 166 Kirkeveien 166

City

Oslo

Postcode

0450

Country

Norway

Scientific contact point

Organisation

Oslo University Hospital HF

Contact name

Øystein Sandanger

Public contact point

Organisation

Oslo University Hospital HF

Contact name

Øystein Sandanger

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Application history

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