Randomized clinical trial to compare oral isotretinoin to standard of care in moderate acne skin of color patients

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Nice

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years

Gender

Male and Female

Therapeutic area

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

Trial duration

29 Apr 2025 → ongoing

Decision date (initial)

2024-03-12

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To assess the superiority at M6 of an early treatment of moderate facial acne in skin of color patients of oral isotretinoin compared to the current standard of care on the severity of ARP

Secondary objectives 4

1. To compare the efficacy after 6 months of isotretinoin versus standard of care in the subgroup of patients with no or very mild ARP at baseline (ARP score<2) and in the subgroup of patients presenting already with ARP at baseline (ARP score ≥2) (see below for the description of the ARP score)
2. To compare the efficacy of early isotretinoin versus standard of care on retentional and inflammatory acne lesions after 3 and 6 months
3. To evaluate the tolerance of the two protocols of treatment in skin of color patients
4. To assess the evolution of the quality of life of patients who will receive early treatment with isotretinoin compared to the standard of care over the study period.

Conditions and MedDRA coding

Acne

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Women and men between 13 and 30-year-old
2. Skin type IV, V and VI according to Fitzpatrick skin types
3. Moderate acne as defined by the French Society of Dermatology recommendations based on ECLA grading https://document.sfdermato.org/groupe/centre-de-preuves/label-recommandations-acne-post-college.pdf)
4. Patients must have a cell phone able to take selfies pictures with a minimum definition of 5Mb.
5. Signed informed consent
6. Affiliation to French social coverage

Exclusion criteria 10

1. Mild and severe acne (ECLA grading : French recommendations) (https://document.sfdermato.org/groupe/centre-de-preuves/label-recommandations-acne-post-college.pdf)
2. Past cure of oral isotretinoin
3. Past cure of systemic antibiotics for acne in the last 6 months
4. Phototype I-III patients
5. Abnormal hemogram, liver enzyme, cholesterol, triglycerides at baseline
6. Pregnancy: female patient of childbearing potential will undergo a pregnancy test (plasmatic β-hCG)
7. Breast-feeding patients
8. Refusal of effective contraception for women
9. Contra-indications to oral isotretinoin, doxycycline, lymecycline, topical adapalene/tretinoin
10. Vulnerable people: adult under guardianship or deprived of freedom

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. ARP severity score assessed by dedicated algorithm on facial pictures (selfies) at M6. This algorithm, developed to assess face skin aging hyperpigmented lesions is validated in ARP in dark skin types. The score ranges from 0 (no ARP) to 4 (severe ARP). A success is a patient with a score < 2 at M6 (ARP score<2 shows no or very mild ARP).

Secondary endpoints 4

1. Efficacity in subgroups will be evaluated as in main criteria at M6. The two subgroups will be patients with no or mild ARP at the inclusion (ARP score assessed by the algorithm on selfie <2) and the patients with already moderate to severe ARP (ARP score > or =2) at the inclusion.
2. The inflammatory and retentional lesions count will be assessed by dedicated algorithm on facial pictures (selfies) at 3 months and at 6 months. We will consider their evolution at M3 and M6 compared to baseline. Also, the evolution of inflammatory and retentional lesions will be assessed clinically by using the GEA scale grading.
3. Number, grade and severity of adverse events in the two groups wil be presented. A special focus on scars will be performed using an IGA score (0 no scar, 1 mild scarring, 2 moderate, 3 severe) over the study period. For adolescent, ADRS (Adolescent Depression Rating Scale) will be additionally performed at each visit.
4. Quality of life will be evaluated with the Acne-specific Quality of Life questionnaire (Acne-QoL)

Investigational products

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

Test 3

Comparator 5

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Nice

Sponsor organisation

Centre Hospitalier Universitaire De Nice

Address

4 Avenue Reine Victoria

City

Nice

Postcode

06000

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Nice

Contact name

Investigator coordonator

Public contact point

Organisation

Centre Hospitalier Universitaire De Nice

Contact name

Investigator coordonator

Locations

1 EU/EEA country · 20 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 22 files

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

Application history

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