Breaking Out, Episode 2: Cabtreo — one gel, two countries, and a coverage map that is not one map

Where this is taking place

Two completed Phase 3 trials (NCT04214639 / NCT04214652) enrolled people 9 and older with moderate or severe facial acne. The labels are 12+. Canadian sites were real: Barrie and Waterloo (Study 301); Winnipeg, Oakville, and Peterborough (Study 302). Those studies are finished. They are not a 2026 slot.

Commercial gel: prescription product, community pharmacy, US and Canada. SAP is the wrong door in Canada — DPD status Marketed as of 7 October 2024.

The only recruiting interventional Cabtreo study is NCT07524946: ages 9 to 11, United States only. That is an FDA PREA paediatric study. It is not how a 12-year-old gets Cabtreo.

CHARM (NCT07205107) is observational, 12+, Canada only, not recruiting. You already have to be prescribed Cabtreo as routine care. It does not supply the drug.

Approval matrix (acne vulgaris)

Do not drop EU/UK/AU/JP/CH because Canada authorized. Use the label of the country that will prescribe.

Access by country

• Canada (12+ labelled use): GP, NP, or dermatologist can prescribe. Community pharmacy. Do not ask for SAP. Under 12: not labelled; the recruiting paediatric study is US-only 9–11, not a Canadian door.
• Ontario — opened: LU 724 (pcg9Id=840404031): 12+ acne vulgaris, 1 year. Listing 30 Jun 2025, DBP 3.0074.
• Quebec — opened: minister Inscrire 14 Aug 2025. RAMQ Covered. Criteria beyond Covered unknown.
• Alberta — opened, narrower: ADBL SA, PDF effective 1 Apr 2026, scarring/severe acne, 6 months. That is not Ontario LU 724.
• NIHB — opened: open benefit, no prior approval.
• Saskatchewan — opened: Bulletin 256, Full Formulary Benefit (not EDS).
• Nova Scotia — opened: Appendix III Aug 2026: regular benefit 30 and under; exception-status over 30 for acne vulgaris.
• BC: live PharmaCare unknown. PAD non-benefit is not live PharmaCare.
• PEI / NB / NL: unknown.
• United States: FDA-labelled 12+. Dermatology or a clinician who already treats acne. Community pharmacy. Prior authorization still applies. OrthoRxAccess commercial copay exists on cabtreo.com/hcp/access-and-savings — government-insured excluded. No dollar amount on this page. No US cash price on the patient page.
• EU / UK / Australia / Japan / Switzerland: marketing authorisation not found. Do not invent named-patient, SAS, or import. Ask a local clinician about labelled alternatives (including dual combos that are not this triad).
• If your regulator has not labelled it: do not import on your own.

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What it actually is

Cabtreo is clindamycin phosphate 1.2% (1% clindamycin), adapalene 0.15%, and benzoyl peroxide 3.1% in a once-daily topical gel. Code IDP-126. One pump, three mechanisms: antibiotic, retinoid, peroxide.

It is not:

• Winlevi (clascoterone)
• isotretinoin
• Duac, Epiduo, or any other dual combo — those are different licences
• labelled under 12
• an EMA, MHRA, or TGA product on
• a Canadian SAP drug

Dose (US and Canadian labels): once daily to affected skin. Photosensitivity; may bleach fabric and hair; do not wax treated skin. Stop and call if diarrhea (clindamycin / colitis risk).

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What the trials showed (plain numbers)

IDs. NCT04214639 (Study 301 / Trial 1) and NCT04214652 (Study 302 / Trial 2). Combined labelled n=363 from DailyMed / HC PM, not from JAAD. 2:1 Cabtreo vs vehicle, once daily, 12 weeks. Sponsor: Bausch Health Americas, Inc. PMID 37656094 is those two Phase 3s: Stein Gold L, Lain E, Del Rosso JQ, et al. J Am Acad Dermatol. 2023;89(5):927–935 (Henry Ford).

Research team (paper, not a clinic directory).

• Lead / corresponding: Linda Stein Gold, Henry Ford Hospital / Henry Ford Health.
• Industry: Bausch Health / Ortho Dermatologics (US); Bausch Health, Canada Inc.
• Names as they appear on primary sources.

Who got in. Protocol age ≥9; labels 12+. Moderate or severe facial acne. Co-primaries at week 12: EGSS success (clear/almost clear and ≥2-grade drop); absolute change in inflammatory lesions; absolute change in noninflammatory lesions.

Week 12 labelled numbers (US PI Table 3 = HC PM Table 7 — DailyMed/PM, not JAAD):

About half of people on drug hit “clear or almost clear and a two-grade drop.” That is a bigger success rate than Winlevi’s week-12 IGA table. It is still not “everyone clears.” Head-to-head vs using the three drugs as separate tubes was not the registrational design.

Limitations. Pivotals were moderate–severe. The indication has no severity grade. Under-12 was enrolled in small numbers and not authorized. Canada pregnancy rules are stricter than the US label.

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Safety a household should actually watch

Local (US PI, n=242 Cabtreo vs 121 vehicle): application-site pain 13.6% vs 0.8%; erythema 4.5% vs 0; dryness 4.1% vs 0.8%; irritation 2.1%; exfoliation 1.7%; dermatitis 1.2%. Discontinuation for local reactions 2.5%. Moisturizer in the first month is a reasonable ask, not a hack.

Both labels — do not start if:

• hypersensitivity to clindamycin, lincomycin, adapalene, or benzoyl peroxide
• Crohn’s disease, ulcerative colitis, or antibiotic-associated colitis

Pregnancy — do not smear the two labels together:

• United States: not a contraindication. Insufficient human data. Discuss uncertainty.
• Canada: CONTRAINDICATED in pregnant women and women planning a pregnancy. If pregnancy happens on drug, stop.

Both: photosensitivity; bleach fabric/hair; do not wax treated skin; diarrhea means call, not wait.

Under 12: not labelled. The open US study (NCT07524946) is not a back door onto the 12+ pump.

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Access: what you can actually do

1. This is a labelled, marketed gel in the US and Canada. SAP is the wrong door.

Health Canada’s Special Access Programme is for drugs not marketed in Canada. Cabtreo has been marketed here since 7 October 2024. The usual path is: prescription of a labelled product, then a fight over which plan’s criteria you meet.

2. Who to see

A family doctor, nurse practitioner, or dermatologist who already treats acne. You do not need an isotretinoin clinic. Under 12 is a different conversation (US paediatric trial only; Canada not authorized).

Bring: age, pregnancy/planning status, IBD / prior C. difficile colitis history, allergy list (clindamycin, lincomycin, adapalene, BPO), other acne products, and which province’s card you hold.

3. Script for the visit

Cabtreo is labelled in Canada (NOC 14 August 2024, DIN 02550423) and the US (FDA 20 October 2023) for acne vulgaris in people 12 and older. I am 12 or older. I am not asking for SAP. Can you prescribe the labelled gel, and which coverage path applies — Ontario LU 724 (12+, 1 year), Alberta scarring/severe SA (6 months), Quebec Inscrire (14 Aug 2025), Saskatchewan full formulary, Nova Scotia regular benefit at 30 and under, NIHB open benefit, private insurance, or cash? I understand Alberta’s rule is narrower than the Product Monograph. If I am pregnant or planning a pregnancy, the Canadian label contraindicates it.

Ask:

1. Acne vulgaris, age 12+?
2. Pregnancy / planning (Canada CI; US discuss)?
3. Crohn’s, UC, or prior antibiotic-associated colitis?
4. Allergy to clindamycin, lincomycin, adapalene, BPO?
5. Coverage: ON LU 724 vs AB scarring/severe SA vs SK full formulary vs NS ≤30 regular benefit vs QC Covered (criteria unknown / not confirmed on this page) vs BC unknown?
6. Do not ask for SAP in Canada for labelled 12+ use.

4. Public coverage: do not collapse provinces

• CDA-AMC SR0794-000: Reimburse with conditions, 12+ acne vulgaris. Final 18 Oct 2024. Price: do not exceed already-reimbursed topical acne therapies. Submitted-to-CDA (not ODB list): $147.42 per 50 g; sponsor annual figure ~$1,616/patient/year at that list.
• pCPA 22902: concluded with LOI 2025-04-04 (not the 9 Apr PR). Direct page 404; net price not public.
• Ontario: LU 724 full text (pcg9Id=840404031): 12+ acne vulgaris, 1 year. Listing 30 Jun 2025, DBP 3.0074.
• Quebec: minister Inscrire 14 Aug 2025. RAMQ Covered. Criteria beyond Covered unknown.
• Alberta: ADBL SA, PDF effective 1 Apr 2026, scarring/severe, 6 months. Not Ontario LU 724.
• NIHB: open benefit, no PA.
• Saskatchewan: Bulletin 256, Full Formulary Benefit (not EDS).
• Nova Scotia: Appendix III Aug 2026 — regular benefit 30 and under; exception-status over 30 for acne vulgaris.
• BC: live PharmaCare unknown. PAD non-benefit is not live PharmaCare.
• PEI / NB / NL: unknown.

NOC ≠ the same listing in every province. Repeat it.

5. Private insurance and cash

Ask the clinic to submit prior authorization as acne vulgaris / Cabtreo / 12+, not “hormonal acne.” US OrthoRxAccess is a commercial copay on the HCP page; government-insured excluded. Canadian cabtreo.ca is education, not a named copay. No Canadian PSP phone on.

6. Clinical trials

The registrational studies are completed. NCT04214639 and NCT04214652 are not a 2026 enrolment path. NCT07524946 is 9–11, US only — not this episode. CHARM NCT07205107 does not supply drug. No other recruiting interventional 12+ Cabtreo/IDP-126 trial found.

7. If the answer is “not a candidate”

Under 12, pregnancy/planning in Canada, IBD/colitis history, or living where the triad is not authorised need a different plan — dual combos that are labelled, Winlevi (Episode 1), or isotretinoin (Episode 3). Cabtreo is not a substitute for Accutane and not a European import on this evidence.

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Bottom line

Cabtreo is a real, labelled, once-daily three-drug gel for people 12 and older with acne vulgaris — in the United States and Canada. In two Phase 3 trials, about half of people on drug hit investigator “success” at 12 weeks versus about one in four / one in five on vehicle. That is why regulators said yes.

The 2026 fight is the map. Ontario LU 724 is 12+ acne, one year. Alberta is scarring/severe, six months. Saskatchewan is full formulary. Nova Scotia is a regular benefit at 30 and under. Quebec’s minister said Inscrire on 14 Aug 2025. BC’s live listing is unknown. Europe and the UK do not have a marketing authorisation on. SAP is the wrong door. The recruiting trial is nine to eleven years old, in the US. Use the label of the country that will prescribe, and the formulary of the province that will pay.

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Primary sources

1. US FDA. NDA 216632 approval letter, 20 Oct 2023. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/216632Orig1s000ltr.pdf
2. DailyMed. CABTREO (clindamycin phosphate, adapalene, and benzoyl peroxide) gel. setid 9468da0f-9978-4c58-8135-0274c3415084. Label revised Mar 2025. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9468da0f-9978-4c58-8135-0274c3415084
3. Health Canada DPD. CABTREO, DIN 02550423. Marketed 2024-10-07. https://dhpp.hpfb-dgpsa.ca/dhpp/resource/103924
4. Health Canada RDS. Control / resource RDS1732553051076. Sponsor asked 9+; HC authorized 12+. https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1732553051076
5. Health Canada Product Monograph. https://pdf.hres.ca/dpd_pm/00076715.PDF
6. ClinicalTrials.gov. NCT04214639 (Barrie ON, Waterloo ON). https://clinicaltrials.gov/study/NCT04214639
7. ClinicalTrials.gov. NCT04214652 (Winnipeg MB, Oakville ON, Peterborough ON). https://clinicaltrials.gov/study/NCT04214652
8. ClinicalTrials.gov. NCT07524946 (Phase 4, 9–11 y, US only, recruiting). https://clinicaltrials.gov/study/NCT07524946
9. ClinicalTrials.gov. NCT07205107 CHARM (observational, 12+, Canada; does not supply drug). https://clinicaltrials.gov/study/NCT07205107
10. PMID 37656094 = the two Phase 3 pivotals (Stein Gold, Henry Ford). JAAD 2023;89(5):927–935. Labelled EGSS/n are DailyMed/PM, not this paper.
11. CDA-AMC. SR0794-000 Cabtreo. Reimburse with conditions. Final 18 Oct 2024. https://www.cda-amc.ca/sites/default/files/DRR/2024/SR0794_Recommendation.pdf
12. pCPA file 22902. Concluded with LOI 2025-04-04 (not the 9 Apr PR).
13. Ontario Formulary LU 724 full text, pcg9Id=840404031. 12+ acne vulgaris, 1 year. Listing 2025-06-30, DBP 3.0074. https://www.formulary.health.gov.on.ca/formulary/detail.xhtml?drugId=02550423
14. Alberta ADBL Special Authorization, PDF effective 1 Apr 2026: scarring/severe acne, 6 months. Distinct from ON LU 724.
15. Quebec minister Inscrire 14 Aug 2025. RAMQ Covered, DIN 02550423. Criteria beyond Covered unknown.
16. NIHB / SAC-ISC program updates: Cabtreo gel open benefit, no prior approval. https://sac-isc.gc.ca/eng/1578079214611/1578079236012
17. EMA PIP EMEA-003263-PIP01-22 (not an MA). https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003263-pip01-22
18. OrthoRxAccess HCP page (US commercial copay; government-insured excluded). https://www.cabtreo.com/hcp/access-and-savings
19. BC live PharmaCare: unknown. PAD 22 Jun 2026 non-benefit is not live PharmaCare.
20. Saskatchewan Formulary Bulletin 256: Full Formulary Benefit (not EDS).
21. Nova Scotia Pharmacare Appendix III, Aug 2026. Regular benefit ≤30; exception-status over 30 for acne vulgaris. https://novascotia.ca/dhw/pharmacare/documents/Criteria-for-Exception-Status-Coverage.pdf

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Medcelerator Breaking Out Episode 2 draft. Access lock 2026-09-02. Reviewer before studio. Not live. Not a substitute for a clinician who treats acne. Kids’ names out. Episodes 3–4 still sit.