Intralesional bleomycin: the numbers were good, and both trials were open-label

Two randomised trials, in Int J Dermatol (2026) and Indian Dermatol Online J (2026). Both were done in India, and both are open-label.

One — against triamcinolone (136 patients)

136 patients with clinically diagnosed keloids were randomised to bleomycin (68) or triamcinolone acetonide (68). Injections at 4-week intervals for four sessions, with follow-up 2 months after the final session. Assessment used the Vancouver Scar Scale (VSS).

• mean percentage reduction in VSS — bleomycin 72.02%, triamcinolone 58.10% (p < 0.00001)
• the proportion achieving 75% or more improvement — 36.8% (25 of 68) versus 14.7% (10 of 68) (p = 0.0027)
• vascularity, pliability and height also favoured bleomycin significantly, with mean height 0.8 mm versus 1.9 mm (p = 0.003)
• the reduction in surface area was comparable between the groups (p = 0.850)
• the authors' conclusion — both treatments improved significantly, but bleomycin was superior. Larger, multicentre, blinded studies with longer follow-up are warranted — including recurrence rates

Two — against cryotherapy (52 patients)

Treatment-naive adults with localised keloids were randomised 1:1 to spray cryotherapy or intralesional bleomycin (26 per arm), with six visits at 4-week intervals. Infected and ulcerated keloids were excluded.

• the reduction in thickness was significantly greater with bleomycin (P < 0.001)
• VSS fell significantly in both arms from the first follow-up, and was significantly lower with bleomycin from the third visit (12 weeks) onwards
• the POSAS observer score was also significantly lower with bleomycin

How to read it.

First, both are open-label. This is the most important thing in this entry. VSS and POSAS are scores a person gives by eye, and that person knew which arm the patient was in. Where the endpoint is appearance, that is not a small problem.

And this site's own field name is at odds with that fact. The 'endpoint' field is described as a blinded rater's score. These two trials were not blinded. There is no better-fitting value on this site yet, so it stays as 'graded' and the mismatch is written here.

Second, the control was another treatment, not placebo. Both are active controls. So the sentence they support is not 'it works' but 'it is better than those two'. Since both are already in use for keloids, though, it is the comparison closer to the real choice.

Third, surface area was comparable. p = 0.850. Height and pliability separated; area did not. We do not write only the good side.

Fourth, recurrence was not looked at. Follow-up in the first trial was 2 months after the last injection, and the authors themselves asked for longer studies including recurrence rates. In keloids recurrence is not a secondary question — the same sentence is on the intralesional 5-fluorouracil page.

Fifth, both trials are from one country. Given that keloid prevalence differs with skin colour, that cuts both ways — being material from where keloids are common is a strength, and being one country is a gap.

Sixth, it conflicts with another page here. The 24-trial network meta-analysis cited on the 5-FU page recorded bleomycin monotherapy as 'intermediate, without statistical superiority'. The two trials above are later and head-to-head. Which is right cannot be settled from this material. The meta-analysis includes indirect comparisons; these two trials are unblinded. Their weaknesses are different ones.

So it sits at 'moderate'. An appearance score without blinding cannot carry it higher.

The adverse effects reported by the same 136-patient trial. This entry stands separately because those numbers run in the opposite direction to the efficacy numbers.

• bleomycin's side — pain 74% (50 patients), hyperpigmentation 26% (18 patients)
• triamcinolone's side — skin atrophy 24% (16 patients), telangiectasia 22% (15 patients)

How to read it.

First, pain was 74%. Three in four. It is the place on this site where the pain field has to be written highest.

Second, hyperpigmentation is more visible on darker skin. And that overlaps with where keloids are more common. The 26% has to be read in that context.

Third, triamcinolone's adverse effects are a different kind. Thinning skin and visible vessels are changes that are hard to reverse. Pain passes; thinned skin stays. The 24% and the 26% cannot be read at the same weight.

Fourth, that fixes the character of this comparison. It is not 'which is better' but 'which adverse effect can you accept'. That judgement depends on where the scar is, on skin colour, and on which one you mind more. It is a conversation for a clinic.

Fifth, this endpoint mixes what the patient said with what was observed. Pain is self-reported; pigment and skin thickness are observed. In that case this site records it on the self-report side — writing it at the weaker end is the rule.

So it sits at 'moderate'. And the reason this entry has to be the same size as the one above is that showing efficacy and burying adverse effects below it is itself a screen tilted one way.