Intralesional steroid: there is a trial with a clear comparator, and steroid alone was the arm that lost

A 2025 randomised controlled trial at a tertiary hospital in Puducherry, India.

72 patients aged 18 and over, with keloids at any site and no prior treatment, took part. They were randomised into two arms.

• Group A — intralesional triple combination: triamcinolone acetonide plus 5-fluorouracil plus hyaluronidase
• Group B — intralesional triamcinolone acetonide alone

Treatments ran every three weeks for four sessions, or until complete flattening. Assessment used the Vancouver Scar Scale every three weeks, then monthly for three months after treatment ended.

Results:

• Group A — 0.58 ± 0.5 (7.08%) at three weeks, rising to 4.47 ± 1.29 (54.55%) at final follow-up
• Group B — 0.08 ± 0.28 (0.95%) at three weeks, rising to 3.08 ± 0.81 (36.65%)
• Group A was significantly better at every time point (p < 0.05)

Post-procedure pain lasting a few hours occurred in three patients in A and two in B, with no difference between groups (p = 0.642). No one had a recurrence during the study.

Now how to read it.

We carry the authors' own stated limitations across: small sample, single centre, short follow-up, no blinding, and no patient-reported outcome measures.

Of those, no blinding weighs particularly heavily on this endpoint. The Vancouver Scar Scale is not a machine reading; it is a score a person assigns by eye. If the assessor knew which arm a patient was in, that score can lean toward expectation.

This is the same thing we wrote on PRP and subcision. Who assigned the score matters as much as the badge.

So it sits at 'early evidence'. Randomised, with 72 people, is not a bad size for this layer; the missing blinding does not allow more.

Same trial, same 72 people. The entry above was the comparison between arms. This one is the part where each arm improved against its own baseline.

The paper reports that both groups improved significantly from baseline at every follow-up. The steroid-alone arm ended up 36.65% better.

But there was no untreated arm in this trial.

Here is why that matters.

Keloids sometimes flatten a little on their own over time. And participants in a scar trial generally live differently for the duration — avoiding sun, reducing irritation. With no control arm, all of that is counted as the injection's work.

This is the recurring problem of this whole layer. As the PRP page says, almost every randomised trial in aesthetic medicine is A versus B, and that design cannot separate 'both worked' from 'neither worked'.

This procedure does have one extra circumstance. Keloids are not lesions expected to resolve on their own; left alone they often grow. So an untreated arm is ethically hard to justify in the first place. We accept that, and we still do not erase the fact that there was no control.

Hence 'not established' here. This trial did not prove 'injections make it better'. What it proved goes as far as 'the triple combination beat steroid alone'.

A 2019 double-blind controlled pilot study in Dermatol Ther from Ahvaz Jundishapur University of Medical Sciences, Iran, and others. The paper's title reads: 'Intralesional triamcinolone alone or in combination with botulinum toxin A is ineffective for the treatment of formed keloid scar.'

First, why this site put this entry on this page. Intralesional corticosteroid is used as a first-line treatment for keloids, and the entries above looked at how it did when used with something else. But if a trial puts 'ineffective' in its title, that trial belongs on the same page.

The trial. 20 patients with a cumulative 40 keloids completed it.

• one arm — intralesional triamcinolone alone
• the other — intralesional triamcinolone plus botulinum toxin A

The results.

• there was no significant difference between the arms in height, vascularisation, pliability and pigmentation scores
• the arm with botulinum toxin added had significantly better pain and pruritus than triamcinolone alone (p < 0.001)

Now how to read it. This is the most important part of the entry.

First, the title and the reported comparison do not line up. The title says 'ineffective'. But the comparison the abstract reports is between the two arms. There is no arm that had nothing done to it.

No difference between the arms means 'adding botulinum toxin did not make the appearance better'. It does not mean 'triamcinolone does not work on keloids'. To write that sentence you need an untreated arm.

This site carries paper titles across as written, but when a title is put more strongly than the abstract, we write that gap down too. This entry is such a case.

Second, there is still a reason to carry this trial. As with the other entries on this page, this procedure is almost always compared against something else. And we have not yet found a trial with an untreated control. One paper with a strong title does not fill that gap. Recording that is this entry's job.

Third, 20 patients, and the authors called it a pilot study. With 40 keloids there are more lesions than people. Counting several keloids in one person separately can inflate the statistics.

Fourth, the abstract does not state the duration. So the duration field on the badge above is empty.

Fifth, one thing did separate — symptoms. There was no difference in the appearance scores, but pain and pruritus were significantly better with botulinum toxin added (p < 0.001). The distinction this site keeps returning to appears here too — what is measured and what is felt can come apart. That side is written up on the botulinum toxin page from the same trial. Do not count it as two badges.

Sixth, the authors' conclusion is 'it should be used adjuvantly'. They write that irradiation is only effective in the adjuvant setting, and that future studies of triamcinolone and botulinum toxin should be performed adjuvantly too. The 2018 trial on the cryotherapy page shows that radiotherapy side.

So it sits at 'not established'.