Abstract | BACKGROUND: The well-known active chlorine compound chloramine T (CAT) with broad-spectrum antimicrobial activity is in common therapeutic use for leg ulcers with purulent coatings; however, this treatment is painful. The tolerability of the less aggressive N-chlorotaurine (NCT), an endogenous compound also produced in vivo by stimulated human granulocytes, could be superior. OBJECTIVES: To assess the tolerability and efficacy of NCT in the cleaning of purulent coatings in chronic leg ulcers in comparison with CAT. METHODS: In a double-blind, randomized phase IIb clinical study 40 patients were treated for a median of 7 days (range 3-14) with a 1% aqueous solution of either NCT (20 subjects) or CAT (20 subjects) by twice-daily application of dressings soaked in the test solutions. Criteria for evaluation of tolerability were intensity and duration of pain caused by the ulcer therapy and scores of tissue toxicity ( necrosis, granulation tissue and re-epithelialization). Therapeutic efficacy was graded as scores of intensity of purulent coating of the ulcers. RESULTS: The concentration tolerated in vitro by human epidermoid carcinoma cells was at least 10-fold higher for NCT (0.01%) compared with CAT (0.0001-0.001%). There was significantly less pain caused by NCT compared with CAT (P < 0.05) on days 1 and 4 and a trend for a shorter duration of pain (P = 0.093). The scores of intensity of coating improved without difference in both treatment groups, whereas granulation and re-epithelialization appeared earlier in the NCT group (P < 0.05). Non-quantitative microbiological cultures from ulcer smears revealed persistence of colonization by bacterial species in approximately half of both treatment groups. CONCLUSIONS: Both active chlorine compounds were helpful in reducing purulent coatings. Because of its lower toxicity and better tolerability, NCT is of advantage in the treatment of leg ulcers.
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Authors | M Nagl, V A Nguyen, W Gottardi, H Ulmer, R Höpfl |
Journal | The British journal of dermatology
(Br J Dermatol)
Vol. 149
Issue 3
Pg. 590-7
(Sep 2003)
ISSN: 0007-0963 [Print] England |
PMID | 14510994
(Publication Type: Clinical Trial, Clinical Trial, Phase II, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anti-Infective Agents, Local
- Chloramines
- Dermatologic Agents
- Tosyl Compounds
- chloramine-T
- Taurine
- N-chlorotaurine
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Topics |
- Administration, Topical
- Adult
- Aged
- Aged, 80 and over
- Anti-Infective Agents, Local
(adverse effects, therapeutic use)
- Chloramines
(adverse effects, therapeutic use)
- Chronic Disease
- Dermatologic Agents
(adverse effects, therapeutic use)
- Double-Blind Method
- Drug Evaluation
- Female
- Humans
- Leg Ulcer
(drug therapy, physiopathology)
- Male
- Middle Aged
- Pain
(prevention & control)
- Taurine
(adverse effects, analogs & derivatives, therapeutic use)
- Tosyl Compounds
(adverse effects, therapeutic use)
- Treatment Outcome
- Wound Healing
(drug effects)
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