Abstract | BACKGROUND: OBJECTIVE: METHODS: The study was divided into two phases. In phase I, azithromycin was prepared over a range of ethanol/water concentrations to determine solubility. The stability of a 2% azithromycin in 60% ethanol/water preparation was assessed by high-pressure liquid chromatography. The temperature, light, and pH dependence of the stability was also assessed. In phase II, a single center, randomized, double-blind, treatment-controlled study compared once-nightly application of topical 2% azithromycin versus 2% erythromycin. A total of 20 subjects with moderate inflammatory acne and 20 with rosacea were examined clinically at 0, 2, 4, 8, and 12 weeks for a 12-week period. Efficacy was evaluated with the Physician's Visual Analog Scale evaluation ( PVAS), the papulopustule count, and acne severity rating (in subjects with acne). RESULTS: In phase I, azithromycin was soluble in 60% ethanol/water. A 2% azithromycin in 60% ethanol/water solution maintained stability at room temperature for up to 26 weeks but at 37 degrees C there was some decay (16%) at 26 weeks. The stability was greatest at pH 6.8 and was unaffected by ambient light exposure. In phase II, the number of inflammatory lesions decreased in both acne and rosacea subjects treated with 2% erythromycin (7.56, p=0.03 and 4.4, p=0.01, respectively). Azithromycin was not as effective for the treatment of rosacea. Both azithromycin (p=0.01) and erythromycin (p=0.03) treatment significantly reduced the inflammatory lesion count in acne vulgaris. No significant adverse events were identified in the acne group. In patients with rosacea, transient irritation occurred in five patients. CONCLUSIONS:
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Authors | R C McHugh, A Rice, N D Sangha, M A McCarty, R Utterback, J M Rohrback, B E Osborne, A B Fleischer Jr, S R Feldman |
Journal | The Journal of dermatological treatment
(J Dermatolog Treat)
Vol. 15
Issue 5
Pg. 295-302
(Sep 2004)
ISSN: 0954-6634 [Print] England |
PMID | 15370397
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial)
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Chemical References |
- Anti-Bacterial Agents
- Solutions
- Erythromycin
- Azithromycin
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Topics |
- Acne Vulgaris
(drug therapy, pathology)
- Administration, Topical
- Adolescent
- Adult
- Anti-Bacterial Agents
(administration & dosage, adverse effects)
- Azithromycin
(administration & dosage, adverse effects)
- Chemistry, Pharmaceutical
- Child
- Double-Blind Method
- Drug Stability
- Erythromycin
(administration & dosage)
- Female
- Humans
- Male
- Rosacea
(drug therapy, pathology)
- Solutions
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