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Biomedical subjects

C Mauck

Publications and source records attributed to C Mauck.

13 recordsLinked to original sources
PubMed2001

Recommendations for the clinical development of topical microbicides: an update.

Topical microbicides are products that are being developed to prevent HIV infection and other sexually transmitted diseases (STD) through topical application to the genital and rectal epithelial surfaces. This paper is an update of the clinical section of a general guidance for the development and evaluation of microbicidal products that was first published by the International Working Group on Microbicides (IWGM) in 1996. (The preclinical section of that document will be updated separately later.) All topical microbicides should be clinically evaluated in humans for safety and effectiveness. Safety studies are necessary to evaluate the potential for systemic absorption and toxicity as well as local toxic effects, such as irritation, ulceration, burning, and itching. Reported symptoms of burning and itching are relevant to future product use and acceptability. Irritation and ulceration of the vaginal, cervical, penile, or rectal epithelium have the potential to result in an increased transmission of HIV and other STD. Effectiveness studies to assess the prevention of HIV infection or STD, depending upon the product indication, are subsequently conducted. These trials need to be large enough to detect clinically meaningful levels of protection. For spermicidal microbicides, additional contraceptive effectiveness studies are also needed.

Administration, Topical↗
PubMed2001

Cellulose sulfate: tolerance and acceptability of penile application.

Sodium cellulose sulfate (CS) is under development as a vaginal microbicide and spermicide. This was a Phase I, randomized, double-blind study of men to assess acceptability, safety, and degree of penile irritation of seven consecutive daily doses of CS compared to an active control containing nonoxynol-9 (Conceptrol). The data suggest that CS gel is not more irritating to the male genitalia than Conceptrol. This, along with the minimal irritation seen in a Phase I safety study in women following 6 consecutive days of vaginal administration, suggests that CS could be used in future studies, without undue risk, where couples engage in vaginal intercourse. Male volunteers in future studies should be informed that 1 out of 24 participants in the CS group in this study experienced tingling and slight stinging for a brief time after exposure compared with 3 out of 12 in the Conceptrol group who reported similar symptoms.

Adult↗
PubMed2001

Single and multiple exposure tolerance study of cellulose sulfate gel: a Phase I safety and colposcopy study.

Vaginally applied gels offer a promising approach for preventing unwanted pregnancies and sexually transmitted infections. Cellulose sulfate (CS) is a non-cytotoxic antifertility agent that also exhibits in vitro antimicrobial activity against sexually transmitted pathogens, including HIV. This was a randomized, double-blinded, Phase I study of 2.5 mL and 5.0 mL doses of 6% CS gel. A single vaginal application of the gel followed by five consecutive daily doses was assessed for genital irritation, safety, vaginal leakage, and product acceptability compared to two controls, Conceptrol, which is a marketed contraceptive gel containing nonoxynol-9, and K-Y jelly. The results suggest that the safety of 6% CS was comparable to that of Conceptrol and K-Y jelly, and it may be associated with less genital irritation. The 2.5 mL dose of CS may be preferable according to the participants' reports of leakage. All the products had similar acceptability profiles.

Administration, Intravaginal↗
PubMed2000

[Vertical distraction osteogenesis of the alveolar process using a tooth-borne device].

Since the communication of McCarthy et al. in 1992, applications for distraction osteogenesis in the maxillofacial complex have increased enormously. The advantages as compared to conventional reconstructive procedures are missing donor-site morbidity for bone graft harvesting, reduced blood loss and also a gradual gain in the soft tissue envelope. Meanwhile, even the vertical lengthening of the alveolar process has become a clinically reliable method. The case presented illustrates the treatment of a 16-year-old patient who suffered a sporting accident at the age of 7 years, leading to ankylosis of the upper middle incisors with subsequent underdevelopment of the frontal alveolar process. After fabrication of a custom-made distraction device, an osteotomy of the tooth-bearing segment in the upper front was performed and the segment was attached to the distraction device. Bone lengthening was started on the seventh postoperative day at a daily rate of 0.5 mm. The distraction was maintained until closure of the open bite was achieved. On the 22nd day, the segment was fixed using an orthodontic arch wire and the distraction device was removed. A retention period of 6 weeks was maintained until sufficient stability was detectable. Now, 1.5 years after the treatment, the situation is stable with a good consolidation of the bone fragments and a physiologically shaped gingivobuccal sulcus. Lengthening of the alveolar process by vertical distraction osteogenesis using a tooth-borne device may be indicated in certain cases. With this technique a second operation can be avoided and there is less risk of laceration of dental roots by fixation screws.

Adolescent↗
PubMed2000

Comparative evaluation of three Tactylon(TM) condoms and a latex condom during vaginal intercourse: breakage and slippage.

This study compared breakage and slippage rates of three male condom styles made of Tactylon(TM), a synthetic elastomer, to those of a marketed latex condom during vaginal intercourse. Safety and acceptability outcomes were also assessed. This two-center, prospective, crossover study enrolled 443 couples. Each couple was randomly assigned to use three condoms of each type in one of 24 use sequences. Couples completed questionnaires after using each condom, all of one condom type, and all four condom types. The percentage and standard error (SE, in parentheses) of latex condoms with clinical breakage was 0.86% (0.295). Percentages for Tactylon condoms were not equivalent to the latex study condom, ranging from 3.50% to 4.17%. The percentage and SE of latex condoms with complete slippage was 1.11% (0.328). Percentages for Tactylon condoms were equivalent to those for latex, ranging from 0.70% to 1.31%. The Low-Modulus Tactylon condom was the most preferred. Fewer medical events were reported with the Tactylon condoms than with the latex condom. It was concluded that Tactylon condoms were equivalent to the latex condom in terms of slippage but not breakage. However, safety and acceptability seemed to be better for Tactylon condoms. This may improve consistency of use and may attract new users.

Adolescent↗
PubMed1999

A comparative study of the safety and efficacy of FemCap, a new vaginal barrier contraceptive, and the Ortho All-Flex diaphragm. The FemCap Investigators' Group.

The FemCap is a new silicone rubber barrier contraceptive shaped like a sailor's hat, with a dome that covers the cervix, a rim that fits into the fornices, and a brim that conforms to the vaginal walls around the cervix. It was designed to result in fewer dislodgments and less pressure on the urethra than the cervical cap and diaphragm, respectively, and to require less clinician time for fitting. This was a phase II/III, multicenter, randomized, open-label, parallel group study of 841 women at risk for pregnancy. A subset of 42 women at one site underwent colposcopy. Women were randomized to use the FemCap or Ortho All-Flex contraceptive diaphragm, both with 2% nonoxynol-9 spermicide, for 28 weeks. The objectives were to compare the two devices with regard to their safety and acceptability and to determine whether the probability of pregnancy among FemCap users was no worse than that of the diaphragm (meaning not more than 6 percentage points higher). The 6-month Kaplan-Meier cumulative unadjusted typical use pregnancy probabilities were 13.5% among FemCap users and 7.9% among diaphragm users. The adjusted risk of pregnancy among FemCap users was 1.96 times that among diaphragm users, with an upper 95% confidence limit of 3.01. Clinical equivalence (noninferiority) of the FemCap compared with the diaphragm, as defined in this study, would mean that the true risk of pregnancy among FemCap users was no more than 1.73 times the pregnancy risk of diaphragm users. Because the observed upper 95% confidence limit (and even the point estimate) exceeded 1.73, the probability of pregnancy among FemCap users, compared with that among diaphragm users, did not meet the definition of clinical equivalence used in this study. The FemCap was believed to be safe and was associated with significantly fewer urinary tract infections. More women reported problems with the FemCap with regard to insertion, dislodgement, and especially removal, although their general assessments were positive. The two devices were comparable with regard to safety and acceptability, but a 6-point difference in the true 6-month pregnancy probabilities of the two devices could not be ruled out. Further studies are needed to determine whether design modifications can simplify insertion and removal.

Adolescent↗
PubMed1999

FemCap studies.

Explore the source record for details and available documents.

Adolescent↗
PubMed1998

Influence of orthodontic treatment in the primary dentition upon development of the dentition and craniofacial growth.

UNLABELLED: Thirty patients who underwent orthodontic treatment of the primary dentition were examined in this retrospective follow-up study. The mean age at the beginning of treatment was 4.4 (+/= 1.1) years, and at follow-up 15.4 (+/- 1.7) years. Different kinds of malocclusion were present. RESULTS: The early treatment lasted on average 12.3 (+/- 7.2) months. Treatment time of Class III malocclusion and lateral crossbite was significantly shorter than that of Class II, 1 malocclusion, functional Class II, 2 malocclusion or anterior open bite (p < 0.05). A Class I occlusion was achieved in 90% of the patients during treatment of the primary dentition. No patient treated successfully in the primary dentition showed any relapse to initial malocclusion. CONCLUSION: These results suggest that changes in occlusion and mandibular position during treatment in the primary dentition are maintained in the mixed and permanent dentition. It can be concluded that a Class I occlusion following orthodontic treatment in the primary dentition serves as a basis for physiological development of the dentition and craniofacial growth.

Child, Preschool↗
PubMed1996

Lea's Shield: a study of the safety and efficacy of a new vaginal barrier contraceptive used with and without spermicide.

The purpose of this study was to evaluate the safety, efficacy and acceptability of Lea's Shield, a new vaginal contraceptive barrier device, when used with either spermicidal or non-spermicidal lubricant. One-hundred-eighty-five (185) women enrolled at six centers. Half were randomized to use the device with spermicide and half with a non-spermicidal lubricant. To be eligible, volunteers had to be 18-40 years old (inclusive), in good health with regular menses, sexually active in an ongoing relationship and at risk for pregnancy, and willing to use Lea's Shield as their sole means of contraception for six months. Participants were seen at admission, one week, one month, three months and six months. Gross cumulative life table rates were calculated for pregnancy and others reasons for discontinuation. Adverse experiences and responses to an acceptability questionnaire were evaluated. One-hundred-eighty-two (182) volunteers contributed data to the analysis of safety and 146 to that of contraceptive efficacy. The unadjusted six-month life table pregnancy rate was 8.7 per 100 women for spermicide users and 12.9 for non-spermicide users (p = 0.287). After controlling for age, center, and frequent prior use of barrier methods, the adjusted six-month life table pregnancy rate was 5.6 for spermicide users and 9.3 for non-spermicide users (p = 0.086), indicating that use of spermicide lowered pregnancy rates, although not significantly, during typical use. For purposes of comparison, it is important to note that this study differed from the cap/diaphragm and sponge/ diaphragm studies in that a high percentage (84%) of volunteers were parous. For reasons that are unclear, pregnancy rates among parous women using barrier contraceptives tend to be higher than among nulliparous women. Indeed, in this study there were no pregnancies among nulliparous users of Lea's Shield. Standardization of parity of this study population on those of the cap/diaphragm and sponge/diaphragm studies suggests that unadjusted pregnancy rates for this device would have been considerably lower (2.2 and 2.9 per 100 users of spermicide and non-spermicide, respectively) had the study been done using the populations of earlier studies. Since no directly comparative study has been done, these figures provide a tentative estimate of the relative efficacy of Lea's Shield compared with the sponge, cap, and diaphragm. There were no serious adverse experiences attributed to the use of Lea's Shield. Acceptability was very good. Seventy-five percent (75%) of women responded to an end-of-study questionnaire; 87% of these reported that they would recommend Lea's Shield to a friend. Lea's Shield is a new vaginal contraceptive that does not require clinician fitting. Pregnancy rates in this study compare favorably with other studies of barrier contraceptive methods including the cervical cap, diaphragm, and sponge, even though this study was done with greater rigor and with a greater percentage of parous women than previous barrier studies. Lea's Shield appears to be safe and very acceptable to study volunteers.

Adult↗
PubMedDate not supplied

Comparison of chlamydial culture with Chlamydiazyme assay during erythromycin PCE treatment of Chlamydia genital infections.

We compared chlamydial culture with the chlamydial antigen detection enzyme immunoassay system (Chlamydiazyme, Abbott Diagnostic Products; Abbott Park, IL) during treatment of Chlamydia genital infections. Participants received 333 mg of erythromycin PCE (Abbott Laboratories; Abbott Park, IL) 3 times per day for 7 days. On days 0, 3, 7, and 14, chlamydial cultures were positive in 30/30 (100%), 5/29 (17.2%), 0/27, and 0/25 participants, respectively. Concurrent Chlamydiazyme assays were positive in 30/30 (100%), 11/30 (37%), 1/28 (4%), and 0/25 participants. Twenty-eight of 28 persons who received erythromycin PCE for at least 3 days had negative test results for both chlamydial culture and Chlamydiazyme at their last clinic visit. Chlamydiazyme assay tended to remain positive longer than chlamydial culture during treatment, but 7 days after therapy was completed, no Chlamydia trachomatis antigens were detectable by this assay. Erythromycin PCE was well tolerated and rapidly eliminated Chlamydia genital infections in 83% of persons showing negative cultures by the third day of therapy.

Antigens, Bacterial↗