An interventional study of Botulinum toxin in Male Intimate Harmonization Methods, sponsored by Antony Barbosa Institute. Completed at 1 site in Brazil. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Antony Barbosa Institute · Not applicable, Interventional, and Treatment
Dissatisfaction with penile size and aesthetics may negatively affect men's self-esteem and quality of life, representing a relevant factor in psychological and sexual health. Intimate aesthetic procedures have increasingly been sought as an alternative to improve body perception and male confidence. Among the available techniques, the use of botulinum toxin and hyaluronic acid-based fillers has demonstrated potential to increase penile circumference and reduce the retraction reflex, providing functional and aesthetic benefits. However, the literature lacks robust studies evaluating the efficacy, safety, and psychological impact of these interventions.
The primary objective of this study is to evaluate the efficacy, safety, and level of satisfaction associated with male intimate harmonization methods using botulinum toxin and hyaluronic acid. In addition, the study aims to analyze the effects of these techniques on patients' self-esteem and body perception, particularly in individuals with small penis syndrome or anxiety related to penile size.
This is a prospective clinical trial. Participants will be selected according to predefined criteria and will undergo an initial evaluation by a urologist. On the first day, Dysport 300SU botulinum toxin will be administered along the length of the penis, with 60% of the volume concentrated near the base. Patients will use a penile extender for at least four hours per day until the follow-up visit, scheduled 15 days after administration. At this visit, measurements of penile length and circumference will be obtained in both flaccid and erect states, followed by the administration of hyaluronic acid for penile filling. The final evaluation will take place after 30 days for a new measurement of the parameters.
The procedures are expected to result in a significant increase in penile size and circumference, as well as improvements in body perception, self-esteem, and sexual satisfaction among participants. Furthermore, this study intends to contribute to the scientific evidence base regarding male intimate aesthetics by providing evidence on the safety and efficacy of the proposed techniques and assisting in the standardization of these interventions in clinical practice.
Antony Barbosa Institute is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Justification: These channels were selected because they allow prior identification of individuals who have already sought aesthetic care or have a direct interest in the procedure, thereby reducing risks and ensuring adherence.
Exclusion Criteria:
/AIDS - Individuals living with HIV/AIDS may present:
However, people living with HIV may participate in the study provided that they receive regular medical follow-up, have an undetectable viral load, and have a compatible with clinical stability, as assessed by the investigator physician.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will undergo a standardized male intimate harmonization protocol consisting of botulinum toxin administration followed by hyaluronic acid penile filling, with clinical, anthropometric, satisfaction, self-esteem, and safety assessments performed throughout the study follow-up period.
Drug: Botulinum toxin
Dysport® 300SU botulinum toxin will be administered along the entire length of the penis, with the amount administered proportional to penile size and circumference. The administration will be divided equally, with 60% of the total volume distributed within 1 cm of the penile base at anatomical points corresponding to the 10 and 2 o'clock, and 9 and 3 o'clock positions.
Change in penile circumference
Change in penile circumference, measured in centimeters at the penile base, midpoint, and immediately below the glans, from D 0 to D 30 after the hyaluronic acid penile filling procedure. Measurements will be obtained in both flaccid and erect states.
Time frame: Day 0 to Day 30 after the hyaluronic acid penile filling procedure
Ran from Apr 2026 to primary completion in Jul 2026, 3 months.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Botulinum Toxins
Antony Barbosa Institute