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Safety and Efficacy of Nitric Oxide Gel in Promoting Hair Growth in Male Human Subjects With Androgenetic Alopecia

Primary Purpose

Alopecia Androgenica

Status

Unknown status

Phase

Phase 1

Locations

Taiwan

Study Type

Interventional

Intervention

Nitric Oxide (NO) Gel

Placebo gel

About this trial

This is an interventional treatment trial for Alopecia Androgenica

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Male subjects >= 20 and <= 65 years of age.
Subjects with hair loss caused by androgenetic alopecia.
Subjects who are healthy without any serious diseases that require hospitalization during the study period.
Subjects who are capable of understanding and having signed the Informed Consent Form after detailed description of the treatment procedures and potential risks and benefits.

Exclusion Criteria:

Subjects who received any treatment for hair loss within 6 months or finasteride within 12 months
Subjects with diagnosis of cancer and is still on active therapies.
Subjects with diagnosis of an active disease and is still under regular treatment for this disease
Subjects with hair loss caused by a known chronic disease.
Subjects who are on vasodilators or other medication with pharmacological actions that may lead to excessive formation of nitric oxide or may accentuate drug effects due to excessive formation of nitric oxide.
Subjects with thyroid disease.
Subjects iron-deficiency anemia.
Subjects with skin diseases of the scalp, including severe seborrhoeic dermatitis, psoriasis, lichenoid eruption, tinea capitis, or other scalp infections or infestations
Subjects with any known allergic reaction to any ingredient in the 2 gel preparations.
Subjects who have been enrolled into any clinical study in the preceding 6 months prior to randomization.
Subjects who have taken medications that are known to induce hypotrichosis or hypertrichosis.

Sites / Locations

Dermatological Department, CMUHRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nitric Oxide (NO) Gel

Placebo Gel

Arm Description

Outcomes

Primary Outcome Measures

The primary efficacy endpoint is the difference in TAHC between baseline and after 24-week treatment (NO vs. placebo groups).

Secondary Outcome Measures

The secondary efficacy end point will be subjective assessment of improvement.

Subjects will be instructed to fill out a questionnaire at week 24 to evaluate the overall condition of hair loss in comparison with baseline. Subjects will be evaluated for any possible adverse effects of study drug and any symptoms and signs of scalp irritation (stinging, burning, itching)

Full Information

NCT ID

NCT01347957

First Posted

May 3, 2011

Last Updated

February 12, 2013

Sponsor

China Medical University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01347957

Brief Title

Safety and Efficacy of Nitric Oxide Gel in Promoting Hair Growth in Male Human Subjects With Androgenetic Alopecia

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Unknown status

Study Start Date

August 2012 (undefined)

Primary Completion Date

August 2013 (Anticipated)

Study Completion Date

August 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

China Medical University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Preclinical studies showed the Nitric Oxide (NO) gel significantly promoted hair follicle formation and growth in both rat and mouse models. The NO gel induced major physiological, developmental, and structural changes in the skin of mammals to increase the number of hair follicles, follicle stem cell development and regeneration as well as hair shaft elongation, and accelerated hair growth rate. Based on our animal model findings, the investigators hypothesize that the nitric oxide releasing gel could be used as a medical treatment for hair growth in humans. The objective of this trial is to evaluate the safety and efficacy of this NO gel (XN-001), in comparison with a placebo gel in subjects in a 24-week treatment schedule.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alopecia Androgenica

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Nitric Oxide (NO) Gel

Arm Type

Experimental

Arm Title

Placebo Gel

Arm Type

Placebo Comparator

Intervention Type

Other

Intervention Name(s)

Nitric Oxide (NO) Gel

Intervention Description

Nitric Oxide (NO) Gel is created by premixing of contents from 2 separate gel bottles. The first bottle, NO gel, is a solution of sodium nitrite (14.6mM) in distilled water with hydroxyethylcellulose (molecular weight 50,000-1,250,000) added for gel formation. The second bottle, Releasing-stimulator gel, is a solution of maleic acid (14.6mM) and ascorbic acid (14.6mM) in distilled water with hydroxyethylcellulose added for gel formation.

Intervention Type

Other

Intervention Name(s)

Placebo gel

Intervention Description

The placebo gel is created by premixing of contents from 2 separate gel bottles. The first bottle is phosphate-buffered saline. The second bottle is the second gel bottle (Releasing-stimulator gel) as described in experimental arm.

Primary Outcome Measure Information:

Title

The primary efficacy endpoint is the difference in TAHC between baseline and after 24-week treatment (NO vs. placebo groups).

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

The secondary efficacy end point will be subjective assessment of improvement.

Description

Time Frame

24 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male subjects >= 20 and <= 65 years of age. Subjects with hair loss caused by androgenetic alopecia. Subjects who are healthy without any serious diseases that require hospitalization during the study period. Subjects who are capable of understanding and having signed the Informed Consent Form after detailed description of the treatment procedures and potential risks and benefits. Exclusion Criteria: Subjects who received any treatment for hair loss within 6 months or finasteride within 12 months Subjects with diagnosis of cancer and is still on active therapies. Subjects with diagnosis of an active disease and is still under regular treatment for this disease Subjects with hair loss caused by a known chronic disease. Subjects who are on vasodilators or other medication with pharmacological actions that may lead to excessive formation of nitric oxide or may accentuate drug effects due to excessive formation of nitric oxide. Subjects with thyroid disease. Subjects iron-deficiency anemia. Subjects with skin diseases of the scalp, including severe seborrhoeic dermatitis, psoriasis, lichenoid eruption, tinea capitis, or other scalp infections or infestations Subjects with any known allergic reaction to any ingredient in the 2 gel preparations. Subjects who have been enrolled into any clinical study in the preceding 6 months prior to randomization. Subjects who have taken medications that are known to induce hypotrichosis or hypertrichosis.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

CHIH JUNG HSU

Phone

0953661694

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chih JUNG HSU

Organizational Affiliation

Dermatological department, CMUH

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dermatological Department, CMUH

City

Taichung

Country

Taiwan

Individual Site Status

Recruiting

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy of Nitric Oxide Gel in Promoting Hair Growth in Male Human Subjects With Androgenetic Alopecia

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